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

Model Number	M006L8405961
Medical Device Problem Codes	Overheating of Device (1437); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a flexiva pulse laser fiber was used during a laser lithotripsy procedure to treat stones in the kidney, performed on (b)(6) 2022.The laser unit used was a lumenis 100 watt laser console.During the procedure, the laser fiber was connected to the laser console and it started smoking.There was no reported burn injury to the user or to the patient.The procedure was completed with another flexiva pulse laser fiber.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).Investigation results: the returned flexiva pulse laser fiber was analyzed, and a visual evaluation noted that the laser fiber was returned in two pieces.The first piece measured 318.3 cm.The second piece measured 12.5 cm.The whole sma connector was separated from the fiber body.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 fracture within the connector.No other problems with the device were noted.The reported event of the flexiva pulse laser fiber smoking within the connector was confirmed.There was no light present from the sma connector, indicating that there was a fracture within the connector, confirming the event.It is likely that the prolong use of the device or condition of the stones caused the overheating.The device overheating lead to the fracture with in the sma connector and separation of the sma connector from the fiber body.Additionally, the ifu states, take caution.In the event of no output energy, the laser fiber connector hub 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.

• Brand Name: FLEXIVA PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14631652
• Report Number: 3005099803-2022-02981
• Device Sequence Number: 17673653
• Product Code: GEX
• UDI-Device Identifier: 08714729978664
• UDI-Public: 08714729978664
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K210925
• 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
• Report Date (Section B): 06/08/2022

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: 09/02/2024
• Device Model Number: M006L8405961
• Device Catalogue Number: 2130-01
• Device Lot Number: 0027960001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2021
• 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