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

Model Number	395613
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released as it is exempt from premarket submission.The guidewire involved in the reported complaint will not be returned for investigation because the customer has disposed of it.Therefore, a physical investigation could not be performed, and the root cause could not be determined.
Event or Problem Description
During multiple attempts, the customer had difficulty removing the guidewire from the quattro catheter.Three quattro catheters and zoll guidewires were attempted to insert into the femoral vein (right and left sides).Each attempt was difficult and required multiple insertions.The customer reported that the guidewire could not be removed from any of the three catheters, and the catheter had to be removed along with the guidewire each time.Per the customer, the physician's experience with intravascular catheter placement was frequent, and per the physician, there was no increased tortuosity in the vein.No patient injury was reported.The customer saved only one catheter (lot #198059) with guidewire (lot #199681) for investigation.The lot numbers of the two other catheters and the guidewires are unknown, and the customer has disposed of them.

• 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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 20859357
• Report Number: 3010617000-2024-00956
• Device Sequence Number: 4058509
• 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): 12/05/2024

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: 12/05/2024
• 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