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 Material Puncture/Hole (1504); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog #: igtcfs-65-2-uni-celect.Similar to device under 510(k) k090140.Summary of investigational findings: investigation is based on event description and returned product.Filter and long dilator returned together with femoral introducer and jugular introducer system inside ripped sheath; ~5cm of the blue sheath is still attached to the handle portion and ~35cm of the distal end of sheath is covering distal end of jugular introducer - in between the two sheath portions ~20cm sheath is missing.These findings do not match the report stating that filter came out of sheath after femoral approach.Femoral introducer slightly bent, but working as intended.Red safety button unlocked.Remains of blood on piston/cup and on the tactile bump.Jugular introducer apparently used, but red safety button is still locked.Remains of blood on grasping hook and protection sheath is damaged at the tip, probably by filter anchoring hooks.Furthermore, 5 cm sheath still attached to handle is penetrated/ripped ~3cm from handle - probably by primary filter legs (also indicating jugular approach).Primary filter legs are symmetric, but one secondary leg is out of shape and two others are not symmetric.Under normal conditions the sheath is strong enough to accomplish the procedure, and based on investigation findings and information provided the exact reason for filter to penetrate the sheath cannot be determined and also not for the missing sheath portion.From the ifu: ¿filter placement: excessive force should not be used to place filter.¿ there is found no evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: the physician access from femoral and the 7fr sheath in the celect filter set was inserted and positioned, the filter which was preloaded in the femoral delivery system was insert into the sheath, while he advancing the filter, it came out from the proximal part of the sheath.He then removed the whole system out from patient and replaced a new ivc filter set.Patient outcome: no adverse effect 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: 5902986
• MDR Text Key: 52955364
• Report Number: 3002808486-2016-00978
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529219
• UDI-Public: (01)10827002529219(17)160730(10)E3129946
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• 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?: Yes
• Date Manufacturer Received: 04/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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