LIGHTTRAIL REUSABLE M0068F64630 69266

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for LIGHTTRAIL REUSABLE M0068F64630 69266 manufactured by Boston Scientific Corporation.

Event Text Entries

[185199645] (b)(4). The returned lighttrail reusable 270um laser fiber was analyzed, and a visual evaluation noted that it was returned in one piece. The fiber measured approximately 309. 3 cm from the top of the connector to the tip. The exposed glass portion of the tip measured approximately 1 mm and appeared fractured. Examination under magnification confirmed the pattern on the tip was consistent with a fracture. The remainder of the tip was not returned. Visual examination revealed that light cannot travel well to the fiber face within the sma connector to illuminate it fully, indicating that the fiber was broken within the connector. It was likely that due to the fracture within the connector that the fiber would not fire during a procedure. Functional analysis revealed that when the fiber was connected to the auriga laser console, the attach fiber message disappeared indicating that the fiber was recognized by the console. The laser console displayed the message, applicator has been used 3 times. No other issues with the device were noted. The reported event was confirmed. Review and analysis of all available information indicated that the root cause 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 review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing. A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Patient Sequence No: 1, Text Type: N, H10


[185199646] It was reported to boston scientific corporation on january 4, 2020 that a lighttrail reusable 270um laser fiber was used in a lithotripsy procedure in the kidney performed on january 2, 2020. Reportedly, the laser unit used was an auriga xl 50 watt laser console. According to the complainant, during the procedure, upon pressing down the foot switch there was no laser energy from the laser fiber. The fiber did not release any laser beam although there was light. The procedure was completed with another lighttrail reusable 270um laser fiber. There were no patient complications reported as a result of this event. This event has been deemed a reportable event based on the investigation finding of the laser fiber broken within the connector and fiber tip detached.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2020-01243
MDR Report Key9882490
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-01-02
Date Mfgr Received2020-03-11
Device Manufacturer Date2019-06-14
Date Added to Maude2020-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactCAROLE MORLEY
Manufacturer Street300 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834015
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer StreetMODEL FARM ROAD CORK
Manufacturer CityCORK IRELAND
Manufacturer CountryEI
Manufacturer Postal CodeIRELAND
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLIGHTTRAIL REUSABLE
Generic NamePOWERED LASER SURGICAL INSTRUMENT
Product CodeGEX
Date Received2020-03-26
Returned To Mfg2020-03-06
Model NumberM0068F64630
Catalog Number69266
Lot Number0023953744
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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