BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIFLEX?

    MDR report key: 4192370 · Received October 22, 2014

    Report

    Report Number
    3005099803-2014-03450
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE FLARE WAS DETACHED AND CATHETER WAS SLIGHTLY KINKED. THE HANDLE CANNULA IS IN GOOD CONDITION. EVIDENCE OF THE FLARE MANUFACTURING PROCESS WAS PRESENT ON THE CATHETER. THE COMPLAINT WAS CONFIRMED, THE FLARE DETACHED. IN ADDITION, THE CATHETER WAS FOUND KINKED. THE COMPLAINANT REPORTED THAT THEY WERE REPOSITIONING THE SCOPE WHEN THE MALFUNCTION OCCURRED. THE REPOSITIONING OF THE SCOPE COULD HAVE CAUSED THE REPORTED MALFUNCTION TO OCCUR HOWEVER REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILED TO INDICATE A DEFINITE ROOT CAUSE OF THIS COMPLAINT. 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. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF WORKING LENGTH DETACHED. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX MEDIUM OVAL SNARE WAS DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(4) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THEY REMOVED A POLYP, THE SNARE WAS PULLED BACK INSIDE THE TIP OF THE SCOPE FOR REPOSITIONING TO REMOVE ANOTHER POLYP. WHEN THEY DID SO, THE PLASTIC SHEATH DETACHED FROM THE HANDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIFLEX SNARE. 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX MEDIUM OVAL SNARE WAS DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THEY REMOVED A POLYP, THE SNARE WAS PULLED BACK INSIDE THE TIP OF THE SCOPE FOR REPOSITIONING TO REMOVE ANOTHER POLYP. WHEN THEY DID SO, THE PLASTIC SHEATH DETACHED FROM THE HANDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIFLEX SNARE. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672900 CAPTIFLEX? SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562402 0017061758

    Patients

    Seq Age Sex Outcome Treatment
    1