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

Catalog Number IGTCFS-65-1-FEM-TULIP

Device Problem Insufficient Information (3190)

Patient Problems Cramp(s) (2193); Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog #: unknown but referred to as a cook günther tulip filter.Expiration date: unknown as lot# is unknown.Since catalog # is unknown the 510(k) could be either k090140, k112119 or k121057.Mfr date unknown as lot # is unknown.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) 2013 at (b)(6) medical center." 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).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) 2013 at (b)(6)".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).Name and address for importer site: (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 04/22/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2013 via the right femoral vein due to dvt and pe.Plaintiff is alleging occasional cramps on right side.

Manufacturer Narrative

Manufacturer reference # (b)(4).Exemption number e2016032.William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).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 "occasional cramps on right side".Cook will reopen its investigation if further information is received.20 devices in lot.No relevant notes on wo for neither device (igtcfs-65-1-fem-tulip) lot# e2995015, nor filter tulip lots# e2991506 and e2991537.No other complaints on lot.Product is manufactured and inspected according to 1000361mi (device mi), 1000440qc (device qci), a41935 (tulip mi), and a41936 (tulip qci).Unknown if the reported occasional cramps on right side is directly related to the filter and unable to identify a corresponding failure mode at this point in time.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: GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: thomas hessner kirk ; 400 daniels way; bloomington, IN 47404 ; 8004574500
• MDR Report Key: 5553690
• MDR Text Key: 42035889
• Report Number: 3002808486-2016-00162
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090140
• 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,Followup
• Report Date: 08/09/2017

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-FEM-TULIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/15/2016
• Initial Date Manufacturer Received: 03/14/2016
• Initial Date FDA Received: 04/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 07/20/2017
• Supplement Dates FDA Received: 06/02/2016; 06/13/2017; 08/09/2017
• Date Device Manufactured: 10/18/2012
• 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 Weight: 86