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 10/22/2021

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 on (b)(6) 2021 to treat cholangiocarcinoma.During the procedure, as the physician was advancing the scope to the papilla, the exalt scope lost visualization and the image went black.The exalt scope was unplugged and plugged back into the controller but the image could not be restored.At that point, the physician decided to switch to a reusable duodenoscope to complete the procedure.There were no patient complications 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 visually inspected.No evidence of any damage or defect was observed on the shaft or tip of the device.No fogging or condensation was noted on or in the lens.Witness marks were observed on the pads of the umbilicus connector.An image assessment was performed by connecting the device to an exalt controller.Upon connection, a live image was displayed.The scope was articulated in all directions.When the scope was articulated in the up direction, the light emitting diode (led) at the tip of the device flickered.The articulation knob was rotated abruptly in the up direction and the led turned off, followed by the scope error screen on the monitor.This was repeated by unplugging and re-plugging in the scope umbilicus connector at the controller.Again, the led and image were present, but when the articulation knob was rotated abruptly in the up direction, led and image were lost.The scope was unplugged and plugged back in once again, but the led was turned off at the controller before the scope error screen could display.The image remained on and no issues were observed when the scope was articulated in all directions and combinations of directions.The image issue was traced to a problem with the led electrical assembly.The umbilicus connector, handle, and distal tip were visualized under real-time x-ray imaging.No issues were observed with the umbilicus connector or the printed circuit board assembly (pcba) in the handle.A potential open was observed in wiring at the distal tip of the scope.The handle and umbilicus connector of the device were opened and it was confirmed that no damage was present on the pcba or interposers.It was confirmed using a digital multimeter that the conductors in the umbilicus connector were continuous by probing the umbilicus 12-pin interposer and pcba interposers each signal, isolating the issue to be distal to the umbilicus connections in the handle.The camera cable was cut in the handle and the distal cap was disconnected from the shaft.The tubing and elevator actuation wire in the distal tip were severed and the camera wire was removed from the scope.The camera wire was x-rayed again, and further indicated a potential open in the exterior braided cathode of the led cable.The distal cap was broken open to better access the termination of the wires at the imager board in the distal cap.The protective coverings were removed from the wire bundle, and the damaged led cathode braid was visualized under magnification.Product analysis confirmed that the device would lose visualization when the scope was articulated in the up position.Damage was found to the led cathode braid at the distal tip of the scope, resulting in a lack of led.This automatically reverts the display to the scope error screen when plugged into a controller with the led function on.Therefore, the reported event was confirmed.Based on all available information, the conclusion code selected for this event is cause traced to component failure, which indicates that the issues are traced to expected or random failure of a device component.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 found one additional complaint related to loss of visualization against this batch was identified since manufacturing in january 2021, however, the complaint was not confirmed upon returned product analysis.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / 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 on (b)(6) 2021 to treat cholangiocarcinoma.During the procedure, as the physician was advancing the scope to the papilla, the exalt scope lost visualization and the image went black.The exalt scope was unplugged and plugged back into the controller but the image could not be restored.At that point, the physician decided to switch to a reusable duodenoscope to complete the procedure.There were no patient complications 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12806407
• MDR Text Key: 281923561
• Report Number: 3005099803-2021-05874
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729993605
• UDI-Public: 08714729993605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2023
• Device Model Number: M00542421
• Device Catalogue Number: 42421
• Device Lot Number: 0026652726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 01/19/2022
• Supplement Dates FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1