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 Pneumonia (2011); Peritonitis (2252); Pancreatitis (4481)

Event Date 05/01/2023

Event Type  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 73 procedures in 50 patients (28 males, median age 78 (36-94) years) who underwent electrohydraulic shock wave choledochal-lithotripsy (ehl) using an oral biliary cholangioscopy from april 2017 to september 2022 was performed for bile duct stones that are difficult to remove even with mechanical lithotripsy.The purpose of this study was to review the results of treatment and to clarify its usefulness.The spyscope ds ii was used for these procedures.The review found twelve cases of mild cholangitis, two cases of mild pancreatitis, one case of moderate peritonitis, and one case of mild aspiration pneumonia.Of these cases, one case had both cholangitis and pancreatitis.All cases were treated conservatively.

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 e1024 captures the reportable event of peritonitis.Imdrf patient code e1109 captures the reportable event of cholangitis.Imdrf patient code e0733 captures the reportable event of pancreatitis.Imdrf patient code e0733 captures the reportable event of pneumonia.Imdrf impact code f12 captures the reportable event of serious injury.

• 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: 17174281
• MDR Text Key: 317631526
• Report Number: 3005099803-2023-03306
• 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