BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXALT MODEL D SINGLE-USE DUODENOSCOPE

    MDR report key: 11379782 · Received February 25, 2021

    Report

    Report Number
    3005099803-2021-00703
    Event Type
    Injury
    Date Received
    February 25, 2021
    Date of Event
    January 19, 2021
    Report Date
    February 25, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDT
    UDI-DI
    08714729983514
    PMA / PMN Number
    K193202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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). 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.

    Description of Event or Problem · 1

    ON (B)(6) 2021 IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT, DURING USE OF AN EXALT MODEL D SINGLE-USE DUODENOSCOPE TO PERFORM AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR MANAGEMENT OF POST-SPHINCTEROTOMY BLEEDING, A PATIENT SUSTAINED AN ESOPHAGEAL PERFORATION. THE PATIENT HAD UNDERGONE TWO PRIOR ERCP PROCEDURES DURING THEIR HOSPITALIZATION FOR MANAGEMENT OF CHOLEDOCHOLITHIASIS AND CHOLANGITIS - BOTH USING A REUSABLE DUODENOSCOPE. THE FIRST WAS UNSUCCESSFUL AT GAINING ACCESS TO THE BILE DUCT. THE SECOND WAS SUCCESSFUL IN GAINING ACCESS AND A SPHINCTEROTOMY AND BALLOON EXTRACTION WAS DONE. AT SOME POINT AFTER THIS PROCEDURE THE PATIENT DEVELOPED EVIDENCE OF BLEEDING AND A REPEAT ERCP USING AN EXALT MODEL D SINGLE-USE DUODENOSCOPE WAS PLANNED. FOR THE PROCEDURE, THE PATIENT WAS INTUBATED AND IN SUPINE POSITION. REPORTEDLY, NO RESISTANCE WAS FELT WHEN PASSING THE SCOPE DOWN THE DISTAL ESOPHAGUS OR ACROSS THE GASTRO-ESOPHAGEAL JUNCTION (GEJ). HOWEVER, THE PHYSICIAN DID ENCOUNTER A "J-SHAPED" STOMACH WHICH CAUSED DIFFICULTY WITH LOOPING OF THE SCOPE IN THE STOMACH AND KEPT HIM FROM TRAVERSING THE PYLORUS. TO MANAGE THIS, THE ENDOSCOPIST REPEATEDLY PULLED BACK AND RE-ADVANCED THE ENDOSCOPE IN THE STOMACH. DURING THIS PROCESS HE NOTICED SOMETHING IN THE AREA OF THE GEJ THAT "DID NOT LOOK RIGHT." AS A RESULT, HE REMOVED THE EXALT D SCOPE AND PERFORMED AN UPPER ENDOSCOPY WITH A REUSABLE GASTROSCOPE. THIS REVEALED WHAT APPEARED TO BE A FULL-THICKNESS PERFORATION, APPROXIMATELY 1.5CM PROXIMAL TO THE GEJ ON THE LEFT POSTERIOR WALL OF THE ESOPHAGUS ("7 O'CLOCK" POSITION). SUBCUTANEOUS CREPITUS FELT IN THE PATIENT'S NECK SUPPORTED THE PHYSICIAN'S ASSESSMENT THAT THERE WAS A FULL-THICKNESS INJURY. HE CLOSED THE INJURY WITH BOSTON SCIENTIFIC RESOLUTION CLIPS. AFTER CLOSURE HE REMOVED THE GASTROSCOPE AND RE-INTRODUCED THE SAME EXALT D SCOPE TO COMPLETE THE ERCP. HE WAS ABLE TO SUCCESSFULLY PASS THE EXALT D INTO THE DUODENUM AND DOES NOT REMEMBER MUCH STOMACH LOOPING ON THE SECOND PASSAGE. ON INSPECTION OF THE PAPILLA, THERE WAS ACTIVE BLEEDING AT THE SPHINCTEROTOMY SITE WITHOUT EVIDENCE OF PERFORATION. A SELF-EXPANDING METAL BILIARY STENT WAS PLACED TO STOP THE BLEEDING. HE THEN REMOVED THE EXALT D SCOPE AND PERFORMED A REPEAT UPPER ENDOSCOPY WITH THE GASTROSCOPE. THE CLIP CLOSURE OF THE ESOPHAGUS WAS STILL INTACT WITH NO DISRUPTION. HE THEN PLACED A SELF-EXPANDING METAL ESOPHAGEAL STENT TO COVER THE AREA. AFTER THE PROCEDURE, THE PATIENT WAS HEMODYNAMICALLY STABLE AND THE SUBCUTANEOUS NECK CREPITUS RESOLVED. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) INTUBATED, A THORACIC SURGERY CONSULT WAS OBTAINED, AND A COMPUTERIZED TOMOGRAPHY (CT) SCAN OF THE CHEST AND ABDOMEN WAS PERFORMED. THE PHYSICIAN STATED THAT THE CT SCAN SHOWED NO EVIDENCE OF PNEUMOMEDIASTINUM, A SLIGHT AMOUNT OF SUBCUTANEOUS GAS, AND A SMALL RIGHT SIDED PLEURAL EFFUSION. THE THORACIC SURGERY TEAM PLACED A CHEST TUBE TO DRAIN THE EFFUSION. THE PATIENT RECOVERED IN THE ICU, WAS EXTUBATED, HAD THE CHEST TUBE REMOVED, AND WAS SCHEDULED FOR AN ESOPHAGRAM IN PREPARATION FOR INITIATING ORAL FEEDING. THE PHYSICIAN STATED THAT HE DOES NOT THINK THE SHAFT STIFFNESS CAUSED THE EXALT D PERFORATION AS REINTRODUCTION OF EXALT D AFTER THE CLIP CLOSURE OF THE ESOPHAGEAL PERFORATION DID NOT EXERT SIGNIFICANT LATERAL FORCE ON THE ESOPHAGEAL WALL AS EVIDENCED BY THE PERSISTENTLY INTACT CLIP CLOSURE. HE ALSO THINKS THAT A STIFFER SHAFT RESULTS IN LESS LOOPING IN THE STOMACH AND THAT THE LOCATION OF THE PERFORATION ABOVE THE GEJ IS NOT CONSISTENT WITH A STIFF SHAFT EXERTING HIGH "BOWING PRESSURES." REPORTEDLY, THE PATIENT HAD A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278837 EXALT MODEL D SINGLE-USE DUODENOSCOPE DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT BOSTON SCIENTIFIC CORPORATION M00542420 08714729983514

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Required Intervention