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

Model Number M0068F64650

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2024

Event Type  malfunction  

Event Description

It was reported that at the end of a lithotripsy procedure, the laser fiber tip broke in the kidney.A break in the fiber body was also identified.The procedure was completed by retrieving the broken tip piranha grasping forceps.There were no patient complications reported.

Manufacturer Narrative

There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.However, media analysis was provided, and it was possible to confirm that the fiber tip was broken.The device history review (dhr) confirmed that the device met all material, assembly and performance specifications.It is possible that an excess of force and overhandling were applied to the device, causing the reported fiber tip broken.Based on analysis results, without proper evaluation of the device, it remains unknown the most probable cause that contributed to the event, therefore, a conclusion code of cause not established was assigned to this investigation.Correction to model number.

Event Description

It was reported that at the end of the procedure during removal, the laser fiber tip was found to be broken in the patient's kidney.The procedure was completed by retrieving the broken tip piranha grasping forceps.There were no patient complications reported.

• Brand Name: LIGHTTRAIL TRACTIP
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19141227
• MDR Text Key: 340590608
• Report Number: 2124215-2024-23827
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

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
• Device Operator: Health Professional
• Device Model Number: M0068F64650
• Device Catalogue Number: 6465
• Device Lot Number: 0033136467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1