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); Mechanical Jam (2983)

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

Event Date 10/17/2023

Event Type  malfunction  

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) performed on (b)(6) 2023 to treat a cholangiocarcinoma.During the procedure, the imaging became blurry and did not resolve after irrigating.Additionally, the elevator would not respond to the lock function.The procedure was completed using a reusable scope and there were no patient complications as a result of this event.

Manufacturer Narrative

Block h6: imdrf code a090208 is being used to capture the reportable event of poor-quality image.Block h9: 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.

• 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: 18100518
• MDR Text Key: 329014199
• Report Number: 3005099803-2023-06123
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• 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: 0031607291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 97090504-FA
• Patient Sequence Number: 1