BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO? SLIM

    MDR report key: 3727246 · Received April 4, 2014

    Report

    Report Number
    3005099803-2014-01645
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) SUTURE DETACHED ALTHOUGH THE SUSPECTED 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE RETURNED CAPIO SLIM DEVICE CONFIRMED THAT THE DEVICE DIDN'T HAVE ANY DAMAGES. THE CARRIER WAS NOT FOUND BENT, AND THE NEEDLE USED AT THE PROCEDURE WAS NOT RETURNED THEREFORE IT IS NOT POSSIBLE TO DETERMINE IF THE NEEDLE WAS DETACHED OR NOT. THE DEVICE WAS ACTUATED THREE TIMES AND IT EXTENDED WITHOUT ANY PROBLEM. THEN IT WAS ACTUATED THREE TIMES WITH THE SUTURE AND NO ANOMALIES WERE OBSERVED. THEREFORE THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED SINCE THE COMPLAINT INCLUDED A RETURNED DEVICE REVIEW WHICH SHOWED NO EVIDENCE OF EITHER THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. 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 COMPLAINT WAS NOT CONFIRMED. THE DEVICE DID NOT SHOW ANY EVIDENCE OF EITHER THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. VOLUNTARY USER MEDWATCH NUMBER IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO SLIM SINGLE WAS USED DURING A PELVIC PROLAPSE SURGERY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, AFTER THE SUTURE AND NEEDLE WAS LAUNCHED, THE NEEDLE DETACHED WHEN THE PHYSICIAN WAS PULLING THE CAPIO DEVICE. AN IMAGING SCAN WAS DONE TO DETERMINE THE LOCATION OF THE NEEDLE BUT THEY WERE UNABLE TO LOCATE IT. INSPECTION WAS DONE ON THE DEVICE, IT WAS NOTICED THAT NEEDLE CARRIER WAS BENT AND THE NEEDLE LODGED INSIDE THE CAGE. NOTHING WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPIO SLIM SINGLE. 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 FAIR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO SLIM SINGLE WAS USED DURING A PELVIC PROLAPSE SURGERY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, AFTER THE SUTURE AND NEEDLE WAS LAUNCHED, THE NEEDLE DETACHED WHEN THE PHYSICIAN WAS PULLING THE CAPIO DEVICE. AN IMAGING SCAN WAS DONE TO DETERMINE THE LOCATION OF THE NEEDLE BUT THEY WERE UNABLE TO LOCATE IT. INSPECTION WAS DONE ON THE DEVICE, IT WAS NOTICED THAT NEEDLE CARRIER WAS BENT AND THE NEEDLE LODGED INSIDE THE CAGE. NOTHING WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPIO SLIM SINGLE. 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 FAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203827 CAPIO? SLIM HOLDER, NEEDLE, GASTROENTEROLOGIC FHQ BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0068318261 16366912

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR