MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LITHOVUE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number 791-350

Device Problems Contamination (1120); Unsealed Device Packaging (1444)

Patient Problem Insufficient Information (4580)

Event Date 03/09/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant indicated that the device has been 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 a lithovue flexscope was opened for use on (b)(6) 2021 for a ureteroscopy procedure.It was reported that during preparation , when the box was opened the plastic pouch that the lithovue scope is contained in was not fully sealed.The procedure was completed with a second lithovue scope.There were no patient complications reported as a result of the event.

• Brand Name: LITHOVUE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11854564
• MDR Text Key: 251684979
• Report Number: 3005099803-2021-02358
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 08714729874805
• UDI-Public: 08714729874805
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2023
• Device Model Number: 791-350
• Device Catalogue Number: 791-350
• Device Lot Number: 0026826679
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2021
• 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