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

Model Number	M006L8405911
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.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 or Problem Description
It was reported to boston scientific corporation that a flexiva pulse laser fiber was used during a laser lithotripsy procedure of the kidney to treat a kidney stone on (b)(6) 2021.During the procedure, the fiber body overheated and began smoking at the end of the fiber connector.The laser fiber was immediately removed.The procedure was completed with another flexiva pulse laser fiber.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a flexiva pulse laser fiber was used during a laser lithotripsy procedure of the kidney to treat a kidney stone on (b)(6) 2021.During the procedure, the fiber body overheated and began smoking at the end of the fiber connector.The laser fiber was immediately removed.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: device code a1005 captures the reportable event of fiber overheated.Block h10: product investigation results: the returned flexiva pulse 242 laser fiber was analyzed, and a visual evaluation noted that the laser fiber was returned in one piece.The fiber measured 314 cm from the tip of the sma connector to the distal end of the distal tip.The exposed glass tip measured 2 mm and appeared degraded.Examination under magnification confirmed the pattern of the tip was consistent with normal degradation.A functional evaluation revealed that the light from the sma connector was distorted, indicating a fracture within the connector.No other problems with the device were noted.The reported event of fiber overheated was confirmed.It is likely that procedural handling of the fiber during set up or use contributed to the fracture within the fiber connector.A broken fiber within the connector of the device can result in insufficient aiming beam and low laser energy output, up to a complete inability for the fiber to fire, and the fiber connector may be hot to touch.Based on all available information, 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: 13239523
• Report Number: 3005099803-2021-08224
• Device Sequence Number: 4330552
• Product Code: GEX
• UDI-Device Identifier: 08714729978626
• UDI-Public: 08714729978626
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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): 02/24/2022

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: 05/23/2024
• Device Model Number: M006L8405911
• Device Catalogue Number: 2130-01
• Device Lot Number: 0027366976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2021
• 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: Female