MAUDE Adverse Event Report: COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-FEM

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Perforation of Vessels (2135); Blood Loss (2597); No Information (3190)

Event Date 12/08/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog is unknown but referred to as cook gunther tulip filter.Implant: (b)(6) 2011.(b)(4).Investigation is still in progress.

Event Description

Description of event according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2011." patient outcome: it is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

(b)(4).Corrected pma/510(k) # from k090140 to k043509.Corrected from malfunction to serious injury.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information was received on 024/18/2017 as follows: the plaintiff allegedly received device implant on (b)(6) 2011 for prevention of blood clot injury after myocardial infarction and massive bilateral pe.The plaintiff alleges device migration, device tilt, vena cava perforation, bleeding, migration of ivc filter and erosion through the cava, and 4 perforated tines after implant of device.

Manufacturer Narrative

Additional information provided determined that this device was manufactured by cook inc.With the submission of this follow up report, william cook europe informs that this complaint has been transferred from william cook europe to cook inc.

Event Description

Additional information provided determined that this device was manufactured by cook inc.With the submission of this follow up report, william cook europe informs that this complaint has been transferred from william cook europe to cook inc.

• Brand Name: GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: thomas hessner kirk ; 400 daniels way; bloomington, IN 47404 ; 8004574500
• MDR Report Key: 6529073
• MDR Text Key: 73906324
• Report Number: 3002808486-2017-01034
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K043509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-FEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/15/2017
• Device Age: 42 MO
• Initial Date Manufacturer Received: 04/15/2017
• Initial Date FDA Received: 04/28/2017
• Supplement Dates Manufacturer Received: Not provided; 04/18/2017
• Supplement Dates FDA Received: 05/08/2017; 08/17/2017
• Date Device Manufactured: 06/22/2010
• 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: 32 YR
• Patient Weight: 111