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

Model Number M00546610

Device Problems Device-Device Incompatibility (2919); Compatibility Problem (2960); Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2022

Event Type  malfunction  

Event Description

Note: this report pertains to a spyscope ds ii and spy ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii and spyglass ds controller were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the image of the spyscope ds ii was not displayed one to two minutes after it was inserted into the bile duct.The screen repeatedly turned gray and dotted, and there were repeated disruptions while performing electrohydraulic lithotripsy (ehl).The spyscope ds ii was removed and reinserted back into the controller, the power was turned off and on again; however, the problem persisted.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

Block h6 (impact codes): impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: investigation results the returned spyscope ds ii was analyzed, and a visual evaluation noted that there were no elevator marks observed.An image test for the alleged visualization issue was performed by connecting the device to a controller: no image was displayed, only the 5-dot initialization screen.Reinsertion of the device into the controller did not yield an image.The handle was fully articulated in all directions; no impact to image was observed.X-ray imaging of the distal end showed no problems with the camera wires or the soldering at the redistribution layer (rdl).No camera wire damage was noted at the distal end.No problems with the camera wire in the pebax region.X-ray imaging of the handle showed camera wires potentially in contact at the glue feature.No problems with the camera wires around the strain relief or the breakout region were seen in x-ray imaging.The handle was opened and the electrical components inside were inspected visually.There was procedural residue seen in the plastic optic fibers (pof).Visual assessment confirmed camera wires were in contact at the glue feature.The bond of the glue feature to the printed circuit board assembly (pcba) was inspected; tweezers were used to wiggle the glue feature.The connection of the camera wires to the pcba was also inspected by slightly lifting the bottom of the glue feature for each of the four camera wires using the tip of the tweezers.No impact to image was seen after these interactions.Tweezers were used to manually separate the camera wires at the glue feature; however, doing so caused damage to the camera wires and image could not be restored.The reported complaint was confirmed.During x-ray assessment, camera wires at the glue feature were shown to potentially be in contact.Upon initial insertion of the device, there was no live image.Reinsertion of the device and articulation of the handle did not yield an image.Visual assessment of the glue feature confirmed that camera wires were in contact.A live image could not be displayed due to camera wire damage caused during analysis.The condition of the returned device suggests that the wires were touching as part of the manufacturing process, as the glue that covers them was fully cured.The camera wires separated from the glue feature and migrated to touch during transport/handling.Based on all gathered information, the most probable root cause for the visualization issue due to camera wires touching is manufacturing deficiency, which indicates that problems were traced to the manufacturing process.A search of the complaint database confirmed that no similar complaint exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

Note: this report pertains to a spyscope ds ii and spy ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii and spyglass ds controller were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the image of the spyscope ds ii was not displayed one to two minutes after it was inserted into the bile duct.The screen repeatedly turned gray and dotted, and there were repeated disruptions while performing electrohydraulic lithotripsy (ehl).The spyscope ds ii was removed and reinserted back into the controller, the power was turned off and on again; however, the problem persisted.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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15316772
• MDR Text Key: 305247389
• Report Number: 3005099803-2022-04774
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K181439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2022

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: 04/28/2024
• Device Model Number: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 0029314027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1