MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-UNI-CELECT-PERM

Device Problems Break (1069); Detachment Of Device Component (1104); Component Missing (2306)

Patient Problems Abdominal Pain (1685); Foreign Body In Patient (2687)

Event Date 05/29/2014

Event Type  malfunction  

Event Description

Description of event according to complainant: filter placed at (b)(6) hospital on (b)(6) 2011.Ct was done in 2012 which showed 2 legs broken.The pt has not had any trauma or surgery since placement.The pt recently had abdominal pain when a physician at (b)(6) did ct scan and showed leg detached.The filter was retrieved, but it is believed one leg is still in head of pancreas.The other leg was not located.It was questionable when read last ct whether the other leg was located at head of vertebral level.However, it did not look that way.Rather, it was calcium (really thick) and was not convinced it was other leg.Celect filter was retrieved with sheath and forceps.Detached leg located was not retrieved and remained in pt.

Manufacturer Narrative

(b)(4).Investigation is in progress.

• Brand Name: COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; bjaeverskov ; DA
• Manufacturer Contact: marianne hoey, supervisor ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 0123141
• MDR Report Key: 3967368
• MDR Text Key: 4631757
• Report Number: 3002808486-2014-00021
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-UNI-CELECT-PERM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR