BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPTIFLEX¿

    MDR report key: 2677948 · Received August 1, 2012

    Report

    Report Number
    3005099803-2012-03106
    Event Type
    Injury
    Date Received
    August 1, 2012
    Date of Event
    July 11, 2012
    Report Date
    July 11, 2012
    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
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS CUT INTO TWO PIECES, WHICH IS CONSISTENT WITH COMPLAINANT'S REPORT THAT THE DEVICE HANDLE WAS CUT OFF. VISUAL EVALUATION FOUND THE LOOP TO BE BENT, AND A KINK WAS FOUND IN THE SHEATH NEAR THE HANDLE. THE CAUTERY PIN AND HANDLE CANNULA WERE INSPECTED AND WERE FOUND TO BE WITHIN SPECIFICATIONS. THE CONDITION OF THE RETURNED DEVICE RENDERED SUBSEQUENT FUNCTIONAL AND ELECTRICAL TESTING IMPOSSIBLE. AS THE RETURNED DEVICE COULD NOT BE EVALUATED WITH RESPECT TO CURRENT FAILURE, THE COMPLAINT COULD NOT BE CONFIRMED. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILS TO INDICATE A PROBABLE ROOT CAUSE FOR THIS EVENT. 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 DEVIATION WAS FOUND.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT: SNARE FAILED TO TRANSMIT CURRENT. THE REPORTED EVENT: SNARE EMBEDDED IN TARGET MASS. 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 THAT A CAPTIFLEX STANDARD OVAL SNARE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE SNARE WAS POSITIONED AROUND THE TARGET MASS IN THE ANTRUM OF THE PATIENT'S STOMACH, BUT FAILED TO TRANSMIT CURRENT WHEN THE PHYSICIAN ATTEMPTED TO APPLY CAUTERY. THE ELECTROSURGICAL UNIT WAS REPLACED, WHICH DID NOT RESOLVE THE ISSUE, SO THE PHYSICIAN EMPLOYED FORCEPS TO OBTAIN SAMPLES AND HELP EXTRICATE THE SNARE. THE DEVICE HANDLE WAS CUT OFF AND THE ENDOSCOPE WAS REMOVED FROM THE PATIENT. AFTER THE MASS WAS "PICKED APART," THE REMAINING DISTAL PORTION OF THE DEVICE WAS REMOVED THROUGH THE PATIENT'S MOUTH, THUS COMPLETING THE PROCEDURE. THE PATIENT'S CONDITION WAS REPORTED TO BE "FINE" FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX STANDARD OVAL SNARE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE SNARE WAS POSITIONED AROUND THE TARGET MASS IN THE ANTRUM OF THE PATIENT'S STOMACH, BUT FAILED TO TRANSMIT CURRENT WHEN THE PHYSICIAN ATTEMPTED TO APPLY CAUTERY. THE ELECTROSURGICAL UNIT WAS REPLACED, WHICH DID NOT RESOLVE THE ISSUE, SO THE PHYSICIAN EMPLOYED FORCEPS TO OBTAIN SAMPLES AND HELP EXTRICATE THE SNARE. THE DEVICE HANDLE WAS CUT OFF AND THE ENDOSCOPE WAS REMOVED FROM THE PATIENT. AFTER THE MASS WAS "PICKED APART," THE REMAINING DISTAL PORTION OF THE DEVICE WAS REMOVED THROUGH THE PATIENT'S MOUTH, THUS COMPLETING THE PROCEDURE. THE PATIENT'S CONDITION WAS REPORTED TO BE "FINE" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTIFLEX¿ SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562402 0015124771

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention