BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX LOCKING DEVICE AND BIOPSY CAP

    MDR report key: 12258685 · Received August 2, 2021

    Report

    Report Number
    3005099803-2021-03917
    Event Type
    Malfunction
    Date Received
    August 2, 2021
    Date of Event
    July 14, 2021
    Report Date
    September 20, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ODC
    UDI-DI
    08714729296614
    PMA / PMN Number
    K010610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: PROBLEM CODE A0501 CAPTURES THE REPORTABLE EVENT OF SPONGE DETACHMENT. BLOCK H10: ONE BIOPSY CAP WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION SHOWED THAT THE SPONGE WAS RETURNED INSIDE OF THE BIOPSY CAP AND THERE WERE NO VISIBLE ISSUES. FUNCTIONAL TEST WAS PERFORMED BY PASSING THROUGH AN AUTOTOME IN THE BIOPSY CAP AND IT COULD PASSED OR WITHDRAWN WITHOUT PROBLEMS. BASED ON INFORMATION AVAILABLE AND THE ANALYSIS PERFORMED IT WAS DETERMINED THAT THE BIOPSY CAP RETURNED WITH THE SPONGE INSIDE OF IT, FUNCTIONAL INSPECTION WAS PERFORMED BY PASSING AND WITHDRAWING AN AUTOTOME LABORATORY TEST UNIT TROUGH THE BIOPSY CAP, NO PROBLEMS WERE PRESENTED. THEREFORE, THE REPORTED PROBLEM OF SPONGE DETACHMENT COULD NOT BE CONFIRMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX LOCKING / BIOPSY CAP WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN PASSING A SPHINCTEROTOME, THE SPONGE GOT DETACHED AND GOT STUCK INSIDE THE SCOPE. THE SPONGED WAS REMOVED WITH A BIOPSY FORCEP. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX LOCKING / BIOPSY CAP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX LOCKING / BIOPSY CAP WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN PASSING A SPHINCTEROTOME, THE SPONGE GOT DETACHED AND GOT STUCK INSIDE THE SCOPE. THE SPONGED WAS REMOVED WITH A BIOPSY FORCEP. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX LOCKING / BIOPSY CAP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157458 RX LOCKING DEVICE AND BIOPSY CAP ENDOSCOPE CHANNEL ACCESSORY ODC BOSTON SCIENTIFIC CORPORATION M00545261 0027368767 08714729296614

    Patients

    Seq Age Sex Outcome Treatment
    1