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)
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 customer reported an issue with advancing the quattro catheter (lot # 200089) and retracting the guidewire during catheter insertion into a patient's femoral vein.The guidewire became stuck and could not be removed, so both the catheter and guidewire were taken out together without any surgical intervention or issues.A new guidewire was used to insert a replacement catheter at the same insertion site.This incident occurred in the past and was not reported to zoll at the time.Unfortunately, the attending physician no longer recalls which patient it was, only that the patient had died from another cause.The customer suspects that there was a tighter bend in the vessel, which made it somewhat more difficult to advance the catheter and remove the guidewire.No patient injury related to the zoll device was reported.
Event or Problem Description
The customer reported an issue with advancing the quattro catheter (lot # 198225) and retracting the guidewire during catheter insertion into a patient's femoral vein.The guidewire became stuck and could not be removed, so both the catheter and guidewire were taken out together without any surgical intervention or issues.A new guidewire was used to insert a replacement catheter at the same insertion site.This incident occurred in the past and was not reported to zoll at the time.Unfortunately, the attending physician no longer recalls which patient it was, only that the patient had died from another cause.The customer suspects that there was a tighter bend in the vessel, which made it somewhat more difficult to advance the catheter and remove the guidewire.No patient injury related to the zoll device was reported.
Additional Manufacturer Narrative
Section b5 was corrected with the updated lot number.Sections d2, d9, and h4 were updated.The reported complaint of an issue with retracting the guidewire was confirmed.The guidewire was returned stuck inside the catheter and was completely damaged, with several kinks and bends observed along its length.The probable root cause could be related to the insertion or removal process of the guidewire.During the visual inspection of the returned guidewire, it was found stuck inside the catheter and could not be removed from the proximal end of the distal luer port.To remove the guidewire, it had to be pulled out from the catheter tip.The guidewire was completely damaged, with kinks and bends located at 10 inches, 8 inches from the j hook, and at the distal end of the j hook.Further testing could not be performed due to the condition in which the guidewire was received.Historical complaints were reviewed for investigation result related to the reported complaint, and there was no previous history of complaints reported for the guidewire with lot number 198225.

• 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: 21044636
• Report Number: 3010617000-2024-01043
• Device Sequence Number: 8654429
• Product Code: DQX
• UDI-Device Identifier: 00886333211753
• UDI-Public: 00886333211753
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 02/03/2025

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: 01/29/2026
• Device Model Number: 395613
• Device Catalogue Number: 395613
• Device Lot Number: 198225
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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