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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results.The returned flexiva id tractip 200 laser fiber was analyzed, and a visual evaluation noted that it was returned in one piece.The fiber measured 308.4 cm from the end of the sma connector to the exposed glass tip.The exposed glass tip measured 4 mm and appeared in good condition.Functional analysis revealed that the light from the sma connector was distorted, which indicates a fracture within the fiber connector.No other problems with the device were noted.The reported event was confirmed.It is likely that procedural handling of the fiber during setup or use contributed to the fracture within the fiber connector, leading to the reported failure to fire.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.
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 ureteroscopy procedure in the kidney performed on (b)(6) 2021.The laser unit used was a lumenis 100 watt laser console.During the procedure, the laser fiber was not firing any energy from the tip.The laser fiber was screwed in all the way into the connector.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 information: this event has been deemed reportable based on the investigation finding that the laser fiber was broken within the connector.

• 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: 12594559
• Report Number: 3005099803-2021-05186
• Device Sequence Number: 14525540
• Product Code: GEX
• UDI-Device Identifier: 08714729963844
• UDI-Public: 08714729963844
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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: 03/30/2024
• Device Model Number: M006R8403961
• Device Catalogue Number: 69270
• Device Lot Number: 0000010854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2021
• Initial 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