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); Defective Device (2588); Device-Device Incompatibility (2919); Optical Problem (3001); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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 second of two spyscope ds ii access and delivery catheter devices used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access and delivery catheter was used in the common bile duct (cbd) during a cholangioscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, while they were in the common bile duct, the image of the spyscope ds ii flickered and disappeared during flushing.Reportedly, the visualization problem occurred approximately 30 minutes into the procedure.A second spyscope ds ii was used; however, the image also flickered and disappeared.Reportedly, water was coming in through the distal part of the two spyscope ds ii, and electrohydraulic lithotripsy (ehl) was performed when the visualization problems occurred.They attempted to reconnect the spyscope ds ii devices to the controller after the image was lost; however, the image was not restored.The procedure was not completed due to this event.

Manufacturer Narrative

Block h6 (device codes): problem code a27 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned spyscope ds ii access & delivery catheter was analyzed, and a visual evaluation noted that no elevator marks were noted along the shaft of the device.No damage was noted.Witness marks were observed on the contacts of the umbilicus connector, indicating it was connected to a controller.No other problems with the device were noted.An image assessment for visualization was performed.Upon plugging the device into the controller, a live image was displayed.The frame rate of the camera was measured, and was shown to be low, and resulted in a poor quality image.X-ray imaging of the distal tip showed no problem with the camera wire, redistribution layer (rdl), or thru-silicon vias (tsvs).X-ray imaging of the handle showed no problem with the printed circuit board assembly (pcba).The handle was opened and the solder pads were visually inspected.No damage or defect was noted to the glue feature or the solder pads.It was noted that the solder on one of the pins of the u2 voltage regulator had failed.When the component was manipulated with a wooden tool to apply pressure to the component, the image was lost.Image could be restored when pressure was applied to the lead to press it into the solder.It was noted that procedural residue was present in the breakout region in the handle.The tip was blocked and saline was flushed through the irrigation tubing to induce backflow of saline into the optics lumen.No change to the image was noted during this test.No leaks were observed in the fluidics tubing.The reported event was confirmed.Analysis found that the solder bond on one of the leads of a voltage regulator in the handle had failed, resulted in a poor electrical connection on the component.No leakage in the fluidics was observed during testing.The printed circuit board assembly in the handle is a supplied component, and the solder bond of the voltage regulator is controlled by that sub-vendor.Problems of supplied components are monitored, and no similar complaints were identified for the batch reported.Based on all gathered information, the probable cause selected for the visualization problem due to the problem with the voltage regulator 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.A search of the complaint database confirmed that no similar complaints exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/product label.

Event Description

Note: this report pertains to the second of two spyscope ds ii access and delivery catheter devices used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access and delivery catheter was used in the common bile duct (cbd) during a cholangioscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, while they were in the common bile duct, the image of the spyscope ds ii flickered and disappeared during flushing.Reportedly, the visualization problem occurred approximately 30 minutes into the procedure.A second spyscope ds ii was used; however, the image also flickered and disappeared.Reportedly, water was coming in through the distal part of the two spyscope ds ii, and electrohydraulic lithotripsy (ehl) was performed when the visualization problems occurred.They attempted to reconnect the spyscope ds ii devices to the controller after the image was lost; however, the image was not restored.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 event of aborted/cancelled procedure.Block h10: the device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem 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 second of two spyscope ds ii access and delivery catheter devices used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access and delivery catheter was used in the common bile duct (cbd) during a cholangioscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, while they were in the common bile duct, the image of the spyscope ds ii flickered and disappeared during flushing.Reportedly, the visualization problem occurred approximately 30 minutes into the procedure.A second spyscope ds ii was used; however, the image also flickered and disappeared.Reportedly, water was coming in through the distal part of the two spyscope ds ii, and electrohydraulic lithotripsy (ehl) was performed when the visualization problems occurred.They attempted to reconnect the spyscope ds ii devices to the controller after the image was lost; however, the image was not restored.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
• MDR Report Key: 11108888
• MDR Text Key: 225395338
• Report Number: 3005099803-2020-06495
• 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,Followup
• Report Date: 02/26/2021

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: 03/06/2022
• Device Model Number: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 0025320757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 01/08/2021; 02/09/2021
• Supplement Dates FDA Received: 01/13/2021; 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1