BEUDAMED
    FDA Adverse Event Death Summary report: N

    RADIAL JAW 4

    MDR report key: 9679665 · Received February 6, 2020

    Report

    Report Number
    3005099803-2020-00202
    Event Type
    Death
    Date Received
    February 6, 2020
    Date of Event
    January 3, 2020
    Report Date
    April 7, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    UDI-DI
    08714729792864
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H2: BLOCK B5 HAVE BEEN UPDATED BASED ON ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 07, 2020. BLOCK H10: ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. BLOCK H2: CORRECTION BLOCK B5: THE ORIGINAL EVENT DESCRIPTION FOR SUPPLEMENTAL-001 THAT WAS SENT ON MARCH 03, 2020 WAS EDITED IN ERROR. THE EVENT DESCRIPTION HAS BEEN CORRECTED TO THE ORIGINAL EVENT.

    Additional Manufacturer Narrative · 0

    BLOCK H2: BLOCK B5 HAVE BEEN UPDATED BASED ON ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 07, 2020. BLOCK H10: ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 PULMONARY BIOPSY FORCEPS WAS USED IN THE LUNGS DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS SUSPECTED TO HAVE A MALIGNANT TUMOR IN THE LUNG. DURING THE PROCEDURE, AFTER 12 BIOPSIES WERE TAKEN, THE PATIENT BEGAN TO BLEED. ICE WATER LAVAGE WAS USED TO SLOW THE BLEEDING AND THE SCOPE WAS REMOVED. THE PATIENT THEN BEGAN TO BLEED FROM THE NOSE AND MOUTH. THE PHYSICIAN WAS UNABLE TO RE-INTUBATE THE PATIENT. THE PATIENT WAS UNABLE TO BE RESUSCITATED. THE PATIENT EXPIRED AT APPROXIMATELY 12:30 ON (B)(6) 2020. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION RECEIVED FEBRUARY 07, 2020: THE BIOPSIES WERE TAKEN IN THE RIGHT UPPER LOBE. ACCORDING TO THE PHYSICIAN, THE PATIENT WAS EXPECTED TO BLEED DUE TO THE NATURE OF THE LESION, A MALIGNANCY. ADDITIONALLY, THE PHYSICIAN CONFIRMED THAT THERE WERE NO ISSUES WITH THE FORCEPS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 PULMONARY BIOPSY FORCEPS WAS USED IN THE LUNGS DURING A BRONCHOSCOPY WITH BIOPSY PROCEDURE PERFORMED ON (B)(6) 10, 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A BIOPSY WAS PERFORMED FOR A SUSPECTED MALIGNANT TUMOR. AFTER THE FIRST BIOPSY, THE SITE BEGAN TO BLEED. ICE WATER FLUSH WAS USED TO SLOW THE BLEEDING. A SECOND BIOPSY WAS THEN TAKEN AND MORE BLEEDING OCCURRED. ICE WATER FLUSHES WERE USED AGAIN. A RAPID RESPONSE TEAM WAS CALLED AND THE PATIENT WAS STABILIZED. THE PATIENT WAS THEN BROUGHT TO THE POST ANESTHESIA CARE UNIT AND WAS RELEASED FROM THE HOSPITAL ON THE SAME DAY. THERE WERE NO REPORTED ISSUES WITH THE DEVICE. ADDITIONAL INFORMATION RECEIVED FEBRUARY 07, 2020: THE BIOPSIES WERE TAKEN IN THE RIGHT UPPER LOBE. ACCORDING TO THE PHYSICIAN, THE PATIENT WAS EXPECTED TO BLEED DUE TO THE NATURE OF THE LESION, A MALIGNANCY. ADDITIONALLY, THE PHYSICIAN CONFIRMED THAT THERE WERE NO ISSUES WITH THE FORCEPS.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 PULMONARY BIOPSY FORCEPS WAS USED IN THE LUNGS DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS SUSPECTED TO HAVE A MALIGNANT TUMOR IN THE LUNG. DURING THE PROCEDURE, AFTER 12 BIOPSIES WERE TAKEN, THE PATIENT BEGAN TO BLEED. ICE WATER LAVAGE WAS USED TO SLOW THE BLEEDING AND THE SCOPE WAS REMOVED. THE PATIENT THEN BEGAN TO BLEED FROM THE NOSE AND MOUTH. THE PHYSICIAN WAS UNABLE TO RE-INTUBATE THE PATIENT. THE PATIENT WAS UNABLE TO BE RESUSCITATED. THE PATIENT EXPIRED AT APPROXIMATELY 12:30 ON (B)(6) 2020. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141221 RADIAL JAW 4 FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC CORPORATION M00515181 08714729792864

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death