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Model Number BFR1070KD-A |
Device Problem
Leak/Splash (1354)
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Patient Problems
Hematoma (1884); Pain (1994)
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Event Date 12/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Currently waiting for the device to be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Catheter was placed in the left femoral vein.Patient started to have burning sensation in groin area, on the same day local hematoma appeared.Patient went to operating room, and on ctc scan with contrast it was seen 2 ruptures on catheter.First rupture was in the tunnel, and second rupture was at the connection of cuff and catheter.
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Manufacturer Narrative
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Although reported the device would be returned for evaluation, no device was received and no photographs were provided.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured, assembled, and inspected according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test performed as the last step in the process.This test would have detected any holes, leaks, or weak areas if they had existed at the time of manufacture.Without an evaluation of the device a root cause cannot be determined.The catheter was placed in the femoral vein and was implanted for 1 years 3 months prior to the incident.The femoral vein is not indicated as a placement site in the instructions for use.A literature review indicates the femoral vein provides an alternative access site for insertion of tunneled hemodialysis catheters when conventional sites are not available.However, tunneled femoral hemodialysis catheters have low primary patency rates and significant complications.
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Search Alerts/Recalls
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