MAUDE Adverse Event Report: GALT MEDDICAL CORP GALT STERILE GUIDEWIRE; NITI STAINLESS STEEL STERILE GUIDEWIRE

Model Number	SGW-019-40
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device did not return to manufacturer for evaluation yet.Investigation performed on device history review of main sterile product and all subcomponents as well.Documentation shows there are no incidents or abnormality indicated during manufacturing of gwa-019-40.All parts manufactured to specification and pass inspections.A follow up report will be sent to fda once complaint sample returned to manufacturer and after completion of investigation and evaluations.
Event or Problem Description
As received by the customer from end user (this picc rn was placing a picc line in patient's right upper arm (brachial vein).Accessed vessel with 24g angiocath, had brisk blood return, placed an.014 nitinol guidewire through angiocath into vessel.Nitinol guidewire advanced 10 cm without any difficulty or resistance.Dilator was placed over the guidewire and advanced into the vessel without any difficulties.Picc line was then placed over the guidewire through the dilator.Was only able to advance picc line about 8 cm and then felt resistance.Obtained cxr.Showed picc line in subclavian vein curled back on itself slightly.Could not straighten picc or guidewire out.Decision made to remove picc and guidewire and to attempt 0.14 guidewire instead.Upon removing guidewire, it was noted that the guidewire was unraveling).

• Brand Name: GALT STERILE GUIDEWIRE
• Common Device Name: NITI STAINLESS STEEL STERILE GUIDEWIRE
• Manufacturer (Section D): GALT MEDDICAL CORP; 2220 merritt dr #100; garland TX 75041
• Manufacturer (Section G): GALT MEDICAL CORP.; 2220 merritt dr #100; garland TX 75041
• Manufacturer Contact: diyar medhat ; 2220 merritt dr #100; garland, TX 75041 ; 9722715177
• MDR Report Key: 16524841
• Report Number: 1649395-2023-00004
• Device Sequence Number: 2315837
• Product Code: DQX
• UDI-Device Identifier: 10841268100869
• UDI-Public: 10841268100869
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K021990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/10/2023

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 Expiration Date: 09/13/2026
• Device Model Number: SGW-019-40
• Device Lot Number: S22322549
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown