MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS II ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00546610

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

Patient Problems Fever (1858); Perforation (2001); Pancreatitis (4481)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

Block b3 (date of event): date of event was approximated to (b)(6) 2023 as no event date was reported.Block d4, h4: the complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.Block h6 (patient codes): imdrf patient code (b)(6) captures the reportable event of pancreatitis.Imdrf patient code (b)(6) captures the reportable event of cholangitis.Imdrf patient code (b)(6) captures the reportable event of perforation.Imdrf patient code (b)(6) captures the reportable event of fever.Imdrf impact code (b)(6) captures the reportable event of serious injury.

Event Description

It was reported to boston scientific corporation that at the 105th annual meeting of the japanese society for gastrointestinal endoscopy (jges) a retrospective study of incident complications and their risk factors of 122 patients (75 males and 47 females, median age was 72 years) who underwent lithotripsy using a digital trans-oral biliary cholangioscopy for refractory bile duct stones from (b)(6) 2014 to (b)(6) 2022 was performed to complete stone removal.The spyscope ds ii was used for these procedures.The review found 35 out of 122 incidents (13 cases of cholangitis, 20 cases of next-day fever, 1 case of pancreatitis, and 1 case of perforation) all of which improved with conservative treatment.

• Brand Name: SPYSCOPE DS II ACCESS & DELIVERY CATHETER
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17172123
• MDR Text Key: 317633667
• Report Number: 3005099803-2023-03271
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/21/2023

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
• Device Model Number: M00546610
• Device Catalogue Number: 4661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2023
• Initial Date FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention