BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO¿ SLIM

    MDR report key: 5047426 · Received September 1, 2015

    Report

    Report Number
    3005099803-2015-02390
    Event Type
    Malfunction
    Date Received
    September 1, 2015
    Date of Event
    August 4, 2015
    Report Date
    August 4, 2015
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED CAPIO SLIM REVEALED THAT THE CARRIER IS STUCK IN THE CAGE AND THE CAGE TO BE DAMAGED. THE CARRIER WAS ACTUATED WITH THE SUTURE, IT EXTENDS AND THE NEEDLE ENTERED IN THE SLOT, HOWEVER IT DOES NOT RETRACT. 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. THE INVESTIGATION CONCLUDED THAT SINCE THE ISSUE OCCURRED DURING PREPARATION, THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS HANDLING DAMAGE SINCE THE COMPLAINT WAS CAUSED BY HANDLING OF THE DEVICE DURING UNPACKING, PREPARATION, OR PROCEDURE.

    Additional Manufacturer Narrative · 1

    PROBLEM OF CARRIER WOULD NOT RETRACT. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO SLIM WAS USED DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE CAPIO CARRIER WITH THE NEEDLE GOT STUCK INSIDE THE CAPIO CAGE AND WOULD NOT RETRACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPIO SLIM. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO SLIM WAS USED DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE CAPIO CARRIER WITH THE NEEDLE GOT STUCK INSIDE THE CAPIO CAGE AND WOULD NOT RETRACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPIO SLIM. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578535 CAPIO¿ SLIM HOLDER, NEEDLE, GASTROENTEROLOGIC FHQ BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0068318250 17986321

    Patients

    Seq Age Sex Outcome Treatment
    1