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

Model Number	901022-06
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
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 that the procedure was to treat a lesion located in the superficial femoral artery that was restenosed and non calcified.A connect flex wire tip broke off in the right sfa in the non-abbott stent occlusion (previously implanted in a separate procedure at an unknown date).The procedure was delayed for an hour as he had to use a snare to retrieve the broken piece.There was resistance in the lesion while trying to cross it and come apart due to resistance during withdrawal.The procedure was completed by crossing with a different wire where they then layered the in-stent area and used a drug coated balloon.The patient was successfully treated with no adverse sequela.No additional information was provided.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the superficial femoral artery that was restenosed and non calcified.A connect flex wire tip broke off off in the right sfa in the non-abbott stent occlusion (previously implanted in a separate procedure at an unknown date).The procedure was delayed for an hour as he had to use a snare to retrieve the broken piece.There was resistance in the lesion while trying to cross it and come apart due to resistance during withdrawal.The procedure was completed by crossing with a different wire where they then layered the in-stent area and used a drug coated balloon.The patient was successfully treated with no advese sequela.No additional information was provided.
Additional Manufacturer Narrative
Complaint investigation is attached to this report.

• 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: 16536964
• Report Number: 3006010712-2023-00011
• Device Sequence Number: 6325473
• 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): 04/19/2023

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: 03/31/2023
• Device Model Number: 901022-06
• Device Catalogue Number: 1012592
• Device Lot Number: 5771223
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2020
• 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