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

Catalog Number IGTCFS-65-1-UNI-CELECT-PT

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Rpn: igtcfs-65-1-uni-celect-pt.Summary of investigational findings: it is assumed that the "delivery sheath" is the introducer sheath and that the femoral filter introducer was used since it is stated that "the filter was inserted thru the check-flo valve" indicating that the filter wasn't covered by a sheath (the jugular protection sheath) and that the filter was intact when inserted and mis-shapen when pulled out which will happen if inserted and pulled out in the femoral introducer.This then indicates that the mis-shapen filter is caused by the use of the product and not by a production error.The resistance experienced by the user could be due to tortuous anatomy and/or kinking of the device, however, we cannot verify this without a returned device.It is reported that using a new filter introducer with the original introducer sheath was possible, but this does not exclude kinking as a cause since a kinked sheath might be passable when moved a bit to reduce the kink and a new introducer helps further straightening out the sheath.Since no product is returned and no photos are available to assist the investigation, the exact reason for the resistance encountered cannot be determined.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: the delivery sheath was in place.The ivc filter was inserted thru the check-flo valve and into the sheath.About half way up the sheath, the doctor felt resistance and was unable to advance the filter any further.The doctor then removed the filter back out of the hub.Upon inspection, the filter was mis-shapen and the physician was uncertain to why the difficulty occurred.The doctor then opened up a new igtcfs-65-1-uni-celect-pt and utilized the originally opened sheath (from the complaint device) to complete the intended procedure.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 5580449
• MDR Text Key: 43633807
• Report Number: 3002808486-2016-00196
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2016
• 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 Outcome(s): Other