MAUDE Adverse Event Report: GALT MEDICAL CORP. GALT MICRO-INTRODUCER KIT; INTRODUCER, CATHETER

Model Number 4F

Device Problem Break (1069)

Patient Problem Thrombosis (2100)

Event Date 08/05/2019

Event Type  malfunction  

Event Description

Patient presented for thrombosis of arteriovenous graft.Micropuncture wire broke but was retrieved in its entirety.

• Brand Name: GALT MICRO-INTRODUCER KIT
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): GALT MEDICAL CORP.
• MDR Report Key: 8894578
• MDR Text Key: 154457719
• Report Number: MW5089045
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Model Number: 4F
• Device Lot Number: GI19067254
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 114