MAUDE Adverse Event Report: GALT MEDICAL CORP; MICRO-INTRODUCER

Catalog Number KIT-011-62

Device Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/11/2012

Event Type  No Answer Provided  

Event Description

Patient underwent leg arteriogram, transcatheter thrombolysis and lysis check - non-coronary stent one vessel right leg during hospital admission in 2012.Duplex ultrasound of right leg in 2013 noted a small wire likely fully epithelialized within the superficial femoral artery.Decision was made not to retrieve, maintain antiplatelet therapy and monitor.In 2014, patient informed hospital he had concerns regarding the retained wire which prompted an investigation.

• Type of Device: MICRO-INTRODUCER
• Manufacturer (Section D): GALT MEDICAL CORP; 2220 merritt dr.; garland TX 75041
• MDR Report Key: 4168725
• MDR Text Key: 5022888
• Report Number: 4168725
• Device Sequence Number: 2
• Product Code: DRE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/09/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Invalid Data
• Device Catalogue Number: KIT-011-62
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/09/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2014
• Patient Sequence Number: 1
• Treatment: GLIDEWIRE; NO OTHER THERAPIES
• Patient Age: 59 YR
• Patient Weight: 116