MAUDE Adverse Event Report: GALT MEDICAL CORP. MICRO-INTRODUCER KIT

Model Number	KIT-011-62
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During removal of the micro-puncture catheter, the proximal end of the catheter remained lodged within the av [arteriovenous] graft.An open cut down was performed to remove the catheter using a gooseneck snare.A venogram was completed to ensure no residual material within the av graft and/or venous system although a significant defect was noted in the av graft that was repaired with covera covered stent graft.

• Brand Name: MICRO-INTRODUCER KIT
• Common Device Name: MICRO-INTRODUCER KIT
• Manufacturer (Section D): GALT MEDICAL CORP.; 2220 merritt dr; suite 100; garland TX 75041
• Manufacturer (Section G): GALT MEDICAL CORP.; 2220 merritt dr; garland TX 75041
• Manufacturer Contact: david derrick ; 2220 merritt dr; suite 100; garland, TX 75041 ; 2147781306
• MDR Report Key: 21769518
• Report Number: 0001649395-2025-00002
• Device Sequence Number: 18252362
• Product Code: OFL
• UDI-Device Identifier: 00841268105614
• UDI-Public: 00841268105614
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2025

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
• Operator of Device: Health Professional
• Device Model Number: KIT-011-62
• Device Lot Number: G25003078
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2024
• 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 Age: 68 YR
• Patient Sex: Male