MAUDE Adverse Event Report: BRIVANT LIMITED HI-TORQUE CONNECT FLEX, 12G,300

Model Number	901022-06
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
It was reported that the procedure was to treat a posterior tibial artery.During an attempt to recanalize the posterior tibial artery, the tip of the 018 ht connect flex guide wire (gw) separated in the anatomy.The guide wire was removed with resistance.A snare was used to remove the tip from the anatomy.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.A non-abbott guide wire and armada balloon dilatation catheter (bdc) were used to successfully compete the procedure.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
It was reported that the procedure was to treat a posterior tibial artery.During an attempt to recanalize the posterior tibial artery, the tip of the 018 ht connect flex guide wire (gw) separated in the anatomy.The guide wire was removed with resistance.A snare was used to remove the tip from the anatomy.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.A non-abbott guide wire and armada balloon dilatation catheter (bdc) were used to successfully compete the procedure.

• Brand Name: HI-TORQUE CONNECT FLEX, 12G,300
• Common Device Name: HI-TORQUE CONNECT FLEX, 12G,300
• Manufacturer (Section D): BRIVANT LIMITED; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer (Section G): BRIVANT LIMITED; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer Contact: jaseem saqib ; parkmore west business park; galway, H91 C-K22 ; EI H91 CK22
• MDR Report Key: 15368459
• Report Number: 3006010712-2022-00039
• Device Sequence Number: 20402531
• Product Code: DQX
• UDI-Device Identifier: 08717648175022
• UDI-Public: 08717648175022
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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: 01/31/2025
• Device Model Number: 901022-06
• Device Catalogue Number: 1012592
• Device Lot Number: 6958778
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown