MAUDE Adverse Event Report: BRIVANT LTD. T/A LAKE REGION MEDICAL HI-TORQUE CONNECT 250T,30G,300

Model Number 901022-09

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/05/2020

Event Type  malfunction  

Manufacturer Narrative

Complaint investigation underway and will be attached to this report.

Event Description

It was reported that the procedure was to treat a heavily calcified mid to distal superficial femoral artery.When advancing a hi-torque connect guide wire, resistance was met with the highly calcified anatomy and the tip became separated.The tip was retrieved via snare.The patient status is fine and the physician deemed the procedure complete.There was no adverse patient sequela or clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

Complaint investigation underway and will be attached to this report.

Event Description

It was reported that the procedure was to treat a heavily calcified mid to distal superficial femoral artery.When advancing a hi-torque connect guide wire, resistance was met with the highly calcified anatomy and the tip became separated.The tip was retrieved via snare.The patient status is fine and the physician deemed the procedure complete.There was no adverse patient sequela or clinically significant delay reported.No additional information was provided.

• Brand Name: HI-TORQUE CONNECT 250T,30G,300
• Type of Device: HI-TORQUE CONNECT 250T,30G,300
• Manufacturer (Section D): BRIVANT LTD. T/A LAKE REGION MEDICAL; parkmore west business park; galway, ei ; EI
• MDR Report Key: 9828845
• MDR Text Key: 192038850
• Report Number: 3006010712-2020-00003
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K112381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 901022-09
• Device Catalogue Number: 1012595
• Device Lot Number: 4833577
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other