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

Model Number	395613
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: pma/510(k): premarket submission number not available/not released.Zoll has not received the guidewire in complaint for investigation.A follow-up report will be submitted if and when the product is returned, and an investigation has been completed.
Event or Problem Description
The quattro catheter (lot # 208953) was smoothly inserted into the patient's right femoral vein.After the insertion, the customer was unable to retract the guidewire to remove it.Therefore, the physician had to remove both the catheter and the guidewire.A new catheter kit was used and inserted without problems.There were no complaints or issues with the catheter.No patient injury was reported.No consequences or impacts on the patient.
Additional Manufacturer Narrative
Section d4 suspect medical device, lot # was corrected.
Additional Manufacturer Narrative
Sections d2, d9, and h4 were updated.The reported complaint regarding difficulty retracting the guidewire was confirmed during visual inspection.The returned guidewire was observed to be kinked with several bends along its length.The probable root cause could be user handling.The guidewire was returned inside the catheter.The guidewire was able to be removed from the catheter.The guidewire had one kink and three bends along its length.Further testing could not be performed due to the condition in which the guidewire was received.Historical complaints were reviewed for investigation results related to the reported complaint, and there was no previous history of complaints reported for the guidewire with lot number 10237110.

• 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: 23597822
• Report Number: 3010617000-2025-00800
• Device Sequence Number: 10291295
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2026

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: 395613
• Device Catalogue Number: 395613
• Device Lot Number: 10237110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 11/21/2025; 12/26/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/10/2025; 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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