MAUDE Adverse Event Report: BRIVANT LIMITED HI-TORQUE CONNECT 250T,30G,195

Model Number	901022-08
Medical Device Problem Codes	Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation underway.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, chronic total occlusion in the superficial femoral artery (sfa).This was a very difficult case and the thrombosed area was very crusty.During use, two connect guide wires experienced resistance with the anatomy during advancement.Both guide wires separated and frayed and broke off and there was also resistance during removal of both guide wires.The second guide wire likely had the tip caught on calcified plaque.The separated portions were retrieved and nothing remained in the patient.During preparation of the armada 18 percutaneous transluminal angioplasty (pta) catheter, a leak was suspected as there was air going into the syringe when pulling the syringe back to fill with contrast.Another armada 14 pta catheter was used to continue the procedure; however, the lesion could not be treated due to a failure to cross of an unspecified device.There were no reported adverse patient sequela.There was no reported clinically significant delay in the procedure.No additional information was provided.
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 heavily calcified, chronic total occlusion in the superficial femoral artery (sfa).This was a very difficult case and the thrombosed area was very crusty.During use, two connect guide wires experienced resistance with the anatomy during advancement.Both guide wires separated and frayed and broke off and there was also resistance during removal of both guide wires.The second guide wire likely had the tip caught on calcified plaque.The separated portions were retrieved and nothing remained in the patient.During preparation of the armada 18 percutaneous transluminal angioplasty (pta) catheter, a leak was suspected as there was air going into the syringe when pulling the syringe back to fill with contrast.Another armada 14 pta catheter was used to continue the procedure; however, the lesion could not be treated due to a failure to cross of an unspecified device.There were no reported adverse patient sequela.There was no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HI-TORQUE CONNECT 250T,30G,195
• Common Device Name: HI-TORQUE CONNECT 250T,30G,195
• 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: 14826577
• Report Number: 3006010712-2022-00025
• Device Sequence Number: 14663784
• Product Code: DQX
• UDI-Device Identifier: 08717648175046
• UDI-Public: 08717648175046
• 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): 07/28/2022

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: 10/31/2023
• Device Model Number: 901022-08
• Device Catalogue Number: 1012594
• Device Lot Number: 6119240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2020
• 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