MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT MODEL D SINGLE-USE DUODENOSCOPE; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00542421

Device Problem Optical Problem (3001)

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

Event Date 06/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon 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 an exalt model d single-use duodenoscope was used during an endoscopic retrograde cholangiopancreatography (ercp) performed in the bile duct on (b)(6) 2021.During the procedure, visualization was lost.It was reported that the loading screen appeared, followed by the boot screen.The physician turned the controller off and tried unplugging the exalt scope and plugging it back in; however, the problem was not resolved.The procedure was completed with a non-bsc, reusable duodenoscope.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that an exalt model d single-use duodenoscope was used during an endoscopic retrograde cholangiopancreatography (ercp) performed in the bile duct on (b)(6) 2021.During the procedure, visualization was lost.It was reported that the loading screen appeared, followed by the boot screen.The physician turned the controller off and tried unplugging the exalt scope and plugging it back in; however, the problem was not resolved.The procedure was completed with a non-bsc, reusable duodenoscope.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block h10: the returned exalt model d single-use duodenoscope was analyzed, and a visual evaluation noted that there was no evidence of any damage or defect on the shaft or tip of the device.No fogging or condensation was noted on or in the lens.An image assessment was performed by connecting the device to an exalt controller.Upon connection, a live image was displayed.No problems were observed with the image.Articulation of the scope was performed using the control knobs on the handle, and the image became disrupted when the tip was articulated in the "left" direction.The 5-dot reconnection screen displayed, and then the scope error screen.The unit was disconnected, the tip was straightened, and the device was reconnected to the controller; a live image was displayed until the scope was articulated in the "left" direction.The scope error screen could be avoided, and the camera image reconnected, if the scope was articulated back into a straight orientation while the 5-dot screen was still showing.X-ray inspection of the wiring in the distal tip was conducted.A region of kinked camera wires was observed.The tip of the device was removed and the distal end of the camera wires were exposed.Kinking of the overall camera bundle was observed proximal to the distal cap.The protective wrap was removed and epoxy was observed to have wicked from the camera pcba (printed circuit board assembly), proximally along the camera wires, and a kink in the shiny blue twin-ax camera cable was observed.The kinked twin-ax camera cable was isolated and stripped to expose the interior conductors.Kinks in the twin-ax conductors were observed.Additionally, exposed conductors were observed through a compromised jacket on the white cable.The reported event was confirmed.Product analysis confirmed that the device lost visualization when the scope was articulated, and dissection of the device found a compromised camera wire jacket in the white twin-ax cable, exposing the conductors within.An investigation to address this problem is in progress.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.

• Brand Name: EXALT MODEL D SINGLE-USE DUODENOSCOPE
• Type of Device: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12081610
• MDR Text Key: 260835399
• Report Number: 3005099803-2021-03128
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729993605
• UDI-Public: 08714729993605
• Combination Product (y/n): N
• PMA/PMN Number: K193202
• 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: 08/12/2021

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: 10/05/2022
• Device Model Number: M00542421
• Device Catalogue Number: 42421
• Device Lot Number: 0026114989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Initial Date Manufacturer Received: 06/06/2021
• Initial Date FDA Received: 06/28/2021
• Supplement Dates Manufacturer Received: 07/16/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1