MAUDE Adverse Event Report: GALT MEDICAL CORP. GUIDEWIRE

Lot Number	G24108663
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A mandril guidewire (sgw-056-02, lot # g24108663) was opened advanced through a 4f vascular sheath for picc exchange.The tip became lodged while traversing through the vasculature centrally.Some resistance was felt during attempt to gently retract the guidewire.The wire was then observed to be fractured.A portion of the guidewire detached upon removal, leaving a portion in the left basilic vein as confirmed with fluoroscopy.Foreign body retrieval: vascular snare deployed to retrieve guidewire fragment.Mostly successful, but a fragment still remained within the patient.Vascular stent deployed to exclude guidewire fragment from the patient's circulation.Angioplasty also performed.Ultimately, no change to patient care management.

• Brand Name: GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): GALT MEDICAL CORP.; 2220 merritt dr; garland TX 75041
• Manufacturer (Section G): GALT MEDICAL CORP; 2220 merritt dr; garland TX 75041
• Manufacturer Contact: david derrick ; 2220 merritt dr; garland, TX 75041 ; 2147781306
• MDR Report Key: 22136367
• Report Number: 1649395-2025-00006
• Device Sequence Number: 8354279
• Product Code: DQX
• UDI-Device Identifier: 00841268101425
• UDI-Public: 00841268101425
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: D013339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2025

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 Lot Number: G24108663
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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