High Quality Sealing - Valve Introducer Catheter 의 안전성 경고

Safety alert

2016-02-05

2016-02-05

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20160205.html

Medical device safety alert: acist medical systems high quality sealing - valve introducer catheter medical device manufacturer, acist medical systems inc., has issued a medical device safety alert concerning its high quality sealing (hqs) - valve introducer catheter. the affected products are identified as follows: reference number.: 2064-hqs-10f-100 (lot number.: 14/751, 14/638) reference number.: 2064-hqs-16f-140 (lot number: 14/300,, 13/418, 13/417, 13/147) reference number: 2064-hqs-16f-300 (lot number: 14/726) reference number: 2064-hqs-18f-140 (lot number: 15/392, 11/427, 11/325, 12/425, 11/426, 11/118) reference number: 2064-hqs-18f-200 (lot number: 15/115) reference number: 2064-hqs-18f-300 (lot number: 12/424, 11/429) reference number: 2064-hqs-20f-140 (lot number: 11/326, 11/079) reference number: 2064-hqs-20f-200 (lot number: 15/114) reference number: 2064-hqs-20f-300 (lot number: 11/327, 11/117, 11/114) reference number: 2064-hqs-22f-140 (lot number: 12/148, 11/082, 11/078) reference number: 2064-hqs-22f-300 (lot number: 14/611, 14/505, 14/168, 12/149, 11/077) reference number: 2064-hqs-24f-140 (lot number: 13/427) reference number: 2064-hqs-26f-140 (lot number: 11/084) the manufacturer was informed of breakage of hqs introducers extremity during use and they observed that some batches of the hqs introducers present a risk of partial break of the end of sheath tubing. an extended light exposure of these sheath tubings (stored before manufacturing) is at the origin of this risk, which is significantly increased in case an effort is required during the insertion, the endovascular tool passage or the removal of the hqs introducer sheath. the manufacturer did not identify any additional risk for the patient, for whom the introducer has been used without incident with the sheath extremity. adverse events can occur following the partial break of this extremity, such as a medical intervention to retrieve a loose segment or complications due to the loose end occluding blood flow towards the irrigated organs. according to the manufacturer, there is no report or description of illness or injury linked to this potential hazardous situation. the manufacturer advises customers to quarantine the affected products. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 february 2016.