MAUDE Adverse Event Report: GALT MEDICAL CORP. HYDROPHILIC GALTSTICK; INTRODUCER KIT

Lot Number	G24247049
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Liver Laceration(s) (1955)
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the coaxial set dilator did not enter the bile duct, causing the guidewire to first bend and then break; and that this led to bleeding in the liver parenchyma.

• Brand Name: HYDROPHILIC GALTSTICK
• 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: 23587418
• Report Number: 1649395-2025-00007
• Device Sequence Number: 9259508
• Product Code: OFL
• UDI-Device Identifier: 00841268105768
• UDI-Public: 00841268105768
• 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): 11/18/2025

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: G24247049
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• 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 Sex: Unknown