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

Model Number	M0068F64520
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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) 2018 that a lighttrail 365um single use laser fiber was used during a laser lithotripsy procedure in the ureter performed on (b)(6) 2018.Reportedly, the laser unit used was an auriga xl 4007 console with laser settings of 1 j and 12 hz.According to the complainant, during the procedure, the tip of the laser fiber detached inside the patient upon laser activation.Reportedly, no fiber fragments fell inside the patient.The procedure was completed with a different device.There were no 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 december 3, 2018 that a lighttrail 365um single use laser fiber was used during a laser lithotripsy procedure in the ureter performed on (b)(6) 2018.Reportedly, the laser unit used was an auriga xl 4007 console with laser settings of 1 j and 12 hz.According to the complainant, during the procedure, the tip of the laser fiber detached inside the patient upon laser activation.Reportedly, no fiber fragments fell inside the patient.The procedure was completed with a different device.There were no 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
Initial reporter address 1 (b)(6).Problem code 2907 captures the reportable event of fiber tip detached.Investigation results: a lighttrail 365um single use laser fiber was returned broken.The fiber measured approximately 154.4 cm from the top of the connector to the break.The remainder of the fiber, including the distal tip, was not returned.The returned device was analyzed as broken.Review and analysis of all available information indicated that the damage to the device is likely a result of handling during setup of the device as it interacted with a scope.Therefore the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed; no anomalies were noted.

• 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: 8199333
• Report Number: 3005099803-2018-62176
• Device Sequence Number: 117209
• Product Code: GEX
• UDI-Device Identifier: 08714729939771
• UDI-Public: 08714729939771
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 03/06/2019

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: 08/27/2020
• Device Model Number: M0068F64520
• Device Catalogue Number: 69267
• Device Lot Number: 0022691513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1