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

Model Number M00542421

Device Problem Optical Problem (3001)

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

Event Date 09/21/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device 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 single use duodenoscope was used during an endoscopic retrograde cholangiopancreatography (ercp) to treat choledocholithiasis, on (b)(6) 2023.During the procedure, the physician was using spy scope and exalt model d scope with electrohydraulic lithotripsy (ehl), to remove a large stone.The spy scope was removed from the exalt model d scope to go in and clean the duct out with an extractor pro retrieval balloon.Once the spy scope was removed, the exalt model d scope image was lost.The exalt model d scope loading screen was displayed.Therefore, the physician switched to a reusable scope to complete the procedure.No patient complications were reported as a result of this event.

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) to treat choledocholithiasis, on (b)(6) 2023.During the procedure, the physician was using spy scope and exalt model d scope with electrohydraulic lithotripsy (ehl), to remove a large stone.The spy scope was removed from the exalt model d scope to go in and clean the duct out with an extractor pro retrieval balloon.Once the spy scope was removed, the exalt model d scope image was lost.The exalt model d scope loading screen was displayed.Therefore, the physician switched to a reusable scope to complete the procedure.No patient complications were reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a06 captures the reportable event of loss of visualization inside the patient.Block h10: the returned exalt model d single use duodenoscope was analyzed, passed all tests performed, and exhibited normal device characteristics.A visual inspection of the returned device revealed no evidence of damage on the shaft or tip of the device.No fogging or condensation was noted on or in the lens.Witness marks were observed on the pads of the umbilicus connector, indicating it was connected to a controller.The device imaging was tested by plugging the umbilicus connector into a controller, and a live image was displayed, and the light-emitting diode (led) turned on.No issues against the image or lightning were observed.Articulation of the tip was performed using the control knobs on the handle, and no changes to the image quality were observed.The tip was manually manipulated, and no issues were observed with the image.Manipulation of the umbilicus connector did not prompt any failure with the image or lighting.A non-complaint spyscope ds ii device was plugged into its controller to turn it on, and the scope was passed into the returned exalt model d scope biopsy port and through the working channel until it exited the distal end.The spyscope ds ii was removed from the working channel; no exalt image issues were observed during this testing.The handle was opened to visually inspect the repeater button printed circuit board (pcba) at the top of the handle; no visual defects were identified.The umbilicus connector was opened to visually inspect the electronic components inside; no issues were identified.With all the available information, boston scientific corporation could not confirm the reported event.As product analysis was unable to replicate the reported issue or identify any problem that could have caused or contributed to the reported event.The conclusion code selected for this event is no problem detected.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 directions for use (dfu) / 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: 17951349
• MDR Text Key: 325915857
• Report Number: 3005099803-2023-05483
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729993605
• UDI-Public: 08714729993605
• 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: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• 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
• Device Lot Number: 0032033589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2023
• 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