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

Model Number M00546610

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2022

Event Type  malfunction  

Manufacturer Narrative

Physician phone number): (b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that a spyscope ds ii was used in the common bile duct during a cholangio-pancreatography retrograde endoscopic (cpre) with cholangioscopy procedure performed on (b)(6) 2022.During the procedure, the image from the spyscope ds ii was lost after ten minutes of usage.The physician decided to implant the stent and reschedule the procedure.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block e1 (physician phone number): dr.(b)(6).(b)(6) / (b)(6).Block h6 (impact codes): impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned spyscope ds ii was analyzed, and a visual evaluation was performed.Signs of use in the form of elevator marks were noted on the shaft of the catheter.Elevator marks measured from the tip.No damage was noted.Witness marks were observed on the contacts of the umbilicus connector, indicating it was connected to a controller.X-ray imaging of the distal tip showed no problems with the redistribution layer (rdl) or thru-silicon vias (tsvs).X-ray imaging of the handle showed no problems with the printed circuit board assembly (pcba) or camera wires.It was noted that the umbilicus connector was not seated in the umbilicus pcba in the connector.An image assessment for visualization was performed.The device was plugged into the controller and no image was displayed.The umbilicus of the device was replaced with a known working umbilicus and a live image was displayed.The original umbilicus of the complaint device was inspected.Visual inspection of the inside of the umbilicus housing showed that the umbilicus connector was not seated in the umbilicus pcba in the connector.The umbilicus connector cables were reconnected to the circuit board of the housing and upon insertion of the umbilicus into the controller, a live image was displayed.Calibration data was downloaded from the onboard memory to confirm that the unit had been properly calibrated and tested at the end of the production line.The reported event was confirmed.Product analysis found a disconnected wire in the umbilicus connector that caused the reported event.Manufacturing processes include the visual inspection of the umbilicus connector cable to ensure the umbilicus connector cable is properly connected to the pcba connection port in the umbilicus housing.Manufacturing processes also outline the calibration of the spyscope ds ii camera and the input of calibration data that allows for an image to properly be displayed.Because the camera work order and serial number was obtained during product analysis, it is likely that the device went through the proper steps of calibration and indicates the umbilicus connector cable was properly seated and connected to the pcba connection port in the umbilicus housing during manufacturing.Signs of use were seen during product analysis, indicating that the failure occurred during use.Procedural handling and internal forces caused by manipulation of the device may have caused the umbilicus connector cable to become loose during the procedure leading to a loss of visualization.Based on all gathered information, the complaint investigation conclusion code selected for the loss of visualization is cause traced to component failure, which states that a random component failure without any manufacturing issue can be attributed to the complaint.H11: block d4 (catalog number) has been corrected.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii was used in the common bile duct during a cholangio-pancreatography retrograde endoscopic (cpre) with cholangioscopy procedure performed on (b)(6) 2022.During the procedure, the image from the spyscope ds ii was lost after ten minutes of usage.The physician decided to implant the stent and reschedule the procedure.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

• 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: 16025449
• MDR Text Key: 308249309
• Report Number: 3005099803-2022-07455
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/02/2023

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
• Device Lot Number: 0030455190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 01/13/2023
• Supplement Dates FDA Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2022
• 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