BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES

    MDR report key: 1892129 · Received November 8, 2010

    Report

    Report Number
    3005099803-2010-04576
    Event Type
    Injury
    Date Received
    November 8, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE PRESENTED WITH THE TIP OF THE LOOP WIRE BENT. FUNCTIONALLY, THE UNIT EXTENDED/RETRACTED AS INTENDED. ALSO, A RESISTANCE TEST WAS PERFORMED AND THE SNARE WAS WITHIN SPECIFICATION. ALTHOUGH THE TIP OF THE SNARE LOOP WAS BENT, THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE REPORTED ISSUE OF INABILITY TO DELIVER CAUTERY. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4) THE REPORTED EVENT OF DEVICE LOOP BENT. (B)(4) THE REPORTED EVENT OF WIRE FAILED TO DELIVER CURRENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A CAPTIVATOR MICRO HEX POLYPECTOMY SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON A MALE PATIENT IN HIS (B)(6) ON (B)(6), 2010 (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE GI TECHNICIAN WAS OPENING THE SNARE INSIDE THE COLON, IT WAS NOTICED THAT THE TIP OF THE LOOP WAS BENT. THE BENT LOOP WAS CLOSED AROUND A POLYP, BUT A CURRENT FAILURE OCCURED AND COLD SNARE (NO CAUTERY) WAS THEN USED TO REMOVE THE POLYP, RESULTING IN "EXCESSIVE" BLEEDING. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR MICRO HEX POLYPECTOMY SNARE, WHICH EFFECTIVELY STOPPED THE BLEEDING. 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 ON OCTOBER 15, 2010 THAT A CAPTIVATOR MICRO HEX POLYPECTOMY SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON A MALE PATIENT IN HIS MID 60'S ON (B)(6) 2010 (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE GI TECHNICIAN WAS OPENING THE SNARE INSIDE THE COLON, IT WAS NOTICED THAT THE TIP OF THE LOOP WAS BENT. THE BENT LOOP WAS CLOSED AROUND A POLYP, BUT A CURRENT FAILURE OCCURRED AND COLD SNARE (NO CAUTERY) WAS THEN USED TO REMOVE THE POLYP, RESULTING IN "EXCESSIVE" BLEEDING. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR MICRO HEX POLYPECTOMY SNARE, WHICH EFFECTIVELY STOPPED THE BLEEDING. 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
    1 PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA M00562451 13379407

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention