MAUDE Adverse Event Report: GALT MEDICAL CORP. ENHANCE; ENHANCE TRANSCAROTID PERIPHERAL ACCESS KIT

Lot Number	G24309535
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Tip of wire of transaortic/peripheral access kit broke off in carotid artery requiring exploration to retrieve and suture repair of carotid artery.Entry needle bevel shorter than usual and wire was difficult to move through needle tip.

• Brand Name: ENHANCE
• 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 ; 2147781306
• MDR Report Key: 22099884
• Report Number: 1649395-2025-00005
• Device Sequence Number: 20671617
• 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: EXEMPT
• 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): 05/02/2025

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: G24309535
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2024
• 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: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 65 KG