MAUDE Adverse Event Report: WILLIAM COOK EUROPE FROVA INTUBATING INTRODUCER; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/31/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Name and address for importer site: (b)(4).Ec method code: (b)(4) - type of investigation not yet determined.Investigation is still in progress.

Event Description

Description of event according to initial reporter: frova broke during procedure.Part of the broken frova went into patient's lung.Additional information received 03sep2018: frova broke during procedure.Approximately 10cm from frova's distal tip broken and falls into the bronchus.Patient outcome: managed to retrieve the broken part from bronchus, no additional procedures required.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi).400 daniels way.Bloomington, in 47404.Registration no.: 3005580113.Summary of investigational findings: investigation is based on the returned device.The frova catheter was returned with the stylet inside.The catheter tip had separated 10cm from distal end and exactly at the distal end of the stylet.The total catheter length incl the separated tip is 65cm.The breaking point of the tip is severely damaged; probably by tools during retrieval from bronchus.The distance markers are with "cm" and the material appears stiff and brittle; a crack is noted between the 16cm and 17cm markings and also two 15mm flakings are noted, one on each side of the crack.As of 2007 the frova was no longer manufactured in 65cm, but in 70cm and as of 2003 the distance markers were no longer with "cm" (ex 15cm), but only with numbers (ex 15).Based on these findings it is assumed that the device has been autoclaved and reused more than once, despite addressed in the ifu during the years that the device is intended for one-time use.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: FROVA INTUBATING INTRODUCER
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 7884221
• MDR Text Key: 120520290
• Report Number: 3002808486-2018-01100
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: E597079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Distributor Facility Aware Date: 09/03/2018
• Date Manufacturer Received: 10/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention