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	11/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device has been disposed and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on november 30, 2018 that a lighttrail single use 230um laser fiber was used during a lithotripsy procedure in the kidney performed on (b)(6) 2018.According to the complainant, during the procedure the laser fiber was plugged into the laser and inserted through a ureteroscope.After 5 minutes into the procedure, the glass tip of the laser fiber broke off inside the patient's kidney.The surgeon used a nitinol basket to retrieve the glass tip and was successful without and harm to the patient.The procedure was completed with another laser fiber.There were no adverse patients effects as a result of this event.

• 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: 8187073
• Report Number: 3005099803-2018-62162
• Device Sequence Number: 11137558
• Product Code: GEX
• UDI-Device Identifier: 08714729939764
• UDI-Public: 08714729939764
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 12/20/2018

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: 12/04/2019
• Device Model Number: M0068F64500
• Device Catalogue Number: 69267
• Device Lot Number: 0022562718
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention