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

Model Number	M006L8406911
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation on may 9, 2022 that a flexiva pulse id laser fiber was used in procedure performed on (b)(6) 2022.During the procedure, the lase fiber broke.There were no patient complications reported as a result of this event.
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.
Additional Manufacturer Narrative
Block h2: blocks b5, e1 & e3 have been updated with additional information received on (b)(6), 2022.Block h6: medical device problem code a0401 captures the reportable event of fiber break.Block h10: investigation results the returned flexiva pulse id laser fiber was analyzed, and a visual evaluation noted that the laser fiber was returned in two pieces.The first piece measure 9 cm.The second piece measured 319.9 cm.The exposed glass tip measured 1 mm and had normal degradation.A functional evaluation revealed that the light from the sma connector was distorted, indicating a fracture within the connector.The first piece one of the laser fiber was the sma connector boot while the second piece was the fiber body.No other problems with the device were noted.The reported event of the flexiva pulse id laser fiber break was confirmed.It is likely that procedural handling of the fiber during set-up or use contributed to the fracture within the fiber connector and fiber body separation from the sma connector.A fracture 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.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 9, 2022 that a flexiva pulse id laser fiber was used in procedure performed on (b)(6), 2022.During the procedure, the lase fiber broke.There were no patient complications reported as a result of this event.**additional information received on (b)(6), 2022** it was reported to boston scientific corporation on (b)(6), 2022 that a flexiva pulse id laser fiber was used in a ureteroscopy laser lithotripsy procedure for a stone treatment in a ureter performed on (b)(6), 2022.The laser unit used was a 100 watt laser console with the laser settings of 0.4 joules and 53 hertz.During the procedure, the lase fiber broke.No fiber fragments fell inside the patient.The procedure was completed with another flexiva pulse id laser fiber.There were no patient complications reported as a result of this event.

• Brand Name: FLEXIVA PULSE ID
• 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: 14592477
• Report Number: 3005099803-2022-03004
• Device Sequence Number: 1996748
• Product Code: GEX
• UDI-Device Identifier: 08714729978725
• UDI-Public: 08714729978725
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 06/23/2022

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: 03/17/2025
• Device Model Number: M006L8406911
• Device Catalogue Number: 2130-02
• Device Lot Number: 0029065746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2022
• 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