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

Model Number M00542420

Device Problems Leak/Splash (1354); Optical Problem (3001)

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

Event Date 05/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

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) and spyglass with electrohydraulic lithotripsy (ehl) procedure performed in the common bile duct on (b)(6) 2021.Two hours into the procedure, there was a leak at the umbilicus of the exalt scope.The screen turned blue as a result and the image was lost.The procedure was completed with another exalt 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: 11938436
• MDR Text Key: 254296520
• Report Number: 3005099803-2021-02387
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729983514
• UDI-Public: 08714729983514
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2022
• Device Model Number: M00542420
• Device Catalogue Number: 42420
• Device Lot Number: 0026249442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2021
• Initial Date FDA Received: 06/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2020
• 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