BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES

    MDR report key: 1993957 · Received February 16, 2011

    Report

    Report Number
    3005099803-2011-00397
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND NO ISSUES. THE UNIT EXTENDED AND RETRACTED AS INTENDED, AND IT PASSED AN ELECTRICAL RESISTANCE TEST (DEVICE READ AT LESS THAN 20 OHMS). IT WAS CONFIRMED THAT THE RETURNED DEVICE MET ALL MANUFACTURING SPECIFICATIONS. THE CONDITION OF THE RETURNED INCIDENT DEVICE SHOWED NO EVIDENCE OF ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT; A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, THE DIRECTIONS FOR USE (DFU) SUGGEST THAT "THE OPERATOR AND THE ASSISTANT WEAR PROTECTIVE GLOVES TO PREVENT ACCIDENTAL BURNS." A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 THAT A CAPTIFLEX STANDARD OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, WHEN THE SNARE WAS LOOPED AROUND THE TARGET POLYP, THE PHYSICIAN AND NURSE NOTICED THAT CAUTERY WAS NOT WORKING. IT WAS SUSPECTED THAT A SYSTEM COMPONENT WAS NOT PLUGGED IN TIGHTLY, SO ALL CONNECTIONS TO THE NON-BSC UNIT WERE CHECKED, WHICH RESOLVED THE ISSUE. AT THIS TIME, HOWEVER, THE NURSE BURNT HER FINGER ON THE BARE METAL SPOT BETWEEN THE FINGER LOOPS ON THE SNARE HANDLE, CAUSING A BLISTER. THE BURN WAS NOT SEVERE; NO TREATMENT WAS NECESSARY. NO VISIBLE DEFECTS WERE NOTED TO THE DEVICE, WHICH WAS USED TO COMPLETE THE PROCEDURE. FOLLOWING THE PROCEDURE, THE UNIT WAS INSPECTED BY A BIOMED AT (B)(6), WHO FOUND THAT A SIGNIFICANT AMOUNT OF HEAT WAS BEING GENERATED AT THE METAL SITE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS NOT HARMED DURING THE PROCEDURE AND WAS SENT HOME, AND THE NURSE'S CONDITION WAS REPORTED TO BE VERY GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX STANDARD OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, WHEN THE SNARE WAS LOOPED AROUND THE TARGET POLYP, THE PHYSICIAN AND NURSE NOTICED THAT CAUTERY WAS NOT WORKING. IT WAS SUSPECTED THAT A SYSTEM COMPONENT WAS NOT PLUGGED IN TIGHTLY, SO ALL CONNECTIONS TO THE NON-BSC UNIT WERE CHECKED, WHICH RESOLVED THE ISSUE. AT THIS TIME, HOWEVER, THE NURSE BURNT HER FINGER ON THE BARE METAL SPOT BETWEEN THE FINGER LOOPS ON THE SNARE HANDLE, CAUSING A BLISTER. THE BURN WAS NOT SEVERE; NO TREATMENT WAS NECESSARY. NO VISIBLE DEFECTS WERE NOTED TO THE DEVICE, WHICH WAS USED TO COMPLETE THE PROCEDURE. FOLLOWING THE PROCEDURE, THE UNIT WAS INSPECTED BY A BIOMED AT (B)(6), WHO FOUND THAT A SIGNIFICANT AMOUNT OF HEAT WAS BEING GENERATED AT THE METAL SITE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS NOT HARMED DURING THE PROCEDURE AND WAS SENT HOME, AND THE NURSE'S CONDITION WAS REPORTED TO BE VERY GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA M00562402 0013897453

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other