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

Model Number M00546610

Device Problems Poor Quality Image (1408); Material Integrity Problem (2978); Optical Problem (3001); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

Note: this report pertains to the first of two spyscope ds ii used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii was used in the common bile duct during a cholangioscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noticed that after flushing the common bile duct the image of the spyscope ds ii flickered and was lost approximately 45 minutes into the procedure.A second spyscope ds ii was used; however, the image also flickered and was lost approximately 30 minutes later.Reportedly, a seal leakage at the distal part was noted on the two spyscope ds ii devices.The procedure was not completed due to this event and will be rescheduled for (b)(6) 2020.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be ok.

Manufacturer Narrative

Block h6 (device codes): problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the returned spyscope ds ii was analyzed, and a visual evaluation noted that there were no elevator marks on the shaft of the catheter.No other damage was noted.Witness marks were observed on the contacts of the umbilicus connector, indicating it was connected to a controller.An image assessment was performed.Upon plugging the device into the controller, it displayed a live, clear image.No issues were identified with the image.No issues were observed with physical connectivity of the device.The device was fully articulated in all directions; no issues were identified with the image.Real-time x-ray was used to image the distal tip, including the through-silicon vias tsvs, redistribution layer (rdl), and camera wires.No damage was observed to the camera wires at or inside of the camera housing/cap.In the handle, no damage was observed to the printed circuit board (pcb).It was noted that the camera wires appeared possibly kinked near to where they enter the break out.The handle was opened and the connection of the camera wires to the pcba was inspected.No damage or defect was noted to the glue feature or the bond between the solder pads and the camera wires.The glue feature was wiggled with tweezers to test the solder bond of the wires, and no change to the image was noted.It did not appear that the camera wire was exposed, and articulation of the device could not cause the device to fail.The reported event was not confirmed.Product analysis was unable to replicate the failure or identify any issue that could have caused or contributed the reported event.Based on all gathered information, the probable root cause of this complaint is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii was used in the common bile duct during a cholangioscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noticed that after flushing the common bile duct the image of the spyscope ds ii flickered and was lost approximately 45 minutes into the procedure.A second spyscope ds ii was used, however, the image also flickered and was lost approximately 30 minutes later.Reportedly, a seal leakage at the distal part was noted on the two spyscope ds ii devices.The procedure was not completed due to this event and will be rescheduled for (b)(6), 2020.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be ok.

• 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
• MDR Report Key: 10303503
• MDR Text Key: 199886610
• Report Number: 3005099803-2020-02901
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/31/2020

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 Expiration Date: 03/06/2022
• Device Model Number: M00546610
• Device Catalogue Number: 1759-02
• Device Lot Number: 25320757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1