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 10/07/2022

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 (b)(6) 2022 for coledocolitiasis.During the procedure with exalt model d scope, visualization was lost.The exalt scope was unplugged and plugged back but the image was unable to be recovered.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 october 07, 2022 for coledocolitiasis.During the procedure with exalt model d scope, visualization was lost.The exalt scope was unplugged and plugged back but the image was unable to be recovered.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 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 displayed.The scope was tested for articulation.When the scope was articulated to the right, the image was lost; the loading exalt screen was displayed and then, the scope error screen.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.Therefore, the reported image loss was confirmed as it was replicated by articulating the scope with a live image on the screen.The resistance was measured using a digital multimeter on the repeater button pcba (printed circuit board assembly).With the device unplugged and the distal end in a straight orientation, the resistance was 61 ohms, as expected.With the device unplugged and the distal end articulated to the right (image failure position) the resistance was 100 ohms, indicating a potential open on one or both low voltage differential signaling (lvds) wires in the twin-ax camera wire.During returned product testing a slight kink in the twin-ax camera cable and damage to the white lvds wire within were observed at approximately 10mm proximal to the distal end.It is likely that the damaged lvds wire maintained a connection to carry a signal with the scope in a straight orientation, however, when the scope was articulated to the right, the damaged region created an electrical open on the wire, resulting in a loss of image.The slight kink in the twin-ax cable suggests handling damage during supplier manufacturing of the imager and cable assembly.Based on all gathered information the probable cause for the reported event was determined to be manufacturing deficiency, which indicates that the failure mode is attributable to the supplier manufacturing process.An investigation to address this problem has been completed.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: 15700958
• MDR Text Key: 303235926
• Report Number: 3005099803-2022-06380
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729995753
• UDI-Public: 08714729995753
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 06/13/2023

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: 01/11/2024
• Device Model Number: M0054242CE1
• Device Catalogue Number: 4242CE
• Device Lot Number: 0028661108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 05/24/2023
• Supplement Dates FDA Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2022
• 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