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

Model Number M00546610

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(6).(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 mdr will be filed.

Event Description

Note: this report pertains to a spyscope ds ii access and delivery catheter and a spyglass ds controller that were used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access and delivery catheter was used with a spyglass ds controller during a bile duct drainage procedure performed in the common bile duct on (b)(6) 2020.According to the complainant, during the procedure, while performing angle manipulation, the image of the spyscope ds ii disappeared about 20 minutes into the procedure.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.Block e1 (initial reporter city): (b)(6).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.No elevator marks were noted on the working length 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.The device was connected to a console and no image resulted.X-ray imaging of the distal tip showed a cloudy appearance of the redistribution layer (rdl) and camera wire.Xray imaging of the handle showed no damage to printed circuit board assembly (pcba) or camera wires.The reported event was confirmed.It is likely that the camera wires separated from the redistribution layer (rdl), due to mechanical forces applied to the camera wire as the device was assembled or as the tip was articulated during use.Once saline and other moisture was introduced into this area the electrical characteristics of the connection between the camera wires and rdl were affected, which resulted in the reported loss of image.An investigation to address this problem has been completed.As a result of the investigation, a hydrophobic coating has been added to the camera and process changes to address epoxy pot life and the camera tacking step.Based on all gathered information, the probable cause selected for the visualization problem due to camera wire damage from fluid ingress and possible corrosion is cause traced to device design, which indicates that problems were traced to the design specifications.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr history review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.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 access and delivery catheter and a spyglass ds controller that were used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access and delivery catheter was used with a spyglass ds controller during a bile duct drainage procedure performed in the common bile duct on (b)(6) 2020.According to the complainant, during the procedure, while performing angle manipulation, the image of the spyscope ds ii disappeared about 20 minutes into the procedure.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: 11065275
• MDR Text Key: 226301020
• Report Number: 3005099803-2020-06316
• 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: 01/19/2021

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 Model Number: M00546610
• Device Catalogue Number: 4661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 01/12/2021
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1