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

Model Number	395539
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The guidewire involved in the reported complaint will not be returned for investigation because the customer has disposed of them.Event deemed serious by medical judgment (could lead to a life-threatening event).Event assessed as a causal relationship to the device.The placement was performed by an inexperienced physician.The use of intravascular guidewires for placement of any catheter has the potential for perforation if not placed correctly or placed by experienced personnel.There is no information regarding the location of perforation or patient details to assess further.Event is anticipated, perforation can occur as a complication of the usage of any catheter inserted in vein.The event's relationship to the device and procedure is causal.
Event or Problem Description
While inserting the guidewire into the patient's vein to initiate an ivtm treatment, the physician noticed that the guidewire penetrated a blood vessel.The physician tried to insert another guidewire, but it penetrated a blood vessel again.These insertion attempts caused injury to the patient's blood vessel.Per the reporter, the physician is inexperienced with intravascular catheter placement.The customer did not provide any further information regarding the insertion site(s) or how the treatment continued after the second penetration occurred.The customer did not provide information on the patient's current status.The two guidewires with lot numbers 188014 and 185168 were used in the reported event; however, it is unknown which guidewire was used first.Please see the following related mfr report: mfr #3010617000-2023-01060 for guidewire (lot #185168).
Additional Manufacturer Narrative
**udi related data quality updates only** 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: 18307724
• Report Number: 3010617000-2023-01061
• Device Sequence Number: 6267537
• Product Code: DQX
• UDI-Device Identifier: 00886333211678
• UDI-Public: 00886333211678
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 395539
• Device Catalogue Number: 395539
• Device Lot Number: 188014
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown