MAUDE Adverse Event Report: COOK MEDICAL GUNTHER TULIP UNISET WITH NAVALIGN DELIVERY; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS651UNITULIP

Device Problems Positioning Failure (1158); Difficult to Remove (1528)

Patient Problem Great Vessel Perforation (2152)

Event Date 10/25/2014

Event Type  Injury  

Event Description

Failure of a vena cava filter that had been placed during initial procedure.That filter failed to deploy.Patient was returned to the or the next day to retrieve the filter.During the second procedure it became evident that the physician was unable to retrieve the filter and that it had perforated the cava.After multiple attempts to remove the filter, the physician placed another filter.

• Brand Name: GUNTHER TULIP UNISET WITH NAVALIGN DELIVERY
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK MEDICAL; 750 daniels way; p.o. box 489; bloomington IN 47402
• MDR Report Key: 4257367
• MDR Text Key: 19591495
• Report Number: 4257367
• Device Sequence Number: 1
• Product Code: DTK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: IGTCFS651UNITULIP
• Device Lot Number: E3218703
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 34 YR
• Patient Weight: 130