MAUDE Adverse Event Report: COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-2-UNI-CELECT-PT

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-2-uni-celect-pt.Similar to device under 510(k) k121629.(b)(4).Summary of investigational findings: since no product is returned the evaluation is based on the description solely.It is reported that the filter is faulty.Failure on the filter hook which seems to have straightened up.Also no ifu in the box and the ifu downloaded online were not very clear.It is not possible to determine a root cause for the straightened hook or missing ifu based on the limited information.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: the ivc filter is faulty.Additional information reveived on 27jul2015: "there are a couple of other aspects to the complaint, not just the failure of the hook (it seemed to straighten up) but also no instructions in box and when instructions downloaded from online they were not very clear." patient outcome: unknown as information was not provided.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 5895797
• MDR Text Key: 52727873
• Report Number: 3002808486-2016-00916
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345048
• UDI-Public: (01)10827002345048(17)180225(10)E3307207
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-2-UNI-CELECT-PT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2015
• Date Device Manufactured: 02/25/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other