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

Lot Number	G25350164
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Type of Reportable Event	Malfunction
Event or Problem Description
As surgeon was inserting the sheath into the right carotid artery, she noted the black depth markings were coming off.New micropuncture kit opened and new sheath used without issue.Upon completion of procedure, black depth markings were found in the neuroprotection system filter.

• 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 ; 2147781306
• MDR Report Key: 25666224
• Report Number: 1649395-2026-00002
• Device Sequence Number: 5596772
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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: G25350164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown