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

Lot Number	G25350165
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Type of Reportable Event	Serious Injury
Event or Problem Description
The 4fr micro puncture sheath was inserted per protocol.The rest of the procedure proceeded like normal until the flow controller was disconnected and the filter was assessed.There was a small strip of black material noted in the filter.Upon further assessment, it was noted that one of the black markers from the 4fr sheath was missing.After conversing with the doctor, the conclusion was made that the black strip in the filter was probably from the 4fr micro sheath.

• Brand Name: Transcarotid/Peripheral Access Kit
• Common Device Name: Introducer Kit
• Manufacturer (Section D): Galt Medical Corp.; 2220 merritt dr; garland 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: 50181556
• Report Number: 1649395-2026-00009
• Device Sequence Number: 15521463
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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
• Device Lot Number: G25350165
• 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: 08/07/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2026
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1649395-06-24-2026-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown