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

Model Number M00542421

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)

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

Event Date 01/11/2022

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) 2022 to treat stones in the bile duct.During the procedure, the exalt model d scope lost visualization in the patients duodenum.The exalt controller was restarted and visualization was restored for ten seconds before being lost again.The physician switched to a second exalt model d scope and completed the procedure.There were no patient complications 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) procedure performed on (b)(6) 2022 to treat stones in the bile duct.During the procedure, the exalt model d scope lost visualization in the patients duodenum.The exalt controller was restarted and visualization was restored for ten seconds before being lost again.The physician switched to a second exalt model d scope and completed 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.No issues with the device handle were noted.No damage to the umbilicus cable, connector, or its ports were observed.An image assessment was performed by connecting the device to an exalt controller.Upon connection, a live, clear image was displayed.The scope was articulated in all directions; when the scope was articulated in the up and left directions simultaneously, the image was lost and the scope error screen displayed.The image and articulation were tested again by unplugging and plugging in the device, then turning off the light emitting diode (led) from the controller.No image issues were observed.During subsequent testing of the device, the image issue could not be replicated again.Electrical testing of the device with a digital multimeter was performed and found continuous connections throughout the scope, and articulation of the tip did not present any fault conditions.Electrical components in the distal tip and umbilicus connector were visualized under real-time x-ray to identify potential damage.No issues were observed in the umbilicus connector.Potential damage to conductors in the distal tip was observed near the camera printed circuit board assembly (pcba).The tip of the device was removed and the camera cable bundle was removed from the scope.X-ray analysis was performed again, as fewer obstructions were present, allowing a clearer view.With a clearer view, it was noted that there was damage to the outer shield of the twin-ax camera cable and the outer cathode braid of the led cable.The distal end of the wires were further exposed by removing the protective wrap and isolating both the twinaxial and led cables.The twinaxial cable was stripped, exposing the interior conductors (low voltage differential signaling wires); an x-ray of the low voltage differential signaling wires on their own showed damage to each wire, corresponding to the location of the damage observed to the outer shield.Furthermore, x-ray inspection of the isolated led cable demonstrated damage to the led cathode (outer braid), and potential damage to the inner conductor.Product analysis confirmed that the scope image was lost when the tip was articulated.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, specifically of the led cable in the distal end of the scope.An investigation to address this issue 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 labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / 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
• 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: 13446404
• MDR Text Key: 289187018
• Report Number: 3005099803-2022-00479
• 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: 03/11/2022

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: 06/09/2023
• Device Model Number: M00542421
• Device Catalogue Number: 42421
• Device Lot Number: 0027462169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 02/03/2022
• Supplement Dates Manufacturer Received: 02/17/2022
• Supplement Dates FDA Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2021
• 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