MAUDE Adverse Event Report: GALT MEDICAL CORP GALT STIFFEN MIRCO-INTRODUCER KIT; NONE

Model Number KIT-011-42

Device Problems Detachment Of Device Component (1104); Material Separation (1562); Device Operates Differently Than Expected (2913)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 09/29/2014

Event Type  Injury  

Event Description

Bilateral iliac stenting was being completed in cath lab on an (b)(4) female by vascular surgeon when stiffen micro-introducer/dilator from kit sheared at the hub causing the right superficial femoral artery to retain approx 4 cm piece of introducer.

• Brand Name: GALT STIFFEN MIRCO-INTRODUCER KIT
• Type of Device: NONE
• Manufacturer (Section D): GALT MEDICAL CORP; 2220 merritt dr; garland TX 75041
• MDR Report Key: 4156406
• MDR Text Key: 4917319
• Report Number: 4156406
• Device Sequence Number: 1
• Product Code: DYB
• 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: 10/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2018
• Device Model Number: KIT-011-42
• Device Lot Number: S14097756
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/29/2014
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 66