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

Model Number M00546610

Device Problem Difficult to Advance (2920)

Patient Problem Inflammation (1932)

Event Date 08/18/2023

Event Type  Injury  

Manufacturer Narrative

Block h6 (patient codes): imdrf patient code e2326 captures the reportable event of inflammation.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used in the hilar stricture during an endoscopic retrograde cholangeopancreatography (ercp) with spyglass procedure performed on (b)(6) 2023.During the procedure, the accessory devices are having difficulty advancing through the spyscope ds ii and they could see it getting stuck on fluoroscopy at the tip of the spyscope ds ii.The guidewire was front-loaded successfully; however, they are having difficulty backloading it.A second spyscope ds ii was used without a problem in passing the accessory devices; however, the catheter could not cannulate due to the ampulla swelling to drive-up the bile duct.The procedure was completed using a cytology brush and a plastic stent was placed inside the patient to ensure proper bile duct drainage.Reportedly, it was found that the patient had a possible re-occurring cholangiocarcinoma post-surgery.The patient came back for a repeat procedure and received diagnosis.The patient's condition at the conclusion of the procedure was reported to be good.

• 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: 17744309
• MDR Text Key: 323385141
• Report Number: 3005099803-2023-04805
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2023

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
• Device Lot Number: 0031593046
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2023
• 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