MAUDE Adverse Event Report: GALT MEDICAL CORP. GALT FLUENT MICRO-INTRODUCER KIT; PERCUTANEOUS SHEATH INTRODUCER KIT

Model Number	KIT-039-19
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Fluent stiffen micro introducer kit made from two purchased lots of transitionless coaxial dilator assembly.This product distributed to three different customers including the customer who filed original complaints.Galt did not receive any complaints regarding subject device kit-039-19 nor against subcomponents transitionless coaxial dilator assembly int-038-02 from other customers who received the subject lot.The complaint applied to subject device kit-039-09 lot number g21337115 only.Device history record reviewed, for main product and subcomponents and evaluation of the review shows that the subject device associated with the incident in this report does not associate to any non-conformances or process deviations.Documentation and device history review shows both lots of purchased subcomponents transitionless coaxial dilator assembly int-038-02 are inspected and certificate of compliance attached to both lots and pass quality inspections.No samples available for evaluation at this time.End user communicated for additional information about any health consequences regarding this incident and about the broken piece if it has been retrieved from the patient body or not.Also, inquiry sent to end user if there any side effects experienced by the patient.No response or any additional information available at this moment.A follow up report will be send to fda once complaint sample returned to manufacturer for evaluation or any other when any information will be available.
Event or Problem Description
Manufacturer received volunteer medwatch report on 2/22/2023 via email from fda regarding broken piece of micro puncture inside patient body reported by end user on 2/8/2023.Event problem or description of the event stating (the patient had coronary intervention with procedural sedation for chronic total occlusion of right coronary artery with bilateral femoral artery access.On right femoral artery (rfa) access with micro puncture, galt micro puncture sheath broke off at hub inside rfa).

• Brand Name: GALT FLUENT MICRO-INTRODUCER KIT
• Common Device Name: PERCUTANEOUS SHEATH INTRODUCER KIT
• Manufacturer (Section D): GALT MEDICAL CORP.; 2220 merritt dr #100; garland TX 75041
• Manufacturer (Section G): GALT MEDICAL CORP; 2220 merritt dr #100; garland TX 75041
• Manufacturer Contact: diyar medhat ; 2220 merritt dr #100; garland, TX 75041 ; 9722715177
• MDR Report Key: 16438633
• Report Number: 1649395-2023-00003
• Device Sequence Number: 7447589
• Product Code: OFL
• UDI-Device Identifier: 10841268106106
• UDI-Public: 10841268106106
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 04/05/2026
• Device Model Number: KIT-039-19
• Device Lot Number: G21337115
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown