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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Dehydration (1807); Fever (1858); High Blood Pressure/ Hypertension (1908); Pancreatitis (4481)

Event Date 09/14/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an exalt model d single use duodenoscope was used during an endoscopic retrograde cholangiopancreatography (ercp) on a 77-year-old female patient ((b)(6)), enrolled in the exalt d scope 02 study on (b)(6) 2022.The procedure was successfully completed and there were no device malfunctions reported.The patient was subsequently diagnosed with acute pancreatitis with on onset date of (b)(6) 2022.The patient was hospitalized from (b)(6) 2022 and treated with fluids and pain medication.The severity of the pancreatitis was reported to be mild.The principal investigator (pi) assessed the pancreatitis as having a causal relationship to the ercp and a possible relationship to the exalt model d scope.

Manufacturer Narrative

The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(report source): e7156 exalt dscope 02 clinical study.(b)(4).

Manufacturer Narrative

Block h6: the following patient codes were added based on additional information: e2326,e230101,e1201,e1002,e2320.Block b5, b6: based on additional information the patient presented additional symptoms and had a culture test which came out negative.Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block g2 (report source): e7156 exalt dscope 02 clinical study.Block h6 (patient codes): patient code e1021 captures the reportable event of pancreatitis requiring hospitalization.

Event Description

It was reported to boston scientific corporation that an exalt model d single use duodenoscope was used during an endoscopic retrograde cholangiopancreatography (ercp) on a 77-year-old female patient (b)(6) , enrolled in the exalt d scope 02 study on september 14, 2022.The procedure was successfully completed and there were no device malfunctions reported.The patient was subsequently diagnosed with acute pancreatitis with on onset date of (b)(6) 2022.The patient was hospitalized from (b)(6) 2022 and treated with fluids and pain medication.The severity of the pancreatitis was reported to be mild.The principal investigator (pi) assessed the pancreatitis as having a causal relationship to the ercp and a possible relationship to the exalt model d scope.Additional information received on november 30, 2022.A biopsy of pancreatic head mass was performed during the ecrp on (b)(6) 2022.The patient was diagnosed with adenocarcinoma.The patient presented to the emergency department on (b)(6) 2022 with progressive epigastric abdominal pain, low grade fevers, elevated blood pressure, and dehydration, subsequently the patient was diagnosed with acute pancreatitis, with an onset date of (b)(6) 2022.Ct of the abdomen showed new fat stranding around pancreatic head, pancreaticoduodenal groove and adjacent to the proximal duodenum extending into the region of the gallbladder fossa suggests either worsening acute pancreatitis and/or duodenitis.The patient was hospitalized from (b)(6) 2022 and treated with fluids and pain medication.The patients blood pressure was elevated while in the hospital and they received hydralazine as needed.The severity of the pancreatitis was reported to be mild.The patient was discharged home on (b)(6) 2022 in stable condition.The patient was instructed to follow up with oncology and have resection after pancreatitis clears fully.The principal investigator (pi) reassessed the pancreatitis as having a causal relationship to the ercp and as not related to the exalt model d scope.

• Brand Name: EXALT MODEL D SINGLE USE DUODENOSCOPE - CLINICAL
• Type of Device: 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: 15822816
• MDR Text Key: 303899614
• Report Number: 3005099803-2022-06527
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2022
• Initial Date FDA Received: 11/18/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female