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

Model Number	M0054242CE1
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Event or Problem 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 on an unknown date.During the procedure, the physician reported that the scope's elevator produced a reflection that made the image quality very poor.The procedure was successfully completed using the original device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date, (b)(6) 2023, was chosen as a best estimate based on the date that the manufacturer became aware of the event, 10/05/2023.Block h6: imdrf code a090208 is capturing the reportable event of poor-quality image.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date, 10/01/2023, was chosen as a best estimate based on the date that the manufacturer became aware of the event, 10/05/2023.Block h6: imdrf code a090208 is capturing the reportable event of poor-quality image.Block h9 (correction/removal reporting #) on october 3, 2023, boston scientific issued a product removal notice (97090504-fa) to recall certain batches of the exalt model d single-use duodenoscope following an increase in reports of poor image quality due to fluid ingress in the lens.To address this known, uncommon malfunction, boston scientific has implemented corrective changes for replacement exalt model d scopes.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.The tip of the device was visually analyzed, and no issues were observed with the lens, elevator or working channel and irrigation lumen exits.No fluid or fogging was observed inside the lens assembly.The device image was tested by plugging the umbilicus connector into a controller and a live, clear image was displayed.No functional issues were identified involving the scope elevator, knobs or thumb lever on the handle.An orca a/w valve button was installed into the a/w valve port on the exalt handle.Irrigation and insufflation were functionally tested with a live image on the monitor by attaching a hydra water bottle cap to a filled water bottle and the fluidics port on the exalt umbilicus connector.No insufflation, irrigation or image issues were observed.A flow of water over the camera was seen in the live image.After fluidics testing, the image remained clear and the lens was inspected after fluidics testing; no fogging or fluid ingress into the lens assembly was observed.A risk review confirmed that the failure is accounted for in the risk documentation, with mitigations controlled by design and the manufacturing process, including image testing to verify image presence and quality.The reported complaint was not confirmed.However, on october 3, 2023, boston scientific issued a product removal notice (97090504-fa) for certain batches of the exalt model d single-use duodenoscope following an increase in reports of poor image quality due to fluid ingress in the lens.Although product analysis did not confirm a fluid ingress event, the device batch number was determined to be within scope of the product removal notice.With all the available information, boston scientific concludes the probable cause of the reported event was determined to be cause traced to device design, which indicates that the problems were traced to the imager design change.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem 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 on an unknown date.During the procedure, the physician reported that the scope's elevator produced a reflection that made the image quality very poor.The procedure was successfully completed using the original device.There were no patient complications reported as a result of this event.

• Brand Name: EXALT MODEL D SINGLE-USE DUODENOSCOPE
• Common Device Name: 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: 18057441
• Report Number: 3005099803-2023-05932
• Device Sequence Number: 12474893
• Product Code: FDT
• UDI-Device Identifier: 08714729995753
• UDI-Public: 08714729995753
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K193202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2025
• Device Model Number: M0054242CE1
• Device Catalogue Number: 4242CE
• Device Lot Number: 0031331654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 97090504-FA
• Patient Sequence Number: 1
• Patient Sex: Unknown