MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANIX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00532290
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	02/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model d single-use duodenoscope, an extractor balloon, a truetome, and 2 advanix biliary stents were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the duodenum on (b)(6) 2021 as part of the exalt d scope 01b clinical study.There were no reported malfunctions associated with the exalt scope, extractor balloon, truetome, or advanix biliary stents.The patient had a medical history of current immunosuppression (pharmacologically induced) due to post-liver transplant, documented biliary or pancreatic stricture, abnormal imaging finding of an anastomotic stricture and "kink" in previously placed non-bsc biliary stent, 2 previous ercps, prior biliary sphincterotomy (major papilla), prior stent placement, and liver transplantation.On (b)(6) 2021, the patient experienced an adverse event of possible cholangitis and a fever with some increase in white count as a symptom of the cholangitis.As a result, the patient was hospitalized on (b)(6) 2021.The fever came down quickly after treatment.The patient was treated with zosyn iv x 2 days; cipro/flagyl as outpatient.Blood cultures were ordered and came back negative.The possible cholangitis was resolved on (b)(6) 2021 and the patient was discharged on (b)(6) 2021.The exalt scope, extractor balloon, truetome, and advanix biliary stents were reported to be unlikely related to the patient's possible cholangitis.The possible cholangitis was reported as possibly related to the ercp.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11519767
• Report Number: 3005099803-2021-01111
• Device Sequence Number: 14465478
• Product Code: FGE
• UDI-Device Identifier: 08714729787051
• UDI-Public: 08714729787051
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/04/2022
• Device Model Number: M00532290
• Device Catalogue Number: 3229
• Device Lot Number: 0025164246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/18/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 54 YR