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

Model Number	M0068403961
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a flexiva tractip high power single use laser fiber was used during a ureteroscopy procedure to treat a stone in the ureter performed on (b)(6) 2022.During the procedure, the tip of the laser fiber broke inside the patient.The laser fiber tip was successfully retrieved.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
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.
Additional Manufacturer Narrative
Block h6: medical device problem code a0501 captures the reportable event of fiber tip detached.Impact code f23 captures the reportable event of unexpected medical intervention.Block h10: investigation results: the returned flexiva tractip high power single-use laser fiber was analyzed, and a visual evaluation noted that the laser fiber was returned in one piece.The fiber body measured 314.1 cm from the distal tip to the proximal end of the sma connector.The exposed glass tip measured 1 mm and was detached.A functional evaluation revealed that the light from the sma connector was bright and round, indicating that there was no fracture within the connector.No other problems with the device were noted.The reported event of the tip detachment of device or device component was confirmed.It is likely that procedural handling of the device during set-up or use contributed to the ball tip detachment.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), 2022 that a flexiva tractip high power single use laser fiber was used during a ureteroscopy procedure to treat a stone in the ureter, performed on (b)(6), 2022.During the procedure, the tip of the laser fiber broke inside the patient.The laser fiber tip was successfully retrieved.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

• Brand Name: FLEXIVA (TM) 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
• 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: 13870711
• Report Number: 3005099803-2022-01577
• Device Sequence Number: 17309795
• Product Code: GEX
• UDI-Device Identifier: 08714729808176
• UDI-Public: 08714729808176
• 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,Followup
• Report Date (Section B): 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: M0068403961
• Device Catalogue Number: 840-396
• Device Lot Number: 0000011529
• 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: 03/03/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown