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

Model Number M00542421

Device Problems Poor Quality Image (1408); Optical Problem (3001)

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

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.

Event Description

It was reported to boston scientific corporation that an exalt model d scope was used on an endoscopic retrograde cholangiopancreatography (ercp) used to treat choledocholithiasis performed on (b)(6) 2023.During cannulation, the physician reported that there was a quick flash on the monitor.After this flash, the screen was pixelated.The scope was then unplugged from the exalt model d controller.After waiting a few seconds, the scope was plugged back in, at that point, the controller shut down.The cables were checked and there were no issues.After turning the controller off and on, the image appeared, and the scope was plugged in again.The controller shut down again.The physician then withdrew the exalt scope from the patient using fluoroscopic guidance.The procedure was successfully completed using a reusable scope.There were no patient complications as a result of this event.

Manufacturer Narrative

Blocks d4 and h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block h10: the returned device was analyzed, and a visual evaluation noted that the device returned without any visible failure.A functional evaluation noted that an image test was conducted by connecting the umbilicus to a monitor.The monitor showed the image as expected.No other problems with the device were noted.The reported event was not confirmed.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) and product label.Based on the findings during the product investigation, the reported event could not be confirmed.There is no reported problem on the exalt model d controller that was used with the scope during the procedure but it is possible that the controller interfered with the correct performance of this device.

Event Description

It was reported to boston scientific corporation that an exalt model d scope was used on an endoscopic retrograde cholangiopancreatography (ercp) used to treat choledocholithiasis performed on (b)(6), 2023.During cannulation, the physician reported that there was a quick flash on the monitor.After this flash, the screen was pixelated.The scope was then unplugged from the exalt model d controller.After waiting a few seconds, the scope was plugged back in, at that point, the controller shut down.The cables were checked and there were no issues.After turning the controller off and on, the image appeared, and the scope was plugged in again.The controller shut down again.The physician then withdrew the exalt scope from the patient using fluoroscopic guidance.The procedure was successfully completed using a reusable scope.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: 18425501
• MDR Text Key: 331932361
• Report Number: 3005099803-2023-06944
• Device Sequence Number: 1
• Product Code: FDT
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00542421
• Device Catalogue Number: 42421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Prefer Not To Disclose