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

Model Number	M0068403910
Medical Device Problem Codes	Break (1069); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results.The returned flexiva laser fiber was analyzed, and a visual evaluation noted that the laser fiber was returned in one piece.The fiber body measured 316.9 cm from the distal tip to the proximal end of the sma connector.The exposed glass tip measured 4 mm and appeared in good condition.A functional evaluation revealed that there was no light from the sma connector, indicating that there was a fracture within the connector.No other problems with the device were noted.The reported event of the flexiva laser fiber had a decrease of brightness was confirmed.The reported event of laser fiber had a decrease of brightness is consistent with a fiber broken within the connector.It is likely that procedural handling of the device 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.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) 2021 that a flexiva laser fiber was used in a ureterolithotripsy procedure to treat kidney stones in the kidney, performed on (b)(6) 2021.The laser settings used was 800 joules with a frequency of 8 and a density of 1200hu.During the procedure, after 15 seconds of use, the laser fiber had a decrease in brightness until it no longer fragmented the renal calculus.The procedure was completed with another flexiva laser fiber.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.Note: this event has been deemed reportable based on the investigation finding of laser fiber broken within the connector.

• Brand Name: FLEXIVA
• 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: 14428218
• Report Number: 3005099803-2022-02605
• Device Sequence Number: 6466049
• Product Code: GEX
• UDI-Device Identifier: 08714729808145
• UDI-Public: 08714729808145
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K100078
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2022

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: 02/16/2024
• Device Model Number: M0068403910
• Device Catalogue Number: 840-391
• Device Lot Number: 0000010605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2021
• 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: Male
• Patient Weight: 120 KG