BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE

    MDR report key: 1220418 · Received October 31, 2008

    Report

    Report Number
    3005099803-2008-05823
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    June 30, 2008
    Report Date
    October 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOST PROBABLE CAUSE OF FAILURE HAS BEEN ATTRIBUTED TO "OPERATIONAL CONTEXT". THIS IS BASED ON THE ANALYSIS OF THE DEVICE, WHICH REVEALS THE CARRIER HEAD FRACTURED. SEM (SCAN ELECTRON MICROSCOPE) ANALYSIS OF THE FRACTURE, WHICH IS A SECONDARY ANALYSIS FINDING, DETERMINED THAT THE FRACTURE OCCURRED AS A RESULT OF "A SIDE IMPACT AND OR BENDING OVERLOAD MOMENT". THE CARRIER HEAD BEING FRACTURED WOULD NOT HAVE ALLOWED THE DEVICE TO CATCH THE NEEDLE DURING THE PROCEDURE. ALL EVIDENCE SUGGESTS THAT AT SOME TIME DURING THE PROCEDURE, THE CARRIER HEAD ENCOUNTERED A SIDE IMPACT OR BENDING OVERLOAD DURING USE THAT CAUSED THE FINAL FRACTURE OF THE CARRIER HEAD. THE CUSTOMER DID NOT ALLEGE HAVING NOTED THIS CONDITION PRIOR TO USE. DEVICE HISTORY RECORD REVIEW REVEALS NO ANOMALIES RELATED TO THE COMPLAINT. LOT MET ALL SPECIFICATIONS RELEVANT TO COMPLAINT UPON LOT RELEASE.

    Description of Event or Problem · 1

    DURING THE EVALUATION OF THE CAPIO ACCESS SUTURE CAPTURING DEVICE IN 2008, IT WAS OBSERVED THAT THE DEVICE HAD A FRACTURED CARRIER. THIS WAS NOT INDICATED BY THE COMPLAINANT WHEN THE INITIAL EVENT DESCRIPTION WAS PROVIDED TO BOSTON SCIENTIFIC. IT WAS REPORTED THAT THREE MONTHS PRIOR, THE DEVICE DID NOT CAPTURE THE NEEDLE DURING AN UNKNOWN SUTURE PROCEDURE. FOLLOW-UP INFORMATION OBTAINED FROM THE COMPLAINANT APPROX TWO MONTHS PRIOR TO ORIGINAL MONTH, INDICATED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE; THERE WERE NO COMPLICATION FOR THE PATIENT AND THE PATIENT'S CONDITION WAS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE FHQ BOSTON SCIENTIFIC CORPORATION M0068311251 11522161

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK