MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-1-FEM-CELECT-PT

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Perforation of Vessels (2135); Injury (2348); Blood Loss (2597); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Manufacturer reference # (b)(4). Exemption number e2016032. (b)(4). Corrected data based on new information received: adverse event to product malfunction; 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 06/02/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2014 due to deep vein thrombosis and pulmonary embolism. Plaintiff is alleging back and leg pain, and bleeding.

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 ¿back and leg pain, bleeding". Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Unknown if the reported back and leg pain, bleeding 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.

Manufacturer Narrative

(b)(4). Lot #: unknown. Catalog #: unknown but refered 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. Mfr 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 celect filter on (b)(6) 2014 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). Catalog #: unknown but refered 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. Unknown as lot # is unknown. It has not been possible to investigate this event based on the limited information, and we are closing the report until further information is received. If additional information is received, the report will be re-opened for further investigation.

Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2014. " 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). Catalog#: unknown but refered to as a cook celect filter. Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629. (b)(4). Information regarding the event has not been provided. It has not been possible to investigate this event based on the limited information, and we are closing the report until further information is received. If additional information is received, the report will be re-opened for further investigation.

Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2014. " patient outcome; it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.

• Brand Name: COOK CELECT® PLATINUM 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 (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov 4632, IN 47404 ; 8004574500
• MDR Report Key: 5801655
• MDR Text Key: 192889402
• Report Number: 3002808486-2016-00735
• 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,Followup,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/10/2017
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E3192043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 07/12/2016
• Event Location: No Information
• Date Manufacturer Received: 05/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/18/2016 Patient Sequence Number: 1