MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	M00546600
Medical Device Problem Codes	Optical Problem (3001); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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 or Problem Description
It was reported to boston scientific corporation that a spyscope ds was used during a cholangioscopy procedure performed in the bile duct on (b)(6) 2021.According to the complainant, during the procedure, no image appears on the screen after connecting the spyscope ds and switching on the controller.The procedure was re-scheduled for next week due to scope unavailability.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1 (initial reporter phone): (b)(6).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 was analyzed, and a visual evaluation noted 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.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.The handle showed no damage to printed circuit board assembly (pcba) or camera wires.The reported event was confirmed.Evidence from x-ray showed a cloudy area at the rdl and camera wires at the distal tip, consistent with fluid ingress from procedure or humidity exposure during sterilization.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.Based on all available 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 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 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 or Problem Description
It was reported to boston scientific corporation that a spyscope ds was used during a cholangioscopy procedure performed in the bile duct on (b)(6) 2021.According to the complainant, during the procedure, no image appears on the screen after connecting the spyscope ds and switching on the controller.The procedure was re-scheduled for next week due to scope unavailability.There were no patient complications reported as a result of this event.

• Brand Name: SPYSCOPE DS
• Common Device Name: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11237365
• Report Number: 3005099803-2021-00255
• Device Sequence Number: 17104537
• Product Code: FBN
• UDI-Device Identifier: 08714729863236
• UDI-Public: 08714729863236
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/24/2021
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 0024829497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1