BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUFLEX? PLUS

    MDR report key: 3133609 · Received May 29, 2013

    Report

    Report Number
    3005099803-2013-04076
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FGE
    PMA / PMN Number
    K924608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE POUCH IS TORN ON THE TOP LEFT SIDE. THE TORN AREA IS APPROXIMATELY 3 CM. THE UNIT RETURNED PRESENTED THE POUCH WAS BROKEN, AS PART OF OVERALL VISUAL REVISION. THE COMPLAINT WAS CONFIRMED. MOREOVER, THE DEVICE PRESENTED MARKS OF A SHARP OBJECT THAT WAS PRESSED OVER THE POUCH AT THE RIPPED AREA WHICH IS AN EVIDENCE OF MANIPULATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DEVIATIONS WERE FOUND. MOREOVER THE UNITS ARE 100% INSPECTED TO AVOID ANY FAILURE THAT COULD AFFECT THE STERILE BARRIER. NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS FAILURE. BASED ON ALL GATHERED INFORMATION THE MOST PROBABLE CAUSE FOR THIS COMPLAINT IS CONSIDERED HANDLING DAMAGE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING UNPACKING ON (B)(6) 2013, A COMPROMISED STERILE PACKAGE BARRIER WAS NOTED. DURING UNPACKING OF A PERCUFLEX PLUS URETERAL STENT, A RIP WAS FOUND ON THE PACKAGE AND LOSS OF STERILIZATION WAS SUSPECTED. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING UNPACKING ON (B)(6) 2013, A COMPROMISED STERILE PACKAGE BARRIER WAS NOTED. DURING UNPACKING OF A PERCUFLEX PLUS URETERAL STENT, A RIP WAS FOUND ON THE PACKAGE AND LOSS OF STERILIZATION WAS SUSPECTED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235859 PERCUFLEX? PLUS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0061752740 15898273

    Patients

    Seq Age Sex Outcome Treatment
    1