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 11/13/2023

Event Type  malfunction  

Event Description

It was reported that an exalt model d single-use duodenoscope was used during an endoscopic retrograde cholangiopancreatography (ercp) for management of stones on (b)(6) 2023.During the procedure, visualization was lost and the scope error screen appeared on the monitor.The exalt model d controller was restarted multiple times.The procedure was able to be completed with the original scope using x-ray visualization.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.

Manufacturer Narrative

Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block h10: with all the available information boston scientific concludes that the reported event was unable to be confirmed, as loss of visualization was not replicated during analysis.The returned device was visually inspected; no external defects were identified with the scope handle, insertion tube, distal end, or umbilicus components.The elevator was tested using the thumb lever on the handle; no elevator actuation issues were observed.The scope was plugged into an exalt model d controller; a live, clear image displayed.The scope was articulated using the knobs on the handle and no articulation issues were observed.T the knobs and distal end articulated in all directions and combinations of directions.No issues with the live image were observed during this testing.The umbilicus cable and plug were manipulated to test the connection between the scope and controller; no image issues were observed.The photo provided by the account was reviewed; the scope error screen was displayed on the customer monitor.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.Based on all gathered information, boston scientific concludes that the reported event not confirmed.The device returned without any visible failure and after a functional and electrical inspections, no failure was observed on the device.

Event Description

It was reported that an exalt model d single-use duodenoscope was used during an endoscopic retrograde cholangiopancreatography (ercp) for management of stones on (b)(6) 2023.During the procedure, visualization was lost and the scope error screen appeared on the monitor.The exalt model d controller was restarted multiple times.The procedure was able to be completed with the original scope using x-ray visualization.There were no patient complications 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: 18311830
• MDR Text Key: 330354285
• Report Number: 3005099803-2023-06663
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 02/09/2024

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 Model Number: M0054242CE1
• Device Catalogue Number: 4242CE
• Device Lot Number: 0030893081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2023
• 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