MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIVA TRACTIP; POWERED LASER SURGICAL INSTRUMENT

Model Number	M0068403960
Medical Device Problem Codes	Degraded (1153); Overheating of Device (1437)
Health Effect - Clinical Codes	Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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 or Problem Description
It was reported to boston scientific corporation on may 2, 2022 that a flexiva tractip laser fiber was used in a ureteroscopy with laser lithotripsy procedure for a stone treatment in the ureter performed on (b)(6) 2022.The laser console unit used was a p100 laser console.During the procedure, the laser fiber was not working well on the stone.The nurse went to change the laser fiber and burnt her thumb from the fiber connector.The nurse had two small blisters and was treated at home.The procedure was completed with another flexiva tractip laser fiber.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device code a1005 captures the reportable event of fiber connector overheats.Block h10: investigation result.The returned flexiva tractip laser fiber was analyzed, and a visual evaluation noted that the laser fiber was returned in one piece.The laser fiber body measured 314.7 cm from the distal tip to the proximal end of the sma connector.The exposed glass tip measured 4 mm and had normal degradation.A functional evaluation revealed that there was no light from the sma connector, indicating that there was a fracture within the connector.Additionally, the strain relief boot was not connected to the sma connector.The reported event of the flexiva tractip laser fiber overheats was confirmed.It is likely that the prolonged use of the device or condition of the stones caused the overheating.The device overheating led to the fracture with in the sma connector and separation of the strain relief boot from sma connector.Follow up also confirmed that the nurse who burned her finger treated the burn at home.Additionally, the ifu states, in the event of reduced or no laser energy output during application the fiber connector may be hot to touch.Review and analysis of all available information indicated that the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on may 2, 2022 that a flexiva tractip laser fiber was used in a ureteroscopy with laser lithotripsy procedure for a stone treatment in the ureter performed on april 29, 2022.The laser console unit used was a p100 laser console.During the procedure, the laser fiber was not working well on the stone.The nurse went to change the laser fiber and burnt her thumb from the fiber connector.The nurse had two small blisters and was treated at home.The procedure was completed with another flexiva tractip laser fiber.There were no patient complications reported as a result of this event.

• Brand Name: FLEXIVA TRACTIP
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): COHERENT INCORPORATED; 5100 patrick henry drive; santa clara CA 95054
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14487843
• Report Number: 3005099803-2022-02810
• Device Sequence Number: 4681183
• Product Code: GEX
• UDI-Device Identifier: 08714729808169
• UDI-Public: 08714729808169
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K110685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/05/2024
• Device Model Number: M0068403960
• Device Catalogue Number: 840-396
• Device Lot Number: 0000011449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown