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

Catalog Number UNKNOWN

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 11/25/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog number: unknown but referred to as a cook günther tulip filter.Since catalog number is unknown the 510(k) could be either k090140, k112119 or k121057.Investigation is still in progress.

Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2014 (b)(4) and (b)(6) 2014 (b)(4).The filter was placed at the (b)(6) hospital in (b)(6)." patient outcome: unknown.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

(b)(4).Corrected data based on new information received: adverse event to product problem, serious injury to malfunction.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information received on 04/20/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2014 due to a non-occlusive thrombus in left femoral vein resulting from being struck by a motor vehicle.Plaintiff is alleging that the filter was implanted in the wrong vein (i.E, the right iliac vein).Patient alleges successful retrieval on (b)(6) 2014 at which time another filter was implanted.

Manufacturer Narrative

Manufacturer reference # (b)(4).Exemption number e2016032.(b)(4).It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating ¿filter implanted in the wrong vein".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632
• Manufacturer Contact: thomas hessner kirk ; 400 daniels way; bloomington, IN 47404 ; 8004574500
• MDR Report Key: 5553701
• MDR Text Key: 42035767
• Report Number: 3002808486-2016-00163
• 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: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/15/2016
• Date Manufacturer Received: 08/15/2017
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 19 YR
• Patient Weight: 73