BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO¿ SLIM

    MDR report key: 5099212 · Received September 23, 2015

    Report

    Report Number
    3005099803-2015-02713
    Event Type
    Malfunction
    Date Received
    September 23, 2015
    Date of Event
    March 31, 2015
    Report Date
    August 28, 2015
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED CAPIO SLIM REVEALED THAT THE DEVICE DOES NOT HAVE ANY VISUAL FAILURE OR FUNCTIONAL ISSUES. THE CARRIER WAS ACTUATED THREE TIMES AND IT EXTENDED WITHOUT ANY PROBLEM. ALSO, IT WAS ACTUATED (DEPLOYED) THREE TIMES WITH THE SUTURE AND THE NEEDLE ENTERED IN THE SLOT AND THE NEEDLE WAS NOT DETACHED. 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 THE PRODUCT RETURNED DOES NOT HAVE THE NEEDLE DETACHED NOR FUNCTIONAL ISSUES. BASED ON ALL GATHERED INFORMATION, NO FURTHER ACTIONS ARE CONSIDERED NECESSARY. THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE PROBLEM OF NEEDLE DETACHMENT. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO SLIM DEVICE WAS USED DURING A TOTAL VAGINAL HYSTERECTOMY, ANTERIOR AND POSTERIOR REPAIR, SLING, SACROSPINOUS SUSPENSION PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND OUTSIDE THE PATIENT, THE NEEDLE WAS NOTICED TO BE MISSING FROM THE SUTURE AFTER THE PHYSICIAN HAD DIFFICULTY LOADING IT TO THE CAPIO SLIM DEVICE. X-RAY OF THE ABDOMEN WAS PERFORMED AND THE RESULT IS NEGATIVE. 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 DEVICE WAS USED DURING A TOTAL VAGINAL HYSTERECTOMY, ANTERIOR AND POSTERIOR REPAIR, SLING, SACROSPINOUS SUSPENSION PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND OUTSIDE THE PATIENT, THE NEEDLE WAS NOTICED TO BE MISSING FROM THE SUTURE AFTER THE PHYSICIAN HAD DIFFICULTY LOADING IT TO THE CAPIO SLIM DEVICE. X-RAY OF THE ABDOMEN WAS PERFORMED AND THE RESULT IS NEGATIVE. 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
    628757 CAPIO¿ SLIM HOLDER, NEEDLE, GASTROENTEROLOGIC FHQ BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0068318261 17099058

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR