MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIVA (TM) TRACTIP HIGH POWER SINGLE-USE LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	M0068403961
Medical Device Problem Codes	Break (1069); Overheating of Device (1437)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device problem code: (b(4) medical device problem code: (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 march 16, 2022 that a flexiva tractip high power single use laser fiber was used in a laser lithotripsy & transurethral resection of the prostate (turp) procedure to treat stones in the kidney performed on (b)(6) 2022.The laser unit used was a holmium laser console.During the procedure, the laser fiber split apart and caused the fiber connector to overheat.No fiber fragments fell inside the patient and no reported burn injury to the user or to the patient.The procedure was completed with another flexiva tractip high power single use laser fiber.There were no patient complications reported as a result of this event.

• Brand Name: FLEXIVA (TM) TRACTIP HIGH POWER SINGLE-USE LASER FIBER
• 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: 14048431
• Report Number: 3005099803-2022-01916
• Device Sequence Number: 5555004
• Product Code: GEX
• UDI-Device Identifier: 08714729808176
• UDI-Public: 08714729808176
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2022

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: 07/13/2024
• Device Model Number: M0068403961
• Device Catalogue Number: 840-396
• Device Lot Number: 0000011349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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