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

Model Number M00542420

Device Problems Fluid/Blood Leak (1250); Appropriate Term/Code Not Available (3191)

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

Event Date 02/19/2021

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 and hydratome were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the ampulla on (b)(6) 2021.The patient had a medical history of jaundice and was reported to be morbidly obese.During the procedure, the ampulla was difficult to access due to an external compression problem in the patient.It was reported that there was no difficulty advancing the scope to the target site.It was unknown what was causing the compression problem; however, it was noted that the patient's weight could have been a contributing factor to difficulty accessing the ampulla.Additionally, there was pooling of fluid over the lens of the exalt scope which made it difficult for the physician to access the ampulla.The physician also experienced difficulty cannulating with the hydratome device.It was reported that the working length was torn, and the wire anchor dislodged from the catheter.No part of the tome fell inside the patient.Additionally, it was reported that the orientation of the catheter was at 10-11 o'clock after exiting the scope.The procedure was not completed due to this event.There were no patient complications 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: 11509258
• MDR Text Key: 240671779
• Report Number: 3005099803-2021-01045
• 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: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2022
• Device Model Number: M00542420
• Device Catalogue Number: 42420
• Device Lot Number: 0026042272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2020
• 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