MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. GUIDEWIRE; PERIPHERAL VASCULAR GUIDEWIRE, MANUAL

Model Number	395539
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A 75-year-old male patient was hospitalized, and the need for ivtm therapy was to induce hypothermia post-cardiac arrest.The quattro catheter was inserted into the patient's right femoral vein.The insertion was difficult, and placing the catheter took multiple attempts (3 attempts).After the catheter insertion, the user had multiple problems removing the guidewire after the catheter placement.The user had to pull back the quattro catheter slightly to remove the guidewire.The ivtm therapy was initiated and continued with no further issues.No device malfunction was reported on the catheter.The patient is stable, and no patient injury was reported.
Additional Manufacturer Narrative
Zoll has received the guidewire for investigation.A follow-up report will be submitted when the investigation has been completed.
Event or Problem Description
A 75-year-old male patient was hospitalized, and the need for ivtm therapy was to induce hypothermia post-cardiac arrest.The quattro catheter was inserted into the patient's right femoral vein.The insertion was difficult, and placing the catheter took multiple attempts (3 attempts) by an experienced intensive care physician.After the catheter insertion, the user had multiple problems removing the guidewire after the catheter placement.The user had to pull back the quattro catheter slightly to remove the guidewire.The ivtm therapy was initiated and continued using the same quattro catheter without further issues.No device malfunction was reported on the catheter.The patient is stable, and no patient injury was reported.
Additional Manufacturer Narrative
The customer's complaint of difficulty removing the guidewire after the catheter placement was confirmed during the visual inspection of the returned guidewire.The guidewire was completely damaged.The guidewire was observed to have several bents and stretched wire along its length.The probable root cause could be a handling issue and/or insertion, removing the guidewire.Further testing could not be performed due to the condition in which the guidewire was received.
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released as it is exempt from premarket submission.

• Brand Name: GUIDEWIRE
• Common Device Name: PERIPHERAL VASCULAR GUIDEWIRE, MANUAL
• 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 nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18330945
• Report Number: 3010617000-2023-01031
• Device Sequence Number: 8416130
• Product Code: DQX
• UDI-Device Identifier: 00886333211678
• UDI-Public: 00886333211678
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K770977
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2024

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: 395539
• Device Catalogue Number: 395539
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 12/20/2023; 07/16/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/12/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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