MAUDE Adverse Event Report: Galt Medical Corp. Enhance Transcarotid/Peripheral Access Kit

Lot Number	G26016033
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction

• Brand Name: Enhance Transcarotid/Peripheral Access Kit
• Common Device Name: Enhance Transcarotid/Peripheral Access Kit
• 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 ; +1(214)778-1306
• MDR Report Key: 50828648
• Report Number: 1649395-2026-00013
• Device Sequence Number: 15614440
• Product Code: OFL
• UDI-Device Identifier: 00841268107250
• UDI-Public: 00841268107250
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: Exampt
• 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): 09/18/2026

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: G26016033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2026
• 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