MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DISCOVER DIGITAL CATHETER

Model Number M00546780

Device Problems Poor Quality Image (1408); Appropriate Term/Code Not Available (3191)

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

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

(pro code): ntn.(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 Description

It was reported to boston scientific corporation that a spy discover catheter was used during a laparoscopic cholecystectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the spy discover catheter image was blurred and would not auto focus despite an effort to clean and remove the catheter, and a replacement device was not available.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block d2b (pro code): ntn.Block h6 (device codes): problem code a27 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the returned spyglass discover digital catheter was analyzed, and a visual evaluation noted that no forceps marks were noted on the shaft of the catheter, and the lens had no damage or defect.Witness marks were observed on the contacts of the umbilicus connector, indicating it was connected to a controller.An image assessment for visualization was performed.The device was plugged into the controller.A live, clear image was displayed.No problems were identified with the image.No problems were observed with physical connectivity of the device.The umbilicus connector was visually inspected and no damage or defects were noted.No other problems with the device were noted.The device was fully articulated in all directions; no problems were identified with the image.The autofocus was tested by pointing the camera at texted on paper, and there was no problem observed.Switching between text and a flat surface rapidly did not identify any focus problems.X-ray imaging of the distal tip showed no problems with the redistribution layer (rdl), thru-silicon vias (tsvs), or camera wire.X-ray imaging of the handle showed no problems with the printed circuit board assembly (pcba) or camera wires.The handle was opened and the connection of the camera wires to the pcba was inspected.No damage or defect was noted on the bond between the solder pads and the camera wires.The glue feature was wiggled with tweezers to test the solder bond of the wires, and no change to the image was noted.Pressure was applied to the ground pad on the pcba using a screwdriver, and no flex was observed on the pcba.It appeared fully bonded to the breakout and no components on the board appeared damaged.The camera wire in the breakout region was visually inspected.No damage was noted to the camera wire or jacket.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.The reported event was not confirmed.Product analysis was unable to replicate or identify any problem that could have caused or contributed the reported event.A device history record (dhr) review confirms the device met all manufacturing specifications, and therefore there is unlikely a problem related to manufacturing.A review of the risk documentation confirms that the problem is not a new or unanticipated event, and therefore it is unlikely a problem with the design of the device.Based on all gathered information, the complaint investigation conclusion code selected for the visualization issue is no problem detected, which indicates that the device complaint or problem cannot be confirmed.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

It was reported to boston scientific corporation that a spy discover catheter was used during a laparoscopic cholecystectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the spy discover catheter image was blurred and would not auto focus despite an effort to clean and remove the catheter, and a replacement device was not available.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: SPYGLASS DISCOVER DIGITAL CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11113379
• MDR Text Key: 225107638
• Report Number: 3005099803-2020-06575
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729994183
• UDI-Public: 08714729994183
• Combination Product (y/n): N
• PMA/PMN Number: K200483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

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: 11/16/2022
• Device Model Number: M00546780
• Device Catalogue Number: 4678
• Device Lot Number: 0026367547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 113