BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 2003226 · Received February 28, 2011

    Report

    Report Number
    3005099803-2011-00520
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    January 26, 2011
    Report Date
    February 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATIONVISUAL ANALYSIS OF THE RETURNED MESH BODY ASSEMBLY REVEALED THAT THE BLUE DILATOR WAS SPLIT AND FRAYED, AND THE NEEDLE WAS DETACHED. VISUAL ANALYSIS OF THE RETURNED CAPIO DEVICE REVEALED THAT A NEEDLE WAS INSIDE THE CAPIO CAGE.FUNCTIONAL EVALUATION OF THE RETURNED CAPIO DEVICE REVEALED THAT THE DEVICE OPERATED FREELY AND SMOOTHLY.A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT.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 WAS DETERMINED TO BE OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MANUFACTURER REPORT #3005099803-2011-00521.IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ANTERIOR REPAIR PROCEDURE USING A PINNACLE ANTERIOR APICAL PELVIC FLOOR REPAIR KIT, AS THE PHYSICIAN WAS THROWING A MESH LEG ASSEMBLY THROUGH THE SACROSPINOUS LIGAMENT, THE NEEDLE DETACHED AND WAS CAPTURED INSIDE THE CAPIO CAGE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A THIRD PINNACLE ANTERIOR APICAL PELVIC FLOOR REPAIR KIT WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "GREAT" POST-PROCEDURE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MANUFACTURER REPORT #3005099803-2011-00521.IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ANTERIOR REPAIR PROCEDURE USING A PINNACLE ANTERIOR APICAL PELVIC FLOOR REPAIR KIT, AS THE PHYSICIAN WAS THROWING A MESH LEG ASSEMBLY THROUGH THE SACROSPINOUS LIGAMENT, THE NEEDLE DETACHED AND WAS CAPTURED INSIDE THE CAPIO CAGE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A THIRD PINNACLE ANTERIOR APICAL PELVIC FLOOR REPAIR KIT WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "GREAT" 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 1ML0032501

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR PINNACLE ANTERIOR APICAL PELVIC FLOOR REPAIR KIT