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

Model Number M00542421

Device Problems Break (1069); Optical Problem (3001); Positioning Problem (3009)

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

Event Date 06/17/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant indicated that the device is not available for return; 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) performed on (b)(6) 2022 for treatment of biliary obstruction.During the procedure, the physician was attempting to cannulate the papilla for about 20 minutes when visualization inside the patient was lost and the scope error screen appeared.It was also noted that the exalt model d single-use duodenoscope movements were not responding correctly.The physician then removed the exalt model d single-use duodenoscope from the patient and observed that the distal tip of the scope had partially detached from the insertion tube.This procedure was completed with a second exalt model d single-use duodenoscope.There were no patient complication reported as 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: 15042400
• MDR Text Key: 304615251
• Report Number: 3005099803-2022-03903
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729993605
• UDI-Public: 08714729993605
• Combination Product (y/n): N
• 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
• Report Date: 07/18/2022

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: 02/16/2024
• Device Model Number: M00542421
• Device Catalogue Number: 42421
• Device Lot Number: 0028883680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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 Sex: Female