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

Model Number	M0068403960
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
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 march 10, 2022 that a flexiva tractip laser fiber was used during a procedure, performed on (b)(6) 2022.During the procedure, when displayed on camera, the tip of the laser fiber appeared to be different from the usual ball-tip.The laser fiber was removed and cut, and the procedure was completed with the original flexiva tractip 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: although the flexiva laser fiber tip was found to be different from the usual ball-tip, the user chose to cut the fiber and continue use.The flexiva tractip laser fiber ifu directs the user to ensure the product is not damaged as part of device preparation and to not use the device if it is found damaged.
Additional Manufacturer Narrative
Block h6: medical device problem code a0406 captures the reportable event of tip/face deformation.Block h10: investigation results the returned flexiva tractip laser fiber was received for analysis.The exposed glass tip measured 4 mm and appeared to have normal degradation.The fiber body of the laser was not available.No other problems with the device were noted.The reported event of the flexiva tractip laser fiber tip/face material deformation was confirmed.Laser fibers are consumable devices and expected to degrade with use.It is likely that procedural handling and usage of the fiber resulted in normal fiber degradation.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 march 10, 2022 that a flexiva tractip laser fiber was used during a procedure, performed on (b)(6) 2022.During the procedure, when displayed on camera, the tip of the laser fiber appeared to be different from the usual ball-tip.The laser fiber was removed and cut, and the procedure was completed with the original flexiva tractip 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: although the flexiva laser fiber tip was found to be different from the usual ball-tip, the user chose to cut the fiber and continue use.The flexiva tractip laser fiber ifu directs the user to ensure the product is not damaged as part of device preparation and to not use the device if it is found damaged.

• 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: 13978345
• Report Number: 3005099803-2022-01765
• Device Sequence Number: 5995179
• Product Code: GEX
• UDI-Device Identifier: 08714729808169
• UDI-Public: 08714729808169
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: 06/24/2024
• Device Model Number: M0068403960
• Device Catalogue Number: 840-396
• Device Lot Number: 0000011273
• 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: 03/10/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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: Unknown