MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DISCOVER DIGITAL CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	M00546780
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); Biliary Leak (4820)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a spyglass discover digital catheter along with accessories were used in the laparoscopic common bile duct exploration (lcbde) during a cholecystectomy procedure on (b)(6) 2024.When the patient had a cholecystectomy with an intraoperative cholangiogram (ioc) in the laparoscopic common bile duct exploration (lcbde) on (b)(6) 2024.The physician reported the patient presented with bile duct leak on ct scan.On (b)(6) 2024, the patient was scheduled for an ercp follow up for a medical intervention.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: patient code a24 captures the reportable event of bile duct leakage.
Event or Problem Description
It was reported to boston scientific corporation that a spyglass discover digital catheter along with accessories were used in the laparoscopic common bile duct exploration (lcbde) during a cholecystectomy procedure on (b)(6) 2024.When the patient had a cholecystectomy with an intraoperative cholangiogram (ioc) in the laparoscopic common bile duct exploration (lcbde) on (b)(6) 2024.The physician reported the patient presented with bile duct leak on ct scan.On (b)(6) 2024, the patient was scheduled for an ercp follow up for a medical intervention.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: patient code a24 captures the reportable event of bile duct leakage.Block h11: correction: block h6 patient code has been corrected.

• Brand Name: SPYGLASS DISCOVER DIGITAL CATHETER
• Common Device Name: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19601754
• Report Number: 3005099803-2024-02951
• Device Sequence Number: 17712741
• Product Code: FBN
• UDI-Device Identifier: 08714729994183
• UDI-Public: 08714729994183
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K200483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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 Model Number: M00546780
• Device Catalogue Number: 4678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Female
• Patient Race: Black Or African American