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 06/14/2023

Event Type  malfunction  

Manufacturer Narrative

Block d4, h4: the complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of absence of treatment.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used during a procedure performed on (b)(6) 2023.During the procedure, the spyscope ds ii was having difficulty advancing through the duodenoscope.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used during a procedure performed on (b)(6) 2023.During the procedure, the spyscope ds ii was having difficulty advancing through the duodenoscope.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.Additional information was received on july 21, 2023: it was reported that the re-procedure was performed on june 16th and was completed using another lot of the same product.

Manufacturer Narrative

Additional information: h6 (impact code) imdrf impact code f05 is being used to capture the reportable event of aborted/cancelled procedure.Block d4, h4: the complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.Block h10: the returned spyscope ds ii was analyzed, and a visual evaluation noted that there were signs of use in the form of elevator marks along the shaft of the catheter.No damage or defect was noted on the tip of the device or the working channel.Witness marks were observed on the contacts of the umbilicus connector, indicating it was connected to a controller.A functional assessment of accessory passability was performed.Testing was conducted with an autolith ehl probe.First, the spyscope was introduced into an articulation fixture to test for passability, no problems were observed and the spyscope passed freely.The ehl probe was passed through the spyscope in a straight configuration, but difficulty was observed.It felt restricted and took more force to pass than expected.The probe was removed from the device with no problem observed.The spyscope device was placed in an articulation fixture and a functional assessment was repeated by passing the ehl probe through the device.The ehl probe would not pass through the tip.A borescope was used to perform visual inspection inside the working channel lumen.It was noted that the wall of the working channel lumen appeared collapsed just proximal to the working channel sleeve.The device was dissected by cutting the shaft in half to further visualize the lumen deformation, and it was confirmed that the lumen appeared deformed proximal to the steering ring.The reported complaint was confirmed.Product analysis found the working channel lumen was deformed at the tip.It is likely that this is a random problem of the component and is unlikely related to a manufacturing problem.Based on all gathered information, the complaint investigation conclusion code selected for the accessory problem is cause traced to component failure, which indicates that the failure is an expected or random component problem with no design or manufacturing elements.

• 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: 17317597
• MDR Text Key: 319678163
• Report Number: 3005099803-2023-03601
• 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: 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,Followup
• Report Date: 08/14/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 07/21/2023
• Supplement Dates FDA Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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