MAUDE Adverse Event Report: COOK MEDICAL 001 GUNTHER TULIP VENA CAVA FILTER FEMORAL APPROACH

Model Number IGTCFS-65-1-FEM-TULIP

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 01/27/2014

Event Type  Injury  

Event Description

While using the coaxial introducer sheath system, the physician noticed a crack in the hub, during insertion into the patient.Reason for use: angio suite cardiac intervention.Event abated after use stopped or dose reduced: yes.This product also has this listed on the wrapper: (b)(4).

• Brand Name: GUNTHER TULIP VENA CAVA FILTER FEMORAL APPROACH
• Type of Device: VENA CAVA FILTER FEMORAL
• Manufacturer (Section D): COOK MEDICAL 001; bloomington IN 47402
• MDR Report Key: 3619214
• MDR Text Key: 21730505
• Report Number: MW5034230
• Device Sequence Number: 1
• Product Code: DTK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IGTCFS-65-1-FEM-TULIP
• Device Lot Number: E3104715
• Other Device ID Number: G52917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR