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

Model Number M00542421

Device Problems Device Sensing Problem (2917); Optical Problem (3001)

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

Event Date 09/22/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6 (device codes): 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 a biliary obstruction, on (b)(6) 2023.During the procedure, the image light source went out after advancing the scope into the duodenum.As a result, the visualization was lost, and the scope was removed from the patient.No patient complications were reported as a result of this event.

Manufacturer Narrative

Imdrf device code a06 captures the reportable event of loss of visualization inside the patient.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 elevator was tested for actuation using the thumb lever on the handle; no issues were observed.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.Manipulation of the umbilicus connector did not prompt any failure with the image or lighting.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 visual defects 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.

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 a biliary obstruction, on (b)(6) 2023.During the procedure, the image light source went out after advancing the scope into the duodenum.As a result, the visualization was lost.No patient complications were reported 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: 17965124
• MDR Text Key: 326036512
• Report Number: 3005099803-2023-05564
• 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: 10/19/2023
• 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: 0032343275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2023
• 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
• Patient Age: 81 YR
• Patient Sex: Male