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

Model Number	M0068F64560
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2017
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
Note: this manufacturer report pertains to the one of two devices used in the same procedure.Refer to the associated manufacturer report numbers 3005099803-2018-00653 and 3005099803-2018-00654 for the other associated device information.It was reported to boston scientific corporation on february 13, 2018 that a lighttrail 800um single use laser fiber and lighttrail 600um single use laser fiber were used in a thulium laser ablation of the prostate procedure performed on (b)(6) 2017.According to the complainant, during the procedure and outside the patient, it was noted that the fiber tip broke off upon insertion into the cystoscope (captured in mfr.# 3005099803-2018-00653).A second lighttrail single use 600um laser fiber was opened and the same thing happened (captured in mfr.# 3005099803-2018-00654).Reportedly, the procedure was completed with the second lighttrail single use 600um laser fiber.There were no patient complications 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
Note: this manufacturer report pertains to the one of two devices used in the same procedure.Refer to the associated manufacturer report numbers 3005099803-2018-00653 and 3005099803-2018-00654 for the other associated device information.It was reported to boston scientific corporation on february 13, 2018 that a lighttrail 800um single use laser fiber and lighttrail 600um single use laser fiber were used in a thulium laser ablation of the prostate procedure performed on (b)(6) 2017.According to the complainant, during the procedure and outside the patient, it was noted that the fiber tip broke off upon insertion into the cystoscope (captured in mfr.# 3005099803-2018-00653).A second lighttrail single use 600um laser fiber was opened and the same thing happened (captured in mfr.# 3005099803-2018-00654).Reportedly, the procedure was completed with the second lighttrail single use 600um laser fiber.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
One lighttrail 800 m single use laser fiber was received for evaluation.Visual analysis revealed that the fiber was returned broken and measured approximately 309.5 cm from the top of the connector to the break.The remainder of the fiber including the distal tip was not returned.The condition of the returned device confirms the event.The noted damages indicate the complaint was caused by handling of the device or portion of the device without direct patient contact either during unpacking, preparation, or shipping; at the end of the procedure; or when packaging for return.Therefore, a review and analysis of all available information indicated that the most probable root cause is handling damage.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.

• Brand Name: LIGHTTRAIL SINGLE USE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7321393
• Report Number: 3005099803-2018-00653
• Device Sequence Number: 110147
• Product Code: GEX
• UDI-Device Identifier: 08714729939795
• UDI-Public: 08714729939795
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 02/13/2018

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: 08/21/2019
• Device Model Number: M0068F64560
• Device Lot Number: 0021177996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1