Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Balt extrusion received complaints related to ruptures or inflations of sonic microcatheters during the injections of contrast liquid or embolic agents. sonic microcatheters are designed to be thin and very flexible which allows them to reach very distal locations. special attention must be given during the injections in order to avoid any complications related to overpressure. hence a customer letter was created and is being distributed to remind users to follow the instructions in the ifu to prevent incidents due to overpressure.
Model Catalog: SONIC 1.5F15 (Lot serial: ALL LOTS); Model Catalog: SONIC 1.2F35 (Lot serial: ALL LOTS); Model Catalog: SONIC 1.2F15SG (Lot serial: ALL LOTS); Model Catalog: SONIC 1.2F/15 (Lot serial: ALL LOTS); Model Catalog: SONIC 1.2F/25 (Lot serial: ALL LOTS); Model Catalog: SONIC 1.5F15SG (Lot serial: ALL LOTS)
제품 설명
SONIC - BRAIDED MICROCATHETER WITH PROGRESSIVE SUPPLENESS