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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact age of the patient is unknown.However, it was reported the patient was over 18 years old.(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 or Problem Description
It was reported to boston scientific corporation that a spyscope ds catheter was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the common bile duct on (b)(6) 2021.During the procedure, the image of the spyscope ds was lost a few minutes into the procedure during fluroscopy shots.The physician decided not to fire the electrohydraulic lithotripsy (ehl) probe and turned off the controller.After a few minutes, the controller was turned back on and a gray image with three dots appeared on the screen.The procedure was rescheduled to perform the lithotripsy in a future session.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a spyscope ds catheter was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the common bile duct on (b)(6) 2021.During the procedure, the image of the spyscope ds was lost a few minutes into the procedure during fluroscopy shots.The physician decided not to fire the electrohydraulic lithotripsy (ehl) probe and turned off the controller.After a few minutes, the controller was turned back on and a gray image with three dots appeared on the screen.The procedure was rescheduled to perform the lithotripsy in a future session.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block a2: the exact age of the patient is unknown.However, it was reported the patient was over 18 years old.Block h6 (device codes): impact code f05 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 noted that 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.A media inspection of a photo of the event from the customer confirmed that there was a lost image.The device was connected to a console and no image resulted.X-ray imaging of the distal tip showed a poor connection between the camera wires and the camera at the redistribution layer (rdl).X-ray imaging of the handle showed no damage to printed circuit board assembly (pcba) or camera wires.No other problems with the device were noted.The reported event was confirmed.Evidence from x-ray showed a poor connection between the camera wires and the camera at the rdl in the distal tip.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.Based on all gathered information, the probable cause selected for the visualization problem due to poor camera wire connection in the distal tip 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 instructions for use (ifu) / product label.

• 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
• 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: 12924397
• Report Number: 3005099803-2021-06277
• Device Sequence Number: 4905906
• Product Code: FBN
• UDI-Device Identifier: 08714729863236
• UDI-Public: 08714729863236
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2019
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 0020624267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 02/06/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female