MAUDE Adverse Event Report: GALT MEDICAL CORP. GUIDEWIRE

Lot Number	S23194505
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
I was placing a picc [peripherally inserted central catheter] line, and i had gained access and used my guidewire to maintain access in the vein.After i introduced the vein, i removed my guidewire, and i noticed that the wire was not intact at the end.I was able to see that the wire was bunched but the tip was still holding.When i placed the line, it was completely smooth with no threading issues to note.The line threaded without issues, and i informed the np [nurse practitioner] and nothing was noted on the chest x-ray.The line was placed without issues, and i saved the wire and the packaging of the wire but not the introducer.

• 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: 22092144
• Report Number: 1649395-2025-00004
• Device Sequence Number: 7866666
• Product Code: DQX
• UDI-Device Identifier: 00841268100862
• UDI-Public: 00841268100862
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K982559
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/01/2025

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
• Device Lot Number: S23194505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (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 Age: 3 MO
• Patient Sex: Female