MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER LITHOVUE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M0067913500

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2016

Event Type  malfunction  

Manufacturer Narrative

The device has been received for analysis.Upon completion of the failure analysis of the complaint device, 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 single-use digital flexible ureteroscope was used during a ureteroscopy procedure performed on (b)(6) 2016 according to the complainant, during the procedure when attempting to advance the scope to the ureter, the anatomy was tight, and the scope was unable to advance through the anatomy.The device was removed and upon removal the device was noted to be kinked and could not be straightened.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

A visual analysis found that the scope's working length demonstrated signs of use, however, no damages were noted on the device and its components.A functional evaluation found no issues with articulation a syringe was used to inject air into the working channel luer with the open luer and distal end blocked; no leak was observed.The working channel would hold a vacuum.The condition of the returned incident device showed no evidence of the alleged issue or any defect which could have contributed to the event.The complaint was not confirmed.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a lithovue single-use digital flexible ureteroscope was used during a ureteroscopy procedure performed on (b)(6) 2016.According to the complainant, during the procedure when attempting to advance the scope to the ureter, the anatomy was tight, and the scope was unable to advance through the anatomy.The device was removed and upon removal the device was noted to be kinked and could not be straightened.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: LITHOVUE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6219952
• MDR Text Key: 63799517
• Report Number: 3005099803-2016-04116
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 08714729874805
• UDI-Public: (01)08714729874805(17)20180630(10)19370775
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/09/2016

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: 06/30/2018
• Device Model Number: M0067913500
• Device Catalogue Number: 791-350
• Device Lot Number: 19370775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 01/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• 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