BEUDAMED
    FDA Adverse Event Death Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1860364 · Received October 7, 2010

    Report

    Report Number
    3005099803-2010-04200
    Event Type
    Death
    Date Received
    October 7, 2010
    Date of Event
    August 4, 2010
    Report Date
    September 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN.(B)(4) - NO CODE AVAILABLE (INTERVENTION REQUIRED TO STOP BLEED).THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS STANDARD CAPACITY WAS USED DURING AN UPPER ENDOSCOPY ON A (B)(6) FEMALE PATIENT ON (B)(6) 2010 . THE INDICATION FOR THE BIOPSY WAS TO DIFFERENTIATE BETWEEN HEMORRHAGIC GASTRITIS AND GASTRIC ANTRAL VASCULAR ECTASIA (GAVE) . THE PATIENT HAD A PAST MEDICAL HISTORY OF COMPENSATED ALCOHOLIC LIVER CIRRHOSIS WITH SECONDARY THROMBOPENIA AND BARRETT'S ESOPHAGUS. AT THE TIME OF THE BIOPSY THE PATIENT'S PLATELET COUNT WAS "AROUND 50". ACCORDING TO THE COMPLAINANT, THE DEVICE WAS USED SUCCESSFULLY IN RETRIEVING TWO BIOPSY SAMPLES FROM THE PATIENT'S ANTRUM. THE DEVICE PERFORMED AS EXPECTED. THERE WAS NO BLEEDING AT THE BIOPSY SITES; HOWEVER, THERE WAS SLIGHT BLEEDING IN THE DUODENUM DUE TO THE PATIENT'S GAGGING. NO TREATMENT WAS REQUIRED FOR THIS BLEEDING. ON (B)(6) 2010, THE PATIENT PRESENTED TO THE HOSPITAL WITH SYMPTOMS OF BLEEDING, AND A SECOND ENDOSCOPY REVEALED THAT THERE WAS BLEEDING AT THE PREVIOUS BIOPSY SITES. THE BLEEDING WAS ATTEMPTED TO BE CONTROLLED WITH EPINEPHRINE INJECTIONS, PLACEMENT OF TWO HEMOCLIPS, AND A BLOOD TRANSFUSION, HOWEVER, THE PATIENT REQUIRED INTUBATION AND RESUSCITATION. AFTER THE PROCEDURE, THE PATIENT WAS ADMITTED TO THE ICU WHERE SHE LATER EXPERIENCED HEPATIC ENCEPHALOPATHY, KIDNEY FAILURE AND RESPIRATORY FAILURE. SHE SUBSEQUENTLY EXPIRED ON (B)(6) 2010. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 4 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00513402

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death