FDA Adverse Event Malfunction Summary report: N

LIGHTTRAIL TRACTIP

MDR report key: 7660937 · Received July 3, 2018

Report

Report Number: 3005099803-2018-02131
Event Type: Malfunction
Date Received: July 3, 2018
Date of Event: June 12, 2018
Report Date: June 13, 2018
Manufacturer: BOSTON SCIENTIFIC - MARLBOROUGH
Product Code: GEX
PMA / PMN Number: SIMILAR
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AU
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE EXACT PATIENT AGE IS UNKNOWN; HOWEVER THE PATIENT WAS REPORTED TO BE OVER THE AGE OF 18. DEVICE COMPONENT CODE RELATES TO DEVICE PROBLEM CODE FOR THE REPORTED EVENT OF FIBER TIP DETACHED. MFG. SITE NAME-AMERICAN MEDICAL SYSTEMS. 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.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A LIGHTTRAIL TRACTIP LASER FIBER WAS USED DURING A LASER TO STONE PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND OUTSIDE THE PATIENT, THE TIP OF THE LASER FIBER BROKE OFF UPON INSERTION INTO THE WORKING CHANNEL OF THE SCOPE. REPORTEDLY, NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL TRACTIP 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 FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
502100	LIGHTTRAIL TRACTIP	LASER INSTRUMENT, SURGICAL, POWERED	GEX	BOSTON SCIENTIFIC - MARLBOROUGH	M0068F64650	0021880289

Patients

Seq	Age	Sex	Outcome	Treatment
1