MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LIGHTTRAIL SINGLE USE; POWERED LASER SURGICAL INSTRUMENT

Model Number	M0068F64500
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.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) 2019 that a lighttrail 230um laser fiber was used during a ureteroscopy procedure in the ureter performed on (b)(6) 2019.Reportedly, the laser unit used was an auriga 30 console.According to the complainant, during the procedure, the tip of the laser fiber detached inside the patient.Reportedly, the broken tip will be out passed naturally.The procedure was completed with the original device.There were no serious injury nor adverse patient effects reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6), 2019 that a lighttrail 230um laser fiber was used during a ureteroscopy procedure in the ureter performed on (b)(6), 2019.Reportedly, the laser unit used was an auriga 30 console.According to the complainant, during the procedure, the tip of the laser fiber detached inside the patient.Reportedly, the broken tip will be out passed naturally.The procedure was completed with the original device.There were no serious injury nor adverse patient effects reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Problem code 2907 captures the reportable event of fiber tip detached.Investigation results: one lighttrail single use 230um laser fiber was returned in one piece with the tip detached.The piece measured approximately 309.4 cm from the top of the connector to the distal tip.Exposed glass portion of the distal tip measured approximately 0.5 mm and was consistent with a fractured.The remainder of the tip was not returned.The condition of the returned device confirmed that the fiber tip was detached.Review and analysis of all available information indicated that the cause code for this event is adverse event related to procedure.A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during the procedure and the device had no influence on event.A dhr (device history record) review was performed and the device met all manufacturing specifications.

• Brand Name: LIGHTTRAIL SINGLE USE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8568430
• Report Number: 3005099803-2019-02249
• Device Sequence Number: 16603440
• Product Code: GEX
• UDI-Device Identifier: 08714729939764
• UDI-Public: 08714729939764
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K111475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

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: 01/11/2020
• Device Model Number: M0068F64500
• Device Catalogue Number: 69267
• Device Lot Number: 0023268683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1