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

Model Number M00546610

Device Problems Connection Problem (2900); Optical Problem (3001); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2020

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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used during a biopsy procedure performed in the bile duct on (b)(6) 2020.According to the complainant, during the procedure, the spyscope image disappeared.Reportedly, the connection part of the scope seemed unsteady even after the click/ lock sound was heard.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 biopsy procedure performed in the bile duct on (b)(6) 2020.According to the complainant, during the procedure, the spyscope image disappeared.Reportedly, the connection part of the scope seemed unsteady even after the click/lock sound was heard.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

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 visual evaluation noted that the catheter demonstrated signs of use in the form of elevator marks along the shaft.No damage was noted.Witness marks were observed on the contacts of the umbilicus connector, indicating it was connected to a controller.An image assesssment was performed.The device was plugged into the controller.No image was displayed.No issues were observed with the connection of the device, and manipulation of the connector did not result in a live image during analysis.The connector was fully held in place by the umbilicus locking tab and there was no notable movement of the umbilicus connector within the controller port.Real-time x-ray was used to image the distal tip, including the camera and wires.The x-ray showed no camera wire damage.In the handle, no damage was observed to the printed circuit board (pcb) or camera wires.It was noted that the wires or through-silicon vias (tsvs) appeared to have residue present, possibly from fluid ingress or corrosion.It is possible that fluid reached the redistribution layer (rdl) or tsv and as it dried, electrical properties of the connection point changed and resulted in the failure of the device.The reported event was confirmed.It is likely that the camera wires separated from the rdl, possibly due to mechanical forces applied to the camera wire as the device was assembled or the tip was articulated.Once the wires were separated, it was possible for corrosion to begin to take place in the gap formed between the wires and the rdl.This fluid can affect the electrical characteristics of the connection between the camera wires and rdl, increasing resistance and resulting in a loss of image.Evidence from x-ray inspection of the device suggests that fluid was likely present in the camera assembly during the procedure.It is likely that exposure to saline and/or procedural fluids shorted out the camera, causing the reported visualization issue and resulted in corrosion over time.An investigation has been completed to address visualization issues due to fluid ingress at the rdl.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: 10163793
• MDR Text Key: 195565923
• Report Number: 3005099803-2020-02344
• 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: 08/17/2020

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: 08/18/2020
• Device Model Number: M00546610
• Device Catalogue Number: 1759-02
• Device Lot Number: 0024291163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Manufacturer Received: 05/25/2020
• Initial Date FDA Received: 06/17/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1