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

Model Number	901022-06
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/18/2024
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 left pulmonary artery.When attempting to advance the cardiomems delivery system over the.018 connect flex guide wire resistance was felt and the system was not able to advance further.The wire and delivery system were removed.The guide wire was noted to have coating sheared off.A new.018 guidewire was used along with cardiomems device and the sensor was deployed successfully.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported that the procedure was to treat left pulmonary artery.When attempting to advance the cardiomems delivery system over the.018 connect flex guide wire resistance was felt and the system was not able to advance further.The wire and delivery system were removed.The guide wire was noted to have coating sheared off.A new.018 guidewire was used along with cardiomems device and the sensor was deployed successfully.There was no adverse patient sequela and no clinically significant delay in the procedure.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: 19674340
• Report Number: 3006010712-2024-00034
• Device Sequence Number: 7526989
• 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): 08/27/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2024
• Supplement Date Received by Manufacturer: 06/29/2024
• Initial Report FDA Received Date: 07/04/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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