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

Model Number M0054242CE1

Device Problem Optical Problem (3001)

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

Event Date 11/03/2022

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 on (b)(6) 2022.During the procedure when the exalt model d scope was in the esophagus the visualization was lost.The exalt scope was unplugged and plugged back; however, the image was unable to be recovered.The scope was then removed from the patient with no visualization.Another exalt model d scope was used to complete the procedure.There were no patient complications as a result of this event.

Manufacturer Narrative

(b)(4).

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 on (b)(6) 2022.During the procedure when the exalt model d scope was in the esophagus the visualization was lost.The exalt scope was unplugged and plugged back; however, the image was unable to be recovered.The scope was then removed from the patient with no visualization.Another exalt model d scope was used to complete the procedure.There were no patient complications as a result of this event.

Manufacturer Narrative

Block h6: device code a06 captures the reportable event of loss of visualization inside the patient.Block h10 investigation summary: based on the available information, boston scientific corporation concludes that 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.Device history record: a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Device technical analysis: 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 displayed.The scope was tested for articulation.When the scope was articulated right or up, the image was lost; the 5-dot screen displayed, and then the exalt splash screen.The reported event was confirmed.The scope was unplugged and plugged back in, the light emitting diode (led) was turned off from the controller, and articulation testing was repeated.The image was lost again, indicating a likely issue with the distal camera wires, unrelated to the led wires.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 led continuity through the device, resistance between ground and the clock (scl) and data (sda) lines were approximately 600ohms, no short was found between power and ground.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 a kink in the twin-ax camera wire was observed.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 lvds wires within was observed under x-ray imaging.The twin-ax wire was stripped and the low voltage differential signaling (lvds) wires inside were accessed; damage to the red lvds wire jacket was observed.Labeling review: a product labeling review identified that the device was used per the directions for use (dfu) / product label.There is no evidence that the device was misused, or that there was any issue with translation, wording, or graphics.Investigation conclusion: 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.

• 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: 15926849
• MDR Text Key: 308073398
• Report Number: 3005099803-2022-07242
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729995753
• UDI-Public: 08714729995753
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 01/12/2023

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: 02/07/2024
• Device Model Number: M0054242CE1
• Device Catalogue Number: 4242CE
• Device Lot Number: 0028822993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 12/06/2022
• Supplement Dates Manufacturer Received: 12/22/2022
• Supplement Dates FDA Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2022
• 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