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 Problem Hemorrhage/Bleeding (1888)

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 e0506 captures the reportable event of hemorrhage.Imdrf patient code e1109 captures the reportable event of cholangitis.Imdrf impact code f12 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 review of 32 patients (male and female, median age 77 years (25-97) years) using electrohydraulic shock wave lithotripsy (ehl) under oral cholangioscopy (pocs) from (b)(6) 2016 to (b)(6) 2022 was performed with difficult-to-treat bile duct stones who were unable to undergo complete stone removal by conventional procedures.The spyscope ds ii was used for these procedures.The review found five cases of cholangitis and two cases of biliary hemorrhage; all cases were resolved 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: 17172611
• MDR Text Key: 317634713
• Report Number: 3005099803-2023-03280
• 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