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

Model Number M0067913500

Device Problems Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/12/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a lithovue flexscope was used during a right laser nephrolithotripsy procedure performed on (b)(6) 2022.During procedure, 365-micron lumenis fiber, 200-micron laser fiber, sensor guidewire and zero tip basket presented resistance upon inserting through the working channel of the scope.Reportedly, the distal tip of the scope showed obstruction issues.The physician decided to stop the procedure and not to keep the patient under anesthesia for a long time.The procedure was canceled due to this event.There were no patient complications as a result of this event.

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that a lithovue flexscope was used during a right laser nephrolithotripsy procedure performed on (b)(6) 2022.During procedure, 365-micron lumenis fiber, 200-micron laser fiber, sensor guidewire and zero tip basket presented resistance upon inserting through the working channel of the scope.Reportedly, the distal tip of the scope showed obstruction issues.The physician decided to stop the procedure and not to keep the patient under anesthesia for a long time.The procedure was canceled due to this event.There were no patient complications 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 (investigation results): the returned lithovue flexscope was analyzed, and a visual inspection of the device observed damage to the shaft at the articulation section.The working channel had signs of laser damage at the distal tip.X-ray images confirmed both damages and identified no other damages or defects to the device.Functional testing detected no issues, the device was able to fully articulate in both directions.The working channel was tested with a syringe of air and confirmed that the working channel did leak.A 0.038 guidewire was able to pass through the working channel without difficulty or resistance.The reported complaint was not confirmed.This investigation is assigned a probable cause of unintended use error caused or contributed to event.This conclusion was selected because the interaction between the user and device, or sample, caused or contributed to the error.This includes unintended inappropriate use of the device and incorrect sample preparation due to the inadvertent damage caused by laser fire.A review of the manufacturing documentation for this device confirmed that the reported complaint difficult/unable to advance was defined in the risk documentation.

• 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: 15700484
• MDR Text Key: 303236101
• Report Number: 3005099803-2022-06415
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 08714729874805
• UDI-Public: 08714729874805
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 02/07/2023

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: 11/18/2023
• Device Model Number: M0067913500
• Device Catalogue Number: 791-350
• Device Lot Number: 0028410600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 01/23/2023
• Supplement Dates FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2021
• 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
• Patient Sex: Male