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 Bent (1059); Material Perforation (2205); Difficult to Advance (2920)

Patient Problems Sedation (2368); No Known Impact Or Consequence To Patient (2692)

Event Date 08/03/2011

Event Type  No Answer Provided  

Manufacturer Narrative

(b)(4).Catalog # igtcfs-65-2-uni-celect.Similar to device under 510(k) k090140.Summary of investigational findings: the investigation is based on images and the returned product.Images show that femoral approach is used.Four primary legs are attached in the piston while two of the secondary legs are curled and two of the secondary legs look normal.The filter has penetrated the sheath.The penetration of the sheath is located ~15 cm from distal end.The deformity of the filter occurred during penetration of the sheath or in connection with removal of the filter.Under normal conditions the sheath is strong enough to accomplish the procedure.However, it is seen before that the sheath may kink, if exposed to extensive force and the filter may be prone to exceed the sheath wall if the introducer system is advanced through a kinked sheath.There is found no evidence to suggest that the product was not manufactured within specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: the groin was punctured and the introducer and sheath were inserted into the vena cava.The introducer was removed leaving the sheath insitu.The filter deployment device was inserted into the introducer and advanced through the sheath.There was resistance around the pelvic area and the physician was unable to further insert the filter.The physician thought this may be due to the sheath kinking but was unsure.He attempted to withdraw the filter but it would not withdraw either.The physician then attempted to withdraw the sheath with the filter insitu.This also failed to work.Under imaging it was seen that the filter had pierced the introducer sheath and 3 of the 4 non fixated filter arms were outside of the sheath and bent out of shape.The filter was unable to be moved and so an incision was made in the patient's groin and a cut down was performed to manually remove the filter and sheath.A new filter device was opened and then inserted into the vena cava before manual closure of the incision with sutures.Patient outcome: the patient was initially sedated but required general anesthesia prior to cut down being performed.A cut down procedure was performed to manually remove the filter.No adverse effects to the patient were reported due to this occurrence.

• 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: 5887966
• MDR Text Key: 52490466
• Report Number: 3002808486-2016-00917
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529219
• UDI-Public: (01)10827002529219(17)140523(10)E2748884
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-2-UNI-CELECT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2011
• 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): Hospitalization; Required Intervention
• Patient Age: 60 YR