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

Catalog Number IGTCFS-65-2-UNI-CELECT

Device Problems Positioning Failure (1158); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-2-uni-celect.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: the device were returned to assist the investigation.Filter had detached and was damaged in a way affecting the distances between filter legs.The cup on femoral introducer was slightly oval-shaped.A crack was noted in the tip of the blue sheath.Incipient kinks were noted 16mm, 22.5cm, and 32.7cm from distal end.A penetration 25cm from distal end was noted.Marks were also noted on sheath at 43cm and 52.5cm from distal end, as if incipient penetration by the primary legs from inside.These findings indicate a jugular approach, but do not agree with descripition of event according to complainant; "filter sheath in the femoral vein".Hence, the exact reason for reported advancement difficulties cannot be determined.Under normal conditions the sheath is strong enough to accomplish the procedure.However, it is possible that the sheath may kink if exposed to force.And if the filter is forcefully advanced through a kinked sheath, the filter legs may exceed the sheath wall.Ifu: "excessive force should not be used to place the filter." cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: "after inserting the filter sheath in the femoral vein to its target site in the ivc and preparing the filter on the table the usual way we do every time we use this filter (everything looked ok at the time), the filter was stuck during its advancement in its sheath, even after making sure that the sheath is not kinked for any reason.After several trials of gentle pushing trying to deliver it out of the sheath to the ivc, it was still stuck in the sheath, so i had to get it out, inspected it, to me if looked fine, so another trial to advance it in the sheath was done, but unfortunately again it was stuck in the middle of the sheath and this time it did not move either in or out, so there was no way out except getting the whole sheath, with the filter inside it, out of the patient and do compression on the femoral vein (heparin was already given).On table, we managed to get the filter out of the sheath, and again it looked ok to everyone that was present in the cath lab (not distorted and well attached to its hooks).Accordingly, we did another femoral vein puncture, introduced the same sheath in and tried for the third time to deliver the filter through it, again the same happened, it was stuck in without any forward or backward movement, so we had to get everything out of the vein again, compress the vein and decided not to use it again.Fortunately for the patient, another filter (other brand) was available in the cath lab, so a third femoral puncture was done for the patient.And the other filter was delivered successfully in the ivc." patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence."the patient did fine and was discharged on the next day and was doing ok on his follow-up visit.".

• Brand Name: COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS
• 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: 5909796
• MDR Text Key: 53278088
• Report Number: 3002808486-2016-00854
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 07/14/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2013
• 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
• Patient Age: 48 YR
• Patient Weight: 70