MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT MODEL D SINGLE-USE DUODENOSCOPE; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	M0054242CE1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/18/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that an exalt model d scope was used during an endoscopic retrograde cholangiopancreatography (ercp) on a 41-year-old female patient (b)(6), enrolled in the e7156 exalt d scope 02 study, on (b)(6) 2022.The patient was referred for ercp for the indication of obstructive jaundice.An abdominal sonar revealed choledocholithiasis, and an enlarged gallbladder containing gravel.The patient had a previous ercp done in 2013 but could not give accurate details of the findings.A plastic stent had been inserted at that time.However, the patient denied that a cholecystectomy was advised, and that the stent should have been removed within a few months.The ercp findings of that examination were not available.During the procedure, it was confirmed that a blocked stent was still in place.Multiple small stones and gravel were present in the common bile duct (cbd).Efforts to remove the stent with both the exalt scope and a reusable scope were unsuccessful, including the use of a grasping forceps.While the exalt scope was in use, a non-bsc balloon was used to dilate the papilla to 12 millimeters and the physician expected the stent to loosen.However, after deflating and removing the balloon, brisk bleeding ensued, and the opening of the papilla was obscured.Hemospray was applied to the area of the papilla.After resuscitation with fluids and blood, the patient was sent for an emergency computerized tomography (ct) angiography.At that time, the patient's hemoglobin (hb) was 12, and the patient was in a stable condition.The angiography showed a blush from the gastroduodenal artery (gda).The patient had a second severe bleed and interventional radiology was consulted; however, the patient's condition destabilized, and she was taken for emergency surgery.During surgery, a laparotomy was performed, the patient crashed, and cardiopulmonary resuscitation (cpr) was initiated.An anterolateral thoracotomy was performed, and internal cardiac massage was initiated.The patient was clamped, the bleeding was identified, and suture ligated.The patient's chest was closed with implantable cardioverted defibrillator (icd) in place.The abdomen was left open.The patient was hemodynamically and metabolically unstable on double inotropes.The patient was taken to the intensive care unit.Resuscitation was needed and a second massive transfusion protocol (mtp) was initiated.The patient was coagulopathic.The patient was then reported to be unstable but responding to resuscitation.On (b)(6) 2022 at 05:00 hours the patient arrested, cpr was initiated unsuccessfully.The patient was reported as deceased.The principal investigator (pi) at the site assessed this event as not related to use of the exalt model d scope.The relationship to the ercp was assessed as causal.The bleeding was detected during the procedure with exalt model d scope.

• Brand Name: EXALT MODEL D SINGLE-USE DUODENOSCOPE
• Common Device Name: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15798891
• Report Number: 3005099803-2022-06696
• Device Sequence Number: 20022237
• Product Code: FDT
• UDI-Device Identifier: 08714729995753
• UDI-Public: 08714729995753
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K193202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/11/2024
• Device Model Number: M0054242CE1
• Device Catalogue Number: 4242CE
• Device Lot Number: 0028661108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 41 YR
• Patient Sex: Female