MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. GUIDEWIRE; CARDIAC/PERIPHERAL VASCULAR GUIDEWIRE, SINGLE-USE

Model Number	395613
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: pma/510(k): premarket submission number not available/not released.The guidewire associated with this complaint was discarded by the customer.Since the device was not returned, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
At the start of ivtm therapy, the patient's temperature was 30°c, with a target of 36.5°c for controlled hypothermia.While the quattro catheter (lot #unknown) was inserted into the patient's right femoral vein, the customer reported difficulty removing the guidewire.The guidewire could not be pulled out, was completely stretched, and visually became spiral.Despite this, the experienced senior icu physician extracted the guidewire and proceeded with the therapy using the quattro catheter.The customer reported no malfunctions or issues with the catheter.The patient was sedated and ventilated.No patient injury was reported.

• Brand Name: GUIDEWIRE
• Common Device Name: CARDIAC/PERIPHERAL VASCULAR GUIDEWIRE, SINGLE-USE
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 7800 dallas pkwy; ste. 200; plano TX 75024
• Manufacturer (Section G): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 20730323
• Report Number: 3010617000-2024-00950
• Device Sequence Number: 8922817
• Product Code: DQX
• UDI-Device Identifier: 00886333211753
• UDI-Public: 00886333211753
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2024

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
• Device Model Number: 395613
• Device Catalogue Number: 395613
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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