BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ XL STENT PER 40MM UNMOUNTED

    MDR report key: 3837890 · Received May 29, 2014

    Report

    Report Number
    1016427-2014-00063
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K993091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: WHEN THE PHYSICIAN REMOVED A 40MM PALMAZ UNMOUNTED XL STENT FROM ITS STERILE POUCH, IT WAS REPORTED THAT THE STRUT OF THE EDGE WAS TURNED UP. THEREFORE, THE PHYSICIAN STOPPED USING IT AND A NON-CORDIS BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITHOUT STENT PLACEMENT. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS NOT CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS. THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE IFU GUIDELINES. THE DEVICE/PACKAGING WAS NOT MISHANDLED IN ANY WAY. THERE WAS NO DAMAGE TO THE PACKAGING. THE PROCEDURE WAS COMPLETED WITH PLAIN OLD BALLOON ANGIOPLASTY (POBA). IT IS UNKNOWN WHICH STRUT WAS TURNED UP. NORMAN NOBLE PERFORMED A DOCUMENT HISTORY RECORD REVIEW OF THE BATCH RECORDS IN QUESTION NNI JOB NUMBER 32273-2 NNI LOT NUMBER N121231 0 VIA NNI ERP SYSTEM. THERE WERE NO ANOMALIES FOUND AND THE PRODUCT WAS PACKAGED AND LABELLED TO ALL CORDIS SPECIFICATIONS. THE STENT AND PACKAGING WILL NOT BE RETURNED. CONCLUSION: THE DHR REVEALED NOTHING THAT WOULD LEAD NORMAN NOBLE TO BELIEVE THAT THERE HAD BEEN ANY EVIDENCE THAT THE ROOT CAUSE WOULD HAVE DERIVED FROM NNI. ALSO, WITHOUT THE STENT AND THE PACKAGING FOR REVIEW NO ROOT CAUSE CAN BE IDENTIFIED. WITHOUT RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED ¿STENT - STRUT UPLIFT¿ COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, FACTORS CONTRIBUTING TO THE DAMAGE COULD NOT BE DETERMINED. THE DHR DOES NOT SUGGEST THAT THE ISSUE COULD BE RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    WHEN THE PHYSICIAN REMOVED A 40MM PALMAZ UNMOUNTED XL STENT FROM ITS STERILE POUCH, IT WAS REPORTED THAT THE STRUT OF THE EDGE WAS TURNED UP. THEREFORE, THE PHYSICIAN STOPPED USING IT AND A NON-CORDIS BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITHOUT STENT PLACEMENT. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS NOT CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS. THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE IFU GUIDELINES. THE DEVICE/PACKAGING WAS NOT MISHANDLED IN ANY WAY. THERE WAS NO DAMAGE TO THE PACKAGING. THE PROCEDURE WAS COMPLETED WITH PLAIN OLD BALLOON ANGIOPLASTY (POBA). IT IS UNKNOWN WHICH STRUT WAS TURNED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315990 PALMAZ XL STENT PER 40MM UNMOUNTED ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS CORPORATION NA N1212310

    Patients

    Seq Age Sex Outcome Treatment
    1 CODA BALLOON, COOK