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	Malfunction
Event or Problem Description
Letters all gone, started to insert it not knowing where the 2 1/2 was.They dropped the original so they opened a new one and i could see it until it was in too deep.

• 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: 25668177
• Report Number: 1649395-2026-00004
• Device Sequence Number: 5701657
• 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: G25350165
• Was Device Available for Evaluation?: No
• 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): No
• 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