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

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

Device Problem Difficult to Advance (2920)

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

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Name and address for importer site: (b)(4).Similar to device under 510(k) k121629.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: "as operator advanced device into introducer sheath, resistance was encountered.Consequently whole device was removed and new device was opened and advanced to conclude the procedure".Patient outcome: the patient did require an additional procedures due to this occurrence: "introduction of new ivc filter device".According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on event description and returned device.Femoral introducer with loaded filter returned inside the blue sheath - the filter placed approx.10cm from sheath tip.The red locking mechanism was pressed, ie the system was unlocked.Several damages were noted on the sheath; two incipient penetrations approx.26cm from sheath tip.Kink and penetration approx.20cm from sheath tip and an incipient penetration directly opposite.A kink approx.5cm from tip.Unsure, if occurred during procedure or when packed for return.During investigation hardened blood prevented the loaded filter from releasing, why the introducer was cut to remove the filter from the femoral cup.After removal four secondary filter legs were found deform/out of shape, while the primary filter legs were properly shaped and placed.The size of the penetrations indicate them being made by the smaller secondary filter legs, more than the filter hook, thus suggesting that moving the introducer back and forth, when "resistance was encountered" caused the secondary filter legs to penetrate the sheath.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that it did not perform as intended.Cook medical will continue to monitor for similar events.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 7058387
• MDR Text Key: 93574746
• Report Number: 3002808486-2017-02290
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345048
• UDI-Public: (01)10827002345048(17)200620(10)E3598244
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/08/2017
• Device Age: 4 MO
• Date Manufacturer Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2017
• 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