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 04/28/2022

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 for treatment of biliary obstruction.During the procedure, the exalt model d scope lost visualization and an error screen appeared.The physician switched to another 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 for treatment of biliary obstruction.During the procedure, the exalt model d scope lost visualization and an error screen appeared.The physician switched to another 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 device 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; a live, clear image was displayed.The scope was articulated in all directions; the image was lost and the scope error screen appeared when the scope was articulated fully up & right simultaneously.To determine if issues with the light-emitting diode (led) signal contributed to image loss, the scope was unplugged and re-plugged into the controller and the led was turned off from the controller.The scope was then articulated up & right and image was lost again, indicating the issue was unrelated to led function.Electrical components in the distal tip were visualized under real-time x-ray to identify potential damage.At approximately 10mm proximal to the distal cap, a kinked cable and potential damage was observed under x-ray.The camera cable was removed from the scope and the distal end was stripped to access the wires.The twin-ax camera cable was kinked and potential damage to the external braid or low-voltage differential signaling (lvds) wires within was observed under x-ray imaging.Additionally, it was noted that adhesive had traveled along the twin-ax wire from the glue feature at the distal end of the camera cable.The twin-ax wire was stripped and the lvds wires inside were accessed; damage to the red lvds wire was apparent under magnification and x-ray inspection.The reported event was confirmed.Therefore, based on the investigation findings, the probable cause for the reported event was determined to be manufacturing deficiency, which indicates that the failure mode is attributable to the manufacturing process.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 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: 14468736
• MDR Text Key: 292354797
• Report Number: 3005099803-2022-02802
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2023
• Device Model Number: M00542421
• Device Catalogue Number: 42421
• Device Lot Number: 0027863220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2021
• 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
• Patient Age: 65 YR
• Patient Sex: Male