MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-JUG-CELECT-PERM

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

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.

Event Description

This additional information received on 08feb2018 as follows: pt allegedly received an implant on (b)(6) 2009 due to pulmonary embolisms. Pt is alleging filter in place more than 90 days, too risky to attempt retrieval and future perforation and fracture are likely.

Manufacturer Narrative

Exemption number e2016032e lot. (b)(4). Correction: exemption number and importer name and address. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.

Manufacturer Narrative

(b)(4). Blank fields on this form indicate the information is unknown or unavailable. Catalog#: unknown but referred to as a cook celect filter. (b)(4). Since catalog# is unknown the 510(k) could be either k061815 or k073374. (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 ¿celect filter implanted". Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56.

Event Description

Description of event according to short form complaint filed: it is alleged that "patient received a cook celect filter on (b)(6) 2009". It is alleged that patient was injured without further explanation. Hospital and medical records have been requested but not yet provided.

• Brand Name: COOK CELECT JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 7120338
• MDR Text Key: 266709242
• Report Number: 3002808486-2017-02460
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K073374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: IGTCFS-65-JUG-CELECT-PERM
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 11/30/2017
• Event Location: No Information
• Date Manufacturer Received: 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 12/15/2017 Patient Sequence Number: 1