BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELSOFT PATCH

    MDR report key: 1321304 · Received February 5, 2009

    Report

    Report Number
    9612515-2009-00003
    Event Type
    Other
    Date Received
    February 5, 2009
    Report Date
    February 5, 2009
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT - UNKNOWN. SAME DAY AS IMPLANT DAY. DEVICE TO BE ANALYZED. RESULTS - DEVICE CURRENTLY UNDERGOING INVESTIGATION, OTHER TESTS ARE BEING IDENTIFIED. CONCLUSIONS: VASCUTEK WILL RESPOND THE SURGEON AND PROVIDE DETAILS OF OUR INVESTIGATION IN OUR FINAL REPORT. VASCUTEK HAD PREVIOUSLY RECEIVED A COMPLAINT ON BLOOD LEAKAGE ALSO CONCERNING A GELSOFT PATCH BATCH NO. 93321/4A FROM A HOSPITAL IN THE (B)(6) IN (B)(6) 2008. IT WAS ALLOCATED COMPLAINT (B)(4). THERE WAS NO DEATH OR SERIOUS INJURY. ON THE 8TH JANUARY, VASCUTEK RECEIVED REPORTS OF SIX (6) MORE LEAKAGE OCCURRENCES FROM (B)(6). IN SUMMARY VASCUTEK RECEIVED A TOTAL OF EIGHT (8) LEAKAGE REPORTS, SEVEN (7) FROM (B)(6) GENERAL REPORTED BY MR. (B)(6) AND ONE (1) FROM (B)(6) (THIS COMPLAINT). WE WERE SUBSEQUENTLY INFORMED THAT MR. (B)(6) WAS ONLY CONCERNED WITH TWO (2) LEAKAGE REPORTS AND NOT SEVEN (7) AS INITIALLY REPORTED. DUE TO THE APPARENT INCREASED FREQUENCY REPORTED FROM THE CENTRE IN (B)(6) AND THE ONE IN (B)(6), VASCUTEK DECIDED TO CONDUCT AN INVESTIGATION AND AS A PRECAUTION RETRIEVE ALL THE AFFECTED BATCHES FROM THE FIELD. THIS HAS NOW BEEN COMPLETED AND NONE OF THE AFFECTED DEVICES ARE AVAILABLE FOR IMPLANT. THE RECONCILIATION FIGURES ARE GIVEN BELOW. A LARGE NUMBER OF DEVICES WERE NEVER DISPATCHED, BUT REMAINED IN STORES. A REVIEW OF THE MANUFACTURING AND QC RECORDS DID NOT SHOW ANYTHING UNTOWARD. (B)(4) DEVICES HAVE BEEN SUCCESSFULLY IMPLANTED AND THE CENTRES HAVE REPORTED THAT THERE HAVE BEEN NO PROBLEMS. AS STATED PREVIOUSLY, DUE TO THE APPARENT INCREASED FREQUENCY REPORTED FROM THE CENTRE IN (B)(6) AND THE ONE IN (B)(6), VASCUTEK DECIDED TO CONDUCT AN INVESTIGATION AND AS A PRECAUTION RETRIEVE ALL THE AFFECTED BATCHES FROM THE FIELD. THERE WERE NO EVENTS IN THE USA. THERE WERE NO DEVICES RETRIEVED FROM THE USA. THERE WERE NO SUPPLY PROBLEMS TO THE USA. A THOROUGH INVESTIGATION AND TESTING PROGRAM HAS BEEN COMPLETED AND VASCUTEK HAVE CONCLUDED THAT THERE IS NO SYSTEMIC PROBLEM WITH THIS PRODUCT. THE MANUFACTURE AND DISTRIBUTION OF GELSOFT PATCHES HAS RECOMMENCED.

    Description of Event or Problem · 1

    THE EVENT OCCURRED IN (B) (6) AT (B) (6). THE EVENT IS BEING REPORTED DUE TO INTERVENTION BEING REQUIRED DURING THE COURSE OF THE IMPLANT PROCEDURE. THERE WAS NO DEATH OR SERIOUS INJURY. THE DATE OF IMPLANT IS NOT KNOWN. THE PATCH WAS IMPLANTED, AFTER RELEASE OF BLOOD FLOW, THERE WAS LEAKAGE FROM THE PATCH. THE PATCH WAS EXPLANTED, IT IS NOT KNOWN IF A REPLACEMENT PATCH WAS USED, OR IF THE ARTERY WAS CLOSED WITH SUTURES. THE PATIENT'S POST-OPERATIVE CONDITION WAS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELSOFT PATCH VASCULAR PROSTHESIS DSY VASCUTEK LTD. UNKNOWN 93321/4A 1152

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention