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

Model Number	M0068F64520
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	12/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional physician reported to be dr.(b)(6).(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 (b)(6) 2021 that a lighttrail single use 365um laser fiber was used in a ureteroscopy procedure performed on (b)(6) 2020.Reportedly, the laser unit used was a dornier laser console.According to the complainant, during the procedure, the fiber tip broke off.Reportedly, the fiber tip fell inside the patient's body and was unable to be retrieved.Since the physician did not think the fiber tip would pass naturally the patient was referred to a different doctor at a different hospital to remove the fiber tip at a later date.It is unknown if the procedure to remove the fiber tip has been performed.There were no patient complications reported 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: 11278423
• Report Number: 3005099803-2021-00364
• Device Sequence Number: 2737503
• Product Code: GEX
• UDI-Device Identifier: 08714729939771
• UDI-Public: 08714729939771
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2021

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: 09/21/2022
• Device Model Number: M0068F64520
• Device Catalogue Number: 6452
• Device Lot Number: 0026392450
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 02/04/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention