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

Model Number	M006L8405920
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
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 june 10, 2022 that a flexiva pulse laser fiber was used during a ureteroscopy procedure to treat stones in the kidney, performed on (b)(6), 2022.The laser unit used was a lumenis versa pulse laser console.During to the procedure, the staff touched the laser fiber connector to disconnect and was surprised how hot the piece had become.The fiber connector was too hot to comfortably disconnect with bare skin touching the piece.Had to wait until it cooled.There was no burn injury to the operator.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
Block h6: medical device problem code a1005 captures the reportable event of fiber connector overheats.Block h10: investigation results: the returned flexiva pulse laser fiber was analyzed, and a visual evaluation noted that the laser fiber was returned in three pieces.The first piece measured 277.5 cm from the end of the fiber body to the exposed glass tip.The second piece measured 4.7 cm which is the sma boot and the third piece measured 3.5 cm which is the sma connector.The exposed glass tip measured 2 mm and had normal degradation.A functional evaluation revealed that the light from the sma connector was distorted, indicating that there was a fracture within the fiber connector.No other problems with the device were noted.The reported event of the flexiva pulse laser fiber connector overheats was confirmed.It is likely that procedural handling of the device during set-up or use contributed to the fracture within the fiber connector and the prolonged use of the device ultimately resulted in the device overheating and causing the sma connector to detach from the fiber body.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 (b)(6) 2022 that a flexiva pulse laser fiber was used during a ureteroscopy procedure to treat stones in the kidney, performed on (b)(6) 2022.The laser unit used was a lumenis versa pulse laser console.During to the procedure, the staff touched the laser fiber connector to disconnect and was surprised how hot the piece had become.The fiber connector was too hot to comfortably disconnect with bare skin touching the piece.Had to wait until it cooled.There was no burn injury to the operator.The procedure was completed with another flexiva pulse laser fiber.There were no patient complications reported as a result of this event.

• 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: 14874383
• Report Number: 3005099803-2022-03573
• Device Sequence Number: 17550642
• Product Code: GEX
• UDI-Device Identifier: 08714729978589
• UDI-Public: 08714729978589
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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,Followup
• Report Date (Section B): 08/05/2022

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: 04/07/2025
• Device Model Number: M006L8405920
• Device Catalogue Number: 2130-01
• Device Lot Number: 0029193440
• 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: 06/10/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2022
• 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