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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

Event Type  malfunction  

Event Description

Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-01247 for the first trapezoid basket, 3005099803-2024-01248 for the second trapezoid basket, and 3005099803-2024-01269 for the spyscope it was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used during an endoscopic retrograde cholangiopancreatography (ercp) cholangioscopy procedure performed for complex stone removal in the bile duct on (b)(6) 2024.During the procedure, the spyscope appeared to be working but the autolith touch ehl probe would not advance through the scope.After two attempts, a third ehl probe was positioned but would not fire.The machine was on, but a current wasnt delivered.The physician then reached for a trapezoid basket which split down the middle.A second basket was introduced, and it split as well.The procedure was not completed due to this event.Upon further inspection after the procedure was cancelled, it was determined that the ehl machine was functioning as intended and the ehl probes likely experienced resistance due to angulation at the elevator.Close observation of the probes showed kinks that were incurred during the advancement of the probes.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.

• 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: 18980358
• MDR Text Key: 338622408
• Report Number: 3005099803-2024-01269
• 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: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 0033409165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2024
• 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