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

Model Number M00546610

Device Problems Positioning Problem (3009); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2020

Event Type  malfunction  

Manufacturer Narrative

(date of event): the exact date of the event is unknown.The provided event date (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Note: this report pertains to two spyscope ds ii and a spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii and a spyglass ds controller were used during a procedure performed on an unknown date.According to the complainant, during the procedure, the image of the spyscope ds ii was lost.A second spyscope ds ii was used; however, it could not be bent even if the handle was turned.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Event Description

Note: this report pertains to two spyscope ds ii and a spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii and a spyglass ds controller were used during a procedure performed on an unknown date.According to the complainant, during the procedure, the image of the spyscope ds ii was lost.A second spyscope ds ii was used; however, it could not be bent even if the handle was turned.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Correction - block d4 (catalog number): corrected from 1759-02 to 4661.Correction - block g5 (premarket / 510(k) #): corrected from k142922 to k181439.Block b3 (date of event): the exact date of the event is unknown.The provided event date (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6 (device codes): problem code 3191 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.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.Articulation was tested and was found to function as expected.No problems with articulation were noted.An image assessment was performed.The device was plugged into the controller.No image was displayed.Real-time x-ray was used to image the distal tip, including the camera and wires.The x-ray showed no camera wire damage at the camera on the distal tip.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 problem 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 problem and resulted in corrosion over time.An investigation is in place to address this problem.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

• 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: 10573153
• MDR Text Key: 208114794
• Report Number: 3005099803-2020-04142
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• PMA/PMN Number: K181439
• 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: 11/09/2020

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: 01/07/2022
• Device Model Number: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 0025009264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 10/18/2020
• Supplement Dates FDA Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1