BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIFLEX?

    MDR report key: 3830580 · Received May 23, 2014

    Report

    Report Number
    3005099803-2014-01948
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    April 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: MANUFACTURER NAME IS BOSTON SCIENTIFIC - (B)(4). VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THE WIRE KINKED AND THE HANDLE CANNULA DETACHED. THE HANDLE CANNULA HAS MARKS FROM THE ASSEMBLY PROCESS PERFORMED DURING MANUFACTURING. THE HANDLE WAS DISASSEMBLED, AND NO DAMAGE WAS FOUND ON THE INTERNAL SURFACE OF THE FINGER RING ASSEMBLY. THE COMPLAINT WAS CONFIRMED; THE HANDLE CANNULA WAS DETACHED. HOWEVER, REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILED TO INDICATE A ROOT CAUSE OR PROBABLE ROOT CAUSE FOR THIS EVENT. CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    EVENT: HANDLE CANNULA DETACHED. 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 ON (B)(6) 2014 THAT A CAPTIFLEX SMALL OVAL SNARE WAS USED. ACCORDING TO THE COMPLAINANT, THE SNARE WIRE DETACHED AT THE PULL ROD IN THE HANDLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2014 THAT A CAPTIFLEX SMALL OVAL SNARE WAS USED. ACCORDING TO THE COMPLAINANT, THE SNARE WIRE DETACHED AT THE PULL ROD IN THE HANDLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308664 CAPTIFLEX? SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562422 0016744770

    Patients

    Seq Age Sex Outcome Treatment
    1