BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSATION? SHORT THROW

    MDR report key: 4210676 · Received October 29, 2014

    Report

    Report Number
    3005099803-2014-03553
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 27, 2014
    Report Date
    October 10, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE HANDLE WAS DISMOUNTED AND THE HANDLE WAS NOT BROKEN. ALSO, THE CATHETER IS SEVERELY KINKED IN THE MIDDLE OF THE DEVICE, AND THE DISTAL SECTION APPEARED SMASHED. THE CATHETER IS MELTED AT THE TIP OF THE DISTAL SECTION. DUE TO THE HANDLE BEING DISMOUNTED, FUNCTIONAL AND ELECTRICAL TESTING COULD NOT BE PERFORMED UNTIL THE DEVICE WAS REASSEMBLED. ONCE REASSEMBLED FUNCTIONAL TESTING WAS DONE AND FOUND THAT THE DEVICE EXTENDS AND RETRACTS WITH NO ISSUE. ELECTRICAL TESTING WAS PERFORMED AND RESISTANCE MEASURED AT 10.6 OHMS, WITHIN MANUFACTURING SPECIFICATIONS. THE COMPLAINT WAS CONFIRMED; THE DEVICE IS INOPERABLE SINCE THE HANDLE WAS DISMOUNTED WHICH DOES NOT ALLOW THE DEVICE TO BE ACTUATED. ALSO, THE CATHETER IS SEVERELY KINKED IN THE MIDDLE OF THE DEVICE, AND IT HAS THE DISTAL SECTION SMASHED. ELECTRICAL AND FUNCTIONAL TESTING FOUND THE DEVICE WITHIN SPECIFICATION AFTER THE HANDLE WAS RE-ASSEMBLED. THE FAILURES FOUND WERE PROBABLY CAUSED BY ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THE EVENT IS OPERATIONAL CONTEXT. 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 CONFIRMED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION LARGE OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THE SNARE LOOP WAS EXTENDED AROUND THE POLYP, THEY ATTEMPTED TO DELIVER CURRENT BUT NO SIGNS OF CAUTERY WERE NOTED. IN ORDER FOR THE TISSUE TO BE REMOVED, TWO SMALLER CUTS WERE PERFORMED. ON A THIRD CUT THEY WERE ABLE TO CLOSE THE SNARE BUT IT WOULD NOT OPEN BACK UP AND THE SNARE WIRE APPEARED TO BE STUCK IN THE POLYP. THE DOCTOR USED A BIOPSY FORCEP TO "BITE THROUGH THE STALK OF THE POLYP WITH 3 BITES". THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION 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 SENSATION LARGE OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THE SNARE LOOP WAS EXTENDED AROUND THE POLYP, THEY ATTEMPTED TO DELIVER CURRENT BUT NO SIGNS OF CAUTERY WERE NOTED. IN ORDER FOR THE TISSUE TO BE REMOVED, TWO SMALLER CUTS WERE PERFORMED. ON A THIRD CUT THEY WERE ABLE TO CLOSE THE SNARE BUT IT WOULD NOT OPEN BACK UP AND THE SNARE WIRE APPEARED TO BE STUCK IN THE POLYP. THE DOCTOR USED A BIOPSY FORCEP TO "BITE THROUGH THE STALK OF THE POLYP WITH 3 BITES." THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION 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
    693923 SENSATION? SHORT THROW SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562651 17168655

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention