MAUDE Adverse Event Report: COOK MEDICAL LLC TULIP VENA CAVA JUGULAR CELECT FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number IGTFS-65-1-JUG-CELECT-PT

Device Problems Material Deformation (2976); Activation Problem (4042)

Patient Problem Insufficient Information (4580)

Event Date 02/04/2022

Event Type  malfunction  

Event Description

Ivc filter inserted into patient and would not deploy and it was found that the tines were braided.Jugular ivc filter.Fda safety report id # (b)(4).

• Brand Name: TULIP VENA CAVA JUGULAR CELECT FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK MEDICAL LLC
• MDR Report Key: 13602345
• MDR Text Key: 286428274
• Report Number: MW5107720
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IGTFS-65-1-JUG-CELECT-PT
• Device Lot Number: E4201903
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2022
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 180 KG
• Patient Ethnicity: Hispanic