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

Model Number M0067913500

Device Problem Positioning Problem (3009)

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

Event Date 07/15/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a lithovue flexscope was used during flexible endoscopy ureterolithotomy procedure performed on (b)(6) 2022.During procedure, physician noticed that the scope would only deflect downwards.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: impact code f1001 is being used to capture the reportable issue of aborted procedure.Block h10: the returned lithovue flexscope was analyzed, there was no visual damage to the distal tip, handle and shaft.The working channel was test with a syringe of air and found to not leak.X-ray images identified damage to the pull wire from the tail coupler at the tip.The returned device had no articulation in both directions confirming the reported complaint.The returned device was tested for image on a lithovue touch pc.It was able to display a live, clear image.The reported event was confirmed.A risk review confirmed that the event is accounted for in the risk documentation the broken pull wire is likely due to procedural conditions in conjunction with significant force used on the articulation lever during the procedure, up to the limit of the device design.The distal tip had signs of usage and procedural data indicated the scope was used for approximately 45 minutes.Based on the information gathered, a conclusion code of adverse event related to procedure is assigned, indicating the adverse event occurred during the procedure and the device had no influence on event.A similar complaint review was not performed.There is no indication of a potential process or design related issue to the batch number reported.

Event Description

It was reported to boston scientific corporation that a lithovue flexscope was used during flexible endoscopy ureterolithotomy procedure performed on (b)(6) 2022.During procedure, physician noticed that the scope would only deflect downwards.The procedure was cancelled due to this event.There were no patient complications reported as a result of this 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: 15228224
• MDR Text Key: 302018858
• Report Number: 3005099803-2022-04608
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 08714729874805
• UDI-Public: 08714729874805
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K153049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

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: 11/11/2023
• Device Model Number: M0067913500
• Device Catalogue Number: 791-350
• Device Lot Number: 0028371288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• 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