MAUDE Adverse Event Report: LAKE REGION MEDICAL HI-TORQUE CONNECT,4G,195

Model Number	901022-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis as it was discarded; therefore, limited investigation was carried out.No sample retain of the same lot number was available.The device lot history records have been reviewed, and it is shown that there were no anomalies or non-conformance raised that could have contributed to the reported failure mode and that the guidewires were manufactured according to the specification.All the required relevant tests and inspections were performed and passed.The risk traceability matrix number rmf(tm)-008 was reviewed and it was found that the risk for this failure mode was included and well documented.The current rating for the failure mode in question is within the expected levels for the confirmed complaints.There is no evidence to suggest that the design of the guidewire or any manufacturing-related concerns has contributed to the incident as well as the device was not returned for investigation, thus the complaint cause cannot be verified.
Event or Problem Description
It was reported that percutaneous venous balloon dilatation was performed.The tip of the connect guide wire was noted to be damaged.The guide wire was replaced to complete the procedure.There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported that percutaneous venous balloon dilatation was performed.The tip of the connect guide wire was noted to be damaged.The guide wire was replaced to complete the procedure.There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HI-TORQUE CONNECT,4G,195
• Common Device Name: HI-TORQUE CONNECT,4G,195
• Manufacturer (Section D): LAKE REGION MEDICAL; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer Contact: amy carter ; parkmore west business park,; galway, H91 C-K22 ; EI H91 CK22
• MDR Report Key: 19517252
• Report Number: 3006010712-2024-00029
• Device Sequence Number: 12304887
• Product Code: DQX
• UDI-Device Identifier: 08717648174988
• UDI-Public: 08717648174988
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112381
• Number of Events Summarized: 1
• Summary Report (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): 06/12/2024

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 Model Number: 901022-02
• Device Catalogue Number: 1012588
• Device Lot Number: 8505305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• 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