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

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

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-1-jug-celect-pt.(b)(4).Summary of investigational findings: investigation is based on event description and returned product.The event description does not match the state of the returned product.The findings of the returned product indicates, that the filter was released partly inside the sheath and a wire guide was used to re-catch the filter hook in order to pull the filter back into the sheath.The root cause of the incident cannot be explained.There is found no evidence to suggest that this device was not manufactured acccording to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: during an ivc filter placement procedure, the subclavian artery was accessed and noted to be tortuous.The physician was able to completely unsheath the filter but when pressed the deployment button the filter got caught on the deployment hook.The physician attempted with the filter out of the sheath and a few times with hook inside of sheath but it kept getting caught on the deployment hook.The sheath was placed back over the filter and removed from the patient.And another of the same device was used to complete the procedure with no harm to the patient.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN JUGULAR 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: 5942348
• MDR Text Key: 54399876
• Report Number: 3002808486-2016-01045
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)181027(10)E3380337
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2016
• Initial Date FDA Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2015
• 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