MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DISCOVER DIGITAL CATHETER

Model Number M00546780

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 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

(pro code): ntn.(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

This report pertains to the first of two spyglass discover digital catheter devices used during the same procedure.It was reported to boston scientific corporation that a spyglass discover digital catheter was used during a stone extraction procedure in the gallbladder performed on (b)(6) 2020.According to the complainant, during the procedure, the image of the spyglass discover catheter was lost and could not start the case.A second spy discover catheter was used; however, the image was also lost approximately 30 minutes into the procedure during stone removal.Reportedly, during set up, both catheters would not connect correctly.Reportedly, the connection ports were not clicking in correctly.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 the first of two spyglass discover digital catheter devices used during the same procedure.It was reported to boston scientific corporation that a spyglass discover digital catheter was used during a stone extraction procedure in the gallbladder performed on (b)(6) 2020.According to the complainant, during the procedure, the image of the spyglass discover catheter was lost and could not start the case.A second spy discover catheter was used; however, the image was also lost approximately 30 minutes into the procedure during stone removal.Reportedly, during set up, both catheters would not connect correctly.Reportedly, the connection ports were not clicking in correctly.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block d2 (pro code): ntn.Block h6 (device codes): problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the returned spyglass discover digital catheter was analyzed, and a visual evaluation was performed.No forcep marks were noted on the shaft of the catheter.No 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.The device was plugged into the controller.A live, clear image was displayed.No issues were observed in connecting the device to the controller.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 assembly (pcba).The camera wire was noted as suspicious in the breakout region.The handle was opened and the components within were visually inspected.The camera wire jacket covering the camera wires in the region of the breakout was damaged and the camera wire was exposed.With a live image displayed on the controller, a jumper wire was clipped to ground on one end and grazed the camera wire where the jacket was compromised on the other end.The image was disrupted.It's likely that the steering wire could similarly graze the camera wire and disrupt the image during a procedure when the device was being articulated.The reported event was confirmed.The breakout region of the handle is the routing location for the camera wire, plastic optical fibers (pofs), and steering wires as those components exit the handle.Articulation of the device during procedure causes movement of all of these components in the region.It is possible in this dynamic setting that the camera wire can interact with the steering wires, pofs, or the edges of the breakout.The forces exerted on the camera wires during this interaction have been found to damage the jacket or the conductors within.If the jacket is compromised, the wires are no longer insulated and can come into contact with the steering wires, resulting in an electrical short that will cause the image to turn off if the camera wires are damaged, this results in an electrical open that will cause the image to turn off.An investigation is underway to address visualization issues due to camera wire damage or jacket damage in the breakout region in the handle.Based on all gathered information, the most probable cause selected for the visualization issue due to camera wire or jacket damage in the breakout region is cause traced to component failure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Manufacturer Narrative

Block d2 (pro code): ntn block h6 (device codes): problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the returned spyglass discover digital catheter was analyzed, and a visual evaluation was performed.No forcep marks were noted on the shaft of the catheter.No 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.The device was plugged into the controller.A live, clear image was displayed.No issues were observed in connecting the device to the controller.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 assembly (pcba).The camera wire was noted as suspicious in the breakout region.The handle was opened and the components within were visually inspected.The camera wire jacket covering the camera wires in the region of the breakout was damaged and the camera wire was exposed.With a live image displayed on the controller, a jumper wire was clipped to ground on one end and grazed the camera wire where the jacket was compromised on the other end.The image was disrupted.It's likely that the steering wire could similarly graze the camera wire and disrupt the image during a procedure when the device was being articulated.The reported event was confirmed.The breakout region of the handle is the routing location for the camera wire, plastic optical fibers (pofs), and steering wires as those components exit the handle.Articulation of the device during procedure causes movement of all of these components in the region.It is possible in this dynamic setting that the camera wire can interact with the steering wires, pofs, or the edges of the breakout.The forces exerted on the camera wires during this interaction have been found to damage the jacket or the conductors within.If the jacket is compromised, the wires are no longer insulated and can come into contact with the steering wires, resulting in an electrical short that will cause the image to turn off if the camera wires are damaged, this results in an electrical open that will cause the image to turn off.An investigation is underway to address visualization issues due to camera wire damage or jacket damage in the breakout region in the handle.Based on all gathered information, the most probable cause selected for the visualization issue due to camera wire or jacket damage in the breakout region is cause traced to component failure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Block h11: correction: block g5 (premarket / 510(k) #) has been corrected.

Event Description

Note: this report pertains to the first of two spyglass discover digital catheter devices used during the same procedure.It was reported to boston scientific corporation that a spyglass discover digital catheter was used during a stone extraction procedure in the gallbladder performed on (b)(6) 2020.According to the complainant, during the procedure, the image of the spyglass discover catheter was lost and could not start the case.A second spy discover catheter was used; however, the image was also lost approximately 30 minutes into the procedure during stone removal.Reportedly, during set up, both catheters would not connect correctly.Reportedly, the connection ports were not clicking in correctly.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

• Brand Name: SPYGLASS DISCOVER DIGITAL CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10513391
• MDR Text Key: 219499384
• Report Number: 3005099803-2020-03852
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729994183
• UDI-Public: 08714729994183
• Combination Product (y/n): N
• PMA/PMN Number: K200483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2021

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: 06/16/2022
• Device Model Number: M00546780
• Device Catalogue Number: 4678
• Device Lot Number: 0025603009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 09/21/2020; 01/04/2021
• Supplement Dates FDA Received: 10/15/2020; 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1