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

Model Number	M0068403960
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A flexiva tractip laser fiber was returned to boston scientific corporation.This product was returned to the manufacturer without any report of performance issues or adverse patient effects.The device was analyzed and the investigation results revealed that the laser fiber was broken within the connector.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number.Therefore, the manufacture date and expiration date are unknown.(b)(4).Investigation results: the returned flexiva tractip laser fiber was analyzed, and a visual evaluation noted that the laser fiber was returned in one piece.The laser fiber body measured 312.5 cm from the distal tip to the proximal end of 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 connector.No other problems with the device were noted.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 was unable to be performed as lot number is unknown.However, a ship history review was performed to identify the most probable lots and a manufacturing review of the most probable lots did not identify any anomalies or deviations that could have contributed to the event.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 TRACTIP
• 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: 14569281
• Report Number: 3005099803-2022-03003
• Device Sequence Number: 5774273
• Product Code: GEX
• UDI-Device Identifier: 08714729808169
• UDI-Public: 08714729808169
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110685
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2022

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 Model Number: M0068403960
• Device Catalogue Number: 840-396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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