Model Number IGK0008-70 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
Blood Loss (2597)
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Event Date 11/22/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device history records review concludes that there is no non-conformance / planned deviation in relation with the event reported.Device is not accessible for testing as it remained implanted in the patient.The review of historical data indicated that one other bleeding was reported for the same product family and same sterilization lot number.However it was a different use of the product (off label use).One retention sample coated on the same day and under the same conditions as the involved device was identified.A water permeability test will be performed.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.Device remained implanted.
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Event Description
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When the prosthesis was implanted (left femoro femoral bypass), it began to sweat all the way through with blood droplets.After a few minutes, there is a stop of the leak.Decision to leave the prosthesis in place.
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Manufacturer Narrative
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(4102/213) one retention sample coated on the same day and under the same conditions as the involved device underwent water permeability testing.The test result indicated a value well within product specifications (< 5 ml/cm²/min).(67) no conclusion can be drawn since the product remained implanted.However, the conducted investigation suggests that the product was not defective at the time of manufacturing.(22) please note that blood leakage is a foreseeable side-effect as indicated in the instructions for use.
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Event Description
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See initial mfr report # 1640201-2019-00092.Complaint # (b)(4).
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Search Alerts/Recalls
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