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 Perforation (2001)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

(date of event): the exact date of the event is unknown.The provided event date (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii was used in the bile duct during an endoscopic sphincterotomy (est) procedure performed on an unknown date.Reportedly, there were no issues noted with the spyscope ds ii during the procedure.According to the complainant, during the procedure, the area near the papillae was checked and a large perforation was observed in the nipple est area.Reportedly, the physician thinks that the papilla vater was small and the est cut was also small, so the perforation was probably caused as the spyscope ds ii was inserted into and removed from the papilla vater many times.Upon discovering the perforation, a clip was used immediately, endoscopic nasobiliary drainage (enbd) was placed, and an nasogastric tube was also placed.The patient's condition at the conclusion of the procedure was reported to be recovered.

• 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10791121
• MDR Text Key: 214751610
• Report Number: 3005099803-2020-05116
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/04/2020

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: 10/14/2020
• Initial Date FDA Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention