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 05/13/2021

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) procedure performed in the duodenum on (b)(6) 2021.During the procedure, the image intermittently changed between a live image and a blue screen.Eventually, the screen remained blue and then went to the ercp scope error screen.The physician unplugged the exalt scope and rebooted the controller.The physician plugged the scope back into the controller and the image was restored.Shortly thereafter, the image was lost again.The procedure was completed with a non-bsc 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 led and image would become disrupted when the tip was articulated in the "up" direction.The led would turn off and, after several seconds, the monitor would display 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 almost completely in the "up" direction.When the led was turned off on the controller before the error screen could display, the image would stay on.X-ray inspection of the wiring in the distal tip was conducted, both with the tip in a straight orientation, and with the tip articulated such that the error screen displayed.No problems were observed with the wires when the tip was in a straight orientation.With the tip articulated, potential damage to the led wire braid was observed, located within the distal cap, inaccessible to dissection and visual inspection.The device was disassembled and the wires external to the distal cap were visually inspected.No additional damage was observed.Product analysis confirmed that the device lost visualization when the scope was articulated, and x-ray imaging found that damage to the distal led wire braid resulted in an open when the scope was articulated.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.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 an exalt model d single-use duodenoscope was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the duodenum on (b)(6) 2021.During the procedure, the image intermittently changed between a live image and a blue screen.Eventually, the screen remained blue and then went to the ercp scope error screen.The physician unplugged the exalt scope and rebooted the controller.The physician plugged the scope back into the controller and the image was restored.Shortly thereafter, the image was lost again.The procedure was completed with a non-bsc duodenoscope.There were no patient complications reported as a result of this event.

• 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: 11953425
• MDR Text Key: 254885165
• Report Number: 3005099803-2021-02515
• 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: 07/16/2021

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: 02/04/2022
• Device Model Number: M00542421
• Device Catalogue Number: 42421
• Device Lot Number: 0025687787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1