MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIVA (TM) ID TRACTIP HIGH POWER SINGLE-USE LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	M006R8403961
Medical Device Problem Codes	Overheating of Device (1437); Failure to Fire (2610)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This event was received via a voluntary medwatch report.The report number is 4600150000-2021-8003.Medical device problem code a1005 captures the reportable event of fiber connector overheats.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 on (b)(6) 2021 that a flexiva id tractip 200 laser fiber was used in a procedure performed on (b)(6) 2021.During the procedure, the laser fiber had no aiming beam and did not fire.The laser was unplugged and the end of the laser fiber was extremely hot.There was no burn injury to the user or to the patient.The procedure was completed with another flexiva id tractip 200 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 on july 27, 2021 that a flexiva id tractip 200 laser fiber was used in a procedure performed on (b)(6) 2021.During the procedure, the laser fiber had no aiming beam and did not fire.The laser was uplugged and the end of the laser fiber was extremely hot.There was no burn injury to the user or to the patient.The procedure was completed with another flexiva id tractip 200 laser fiber.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter address 1: (b)(6).Block g2: this event was received via a voluntary medwatch report.The report number is (b)(4).Block h6: medical device problem code a1005 captures the reportable event of fiber connector overheats.Block h10: investigation results the returned flexiva id tractip 200 laser fiber was analyzed, and a visual evaluation noted that it was returned in three pieces.The first piece was the sma connector and measured 2.7 cm.The second piece was the fiber body and measured 194 cm.The third piece measured 117.7 cm and included the exposed glass tip.The exposed glass tip measured 3 mm and appeared degraded.Examination under magnification confirmed the pattern of the tip was consistent with normal degradation.The sma boot was observed to have some melting where it was connected to the sma connector.The light from the sma connector could not be tested due to the condition of the fiber.No other problems with the device were noted.The reported event was confirmed.Fibers are consumable devices and intended to degrade with use.The observed condition of the fiber, sma connector detached and the sma boot damage, is indicative of a fracture within the fiber connector.However, due to the condition of the fiber, the fiber connector fracture was unable to be observed during analysis.It is likely that procedural handling of the device during set-up contributed or use to a 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.Additionally, the flexiva id tractip 200 the ifu states, in the event of reduced or no laser energy output during application the fiber connector may be hot to touch.Review and analysis of all available information indicated that the 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 (TM) ID TRACTIP HIGH POWER SINGLE-USE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12339723
• Report Number: 3005099803-2021-04267
• Device Sequence Number: 2754399
• Product Code: GEX
• UDI-Device Identifier: 08714729963844
• UDI-Public: 08714729963844
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2021

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: 03/29/2024
• Device Model Number: M006R8403961
• Device Catalogue Number: 69270
• Device Lot Number: 0000010848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1