MAUDE Adverse Event Report: LAKE REGION MEDICAL HI-TORQUE CONNECT FLEX,12G,300

Model Number	901022-06
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
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 the procedure was to treat the superficial femoral artery popliteal with laser atherectomy.During the procedure via angiogram visualization, the 018 ht connect flex guide wire polymer was noted to be frayed.A new connect flex guide wire was used and the same issue occurred.A non-abbott wire was used to complete the procedure.No coating was left in the anatomy.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.
Additional Manufacturer Narrative
Complaint investigation is attached to this report.
Event or Problem Description
It was reported the procedure was to treat the superficial femoral artery popliteal with laser atherectomy.During the procedure via angiogram visualization, the 018 ht connect flex guide wire polymer was noted to be frayed.A new connect flex guide wire was used and the same issue occurred.A non-abbott wire was used to complete the procedure.No coating was left in the anatomy.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.

• Brand Name: HI-TORQUE CONNECT FLEX,12G,300
• Common Device Name: HI-TORQUE CONNECT FLEX,12G,300
• Manufacturer (Section D): LAKE REGION MEDICAL; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer (Section G): LAKE REGION MEDICAL; 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: 17681143
• Report Number: 3006010712-2023-00043
• Device Sequence Number: 14997410
• 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): 10/19/2023

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: 10/31/2025
• Device Model Number: 901022-06
• Device Catalogue Number: 1012592
• Device Lot Number: 7634962
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2022
• 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