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 Pancreatitis (4481)

Event Date 07/23/2021

Event Type  Injury  

Manufacturer Narrative

Note: the physician was present during the ercp procedure.Physician's full name: (b)(6).(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem 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 access & delivery catheter was used in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021 as part of (b)(6).Prior to study procedure for pancreatitis, a prophylactic antibiotics and indomethacin was given to the patient.Standard cannulation techniques were performed using sphincterotome and guidewire.Brief fluoroscopy was used to confirm biliary success.A spyscope ds ii catheter was used and the image was excellent.Biliary sphincterotomy was performed along with papillary balloon dilation with a 12mm balloon.One biliary stone was removed using the balloon and spyglass retrieval basket.Stone and sludge clearance was achieved and procedure was completed with the spyscope dsii.On (b)(6) 2021, the patient presented with post-ercp pancreatitis.The patient was hospitalized and medication was given with analgesics and anti-emetics.The patient was reported to be recovering.

• 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: 12392873
• MDR Text Key: 268968133
• Report Number: 3005099803-2021-04500
• 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: K181439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/31/2021

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 Expiration Date: 09/24/2022
• Device Model Number: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 0026073317
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 39 YR