BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE SNARE

    MDR report key: 3833303 · Received May 27, 2014

    Report

    Report Number
    3005099803-2014-02053
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 29, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K992477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. (B)(4) FOR THE REPORTED EVENT OF SHEATH DETACHED. THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE RETURNED PRODUCT FOUND THE FLARE DETACHED. THE CATHETER HAD NO KINKS, AND EXHIBITED EVIDENCE OF THE FLARE PROCESS PERFORMED DURING MANUFACTURING. THE CONDITION OF THE DEVICE RENDERED FUNCTIONAL TESTING IMPOSSIBLE. THE COMPLAINT WAS CONFIRMED; THE DETACHED FLARE PREVENTED SNARE EXTENSION. GIVEN THE EVENT DESCRIPTION AND THE CONDITION OF THE RETURNED DEVICE, THERE ISN'T ENOUGH INFORMATION TO CONCLUDE A PROBABLE ROOT CAUSE. THERE IS AN INVESTIGATION IN PLACE TO ADDRESS FLARE DETACHMENT ISSUES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL SNARE WAS USED IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE SNARE FAILED TO EXTEND DURING FUNCTIONAL TESTING. THE USER CHECKED THE DEVICE AGAIN AND DISCOVERED THAT THE SHEATH HAD DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE MEDIUM OVAL 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL SNARE WAS USED IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE SNARE FAILED TO EXTEND DURING FUNCTIONAL TESTING. THE USER CHECKED THE DEVICE AGAIN AND DISCOVERED THAT THE SHEATH HAD DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE MEDIUM OVAL 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311552 ROTATABLE SNARE SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00561831 0016634162

    Patients

    Seq Age Sex Outcome Treatment
    1