MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problems Difficult or Delayed Positioning (1157); Malposition of Device (2616)

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

Event Date 01/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Lot#: unknown as information was not provided.Catalog#: unknown but referred to as a cook celect filter.Expiration date: unknown as lot# is unknown.Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: "had a young male in his (b)(6), trauma patient.First shot of the ivc was clear so they went to place the celect filter, femoral approach.When they hit the button to release the primary legs, they did not open.The filter was tilted in the ivc with the legs closed.The filter was snared and removed.Placed another manufacturers filter to complete the procedure." patient outcome: no adverse effects.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: only a celect filter was returned and investigation revealed two of the primary legs were squeezed, thus resulting in a smaller diagonal distance.Two secondary filter legs were intertwined, but when uncrossed all secondary legs look fine and with no damages.The exact reason why the filter "legs failed to open and tilt" cannot be determined.However, the filter legs may have been somehow obstructed from fully expanding due to e.G.Ivc anatomical conditions, clots or if not placed in ivc.Also, the root cause for the intertwined filter legs cannot be determined, but the filter may have been twisted during the loading of the filter into the sheath or possibly while advancing the filter out of the sheath resulting in the secondary filter legs becoming intertwined.During the manufacturing/qc processes the spring effect of filter is 100 % controlled, as they are all deployed after advancement through a sheath.Under normal conditions, ivc< 30 mm, the radial force of filter will make filter legs attach to ivc.During manufacturing processes the distances between primary filter legs are verified.Also, after advancement through a testing sheath the spring effect of every filter is verified.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

• Brand Name: UNKNOWN
• 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: 6338279
• MDR Text Key: 67658140
• Report Number: 3002808486-2017-00544
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/31/2017
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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