BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 1902635 · Received November 18, 2010

    Report

    Report Number
    3005099803-2010-04770
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH THE LOT# OF THE DEVICE IS UNKNOWN, THE COMPLAINANT INDICATED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRATION DATE.THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE ANALYSIS OF THE DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: PHYSICAL ANALYSIS OF THE RETURNED MESH ASSEMBLY REVEALED THAT TWO OF THE MESH LEG ASSEMBLY SLEEVES WERE NOT RETURNED. IN ADDITION, THE SOLID BLUE AND BLUE AND WHITE DILATORS WERE MISSING, AND THE NEEDLES WERE PRESENT ON THE TWO DILATORS THAT WERE RETURNED. PHYSICAL ANALYSIS OF THE RETURNED CAPIO DEVICE REVEALED THAT THE CENTER SLOT OF CAPIO CAGE WAS BENT SHUT. ADDITIONALLY, THE CARRIER WAS BENT. FUNCTIONAL ANALYSIS OF THE CAPIO DEVICE REVEALED THAT THE BENT CARRIER DEPLOYED TO THE LEFT OF THE CENTER SLOT. THE DIRECTIONS FOR USE FOR THE DEVICE INCLUDES THE FOLLOWING PRECAUTION STATEMENT: "AVOID EXCESSIVE TENSION ON THE MESH DURING HANDLING AND POSITIONING TO PREVENT DAMAGE TO THE DEVICE." THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE (PROCEDURE DATE UNKNOWN) USING A PINNACLE ANTERIOR/APICAL PFR KIT, WHEN THE PHYSICIAN ATTEMPTED TO PULL BACK ON THE MESH LEG TO SEAT THE NEEDLE IN THE CAPIO DEVICE, THE NEEDLE DETACHED FROM THE MESH LEG, OUTSIDE THE PATIENT. THE PHYSICIAN USED ANOTHER PINNACLE ANTERIOR/APICAL PFR KIT TO COMPLETE THE PROCEDURE, WITHOUT ANY COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST-PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE (PROCEDURE DATE UNKNOWN) USING A PINNACLE ANTERIOR/APICAL PFR KIT, WHEN THE PHYSICIAN ATTEMPTED TO PULL BACK ON THE MESH LEG TO SEAT THE NEEDLE IN THE CAPIO DEVICE, THE NEEDLE DETACHED FROM THE MESH LEG, OUTSIDE THE PATIENT. THE PHYSICIAN USED ANOTHER PINNACLE ANTERIOR/APICAL PFR KIT TO COMPLETE THE PROCEDURE, WITHOUT ANY COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317050

    Patients

    Seq Age Sex Outcome Treatment
    1