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

Model Number M00542420

Device Problem Optical Problem (3001)

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

Event Date 08/24/2022

Event Type  malfunction  

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.During the procedure the scope was introduced and while the physician attempted to reach the ampulla, the visualization was lost, the image could not be regained.The scope was removed from the patient and the procedure was completed with another exalt model d scope.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and 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.

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; no image displayed, only the 5-dot initialization screen and the monitor reverted to the exalt splash screen.The scope was articulated in all directions during the initialization step, but the image could not be restored.The handle was opened to inspect internal components.No damage or defects to the printed circuit board assembly (pcba) or camera wires in the handle were observed.Using a digital multimeter in continuity mode, connections between the umbilicus and the handle were tested for resistance and continuity.All tests passed, including light-emitting diode (led) continuity through the device, resistance between ground and the clock (scl ) and serial data (sda) lines were approximately 600ohms, no short was found between power and ground, and no discontinuity was detected between the pads of the umbilicus connector and the j1 and j6 interposer connections on the handle pcba.The camera wire at the distal tip was visualized under real-time x-ray and potential damage was found in the form of a kink, when viewed through the intact catheter.The camera cable was removed from the scope and it was noted that the cable was kinked at approximately 10mm proximal to the distal tip.The wire was x-rayed again, and camera wire damage was noted in the region of the kink.The distal end of the camera cable was stripped to access the wires.The twin-ax camera cable was noted to be kinked, and potential damage to the external braid and/or low-voltage differential signaling (lvds) wires within was observed under x-ray imaging.Additionally, it was noted that adhesive had wicked (traveled) along the twin-ax cable 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 white lvds wire was observed.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.

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.During the procedure the scope was introduced and while the physician attempted to reach the ampulla, the visualization was lost, the image could not be regained.The scope was removed from the patient and the procedure was completed with another exalt model d scope.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
• 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: 15442231
• MDR Text Key: 301016310
• Report Number: 3005099803-2022-05252
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729983514
• UDI-Public: 08714729983514
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

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: 06/04/2023
• Device Model Number: M00542420
• Device Catalogue Number: 42420
• Device Lot Number: 0027438910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/24/2022
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2021
• 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