MAUDE Adverse Event Report: WILLIAM COOK EUROPE FROVA INTUBATING INTRODUCER; LRC INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number C-CAE-14.0-70-FIC

Device Problem Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device under 510(k) e597079.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: when removing the frova bougie after placing a double lumen et tube, a shaving of the frova came off the frova but was still attached and so was removed with the frova.Details of incident: "14 fr.Cook frova intubating catheter (bougie) was used to intubate using a 39ch double lumen tube.The bougie is composed of blue plastic material and some of this scraped off while it was being removed from the patient's airway.No aspiration of the dislodged fragment occurred but this is a potential risk in this scenario".Use of the thoracic specific bougie recommended for now, however no reason to suspect that this couldn¿t happen with a standard ett.Mtos informed".Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Nature of injury: none occurred but a similar incident occurred last week when a plastic fragment was displaced into the airway and a bronchoscopy was required to retrieve it.No aspiration of the dislodged fragment occurred but this is a potential risk in this scenario.

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: approx.1cm from the sidehole a shaving had come off of the frova as reported, but it is reported that it occurred while placing a double lumen tube and the frova introducer is designed for placement of a single lumen tube only.However, it is noted that "customer accepts that they should not use frova with a double lumen et tube.Ifu, intended use: "the 14.0 french catheter introducer has been designed for placement of a single lumen endotracheal tube whose inner diameter is 6 mm or larger.Note: do not use the frova intubating introducer with double lumen endotracheal or endobronchial tubes." also, under warnings is stated "do not use the frova intubating introducer with double lumen endotracheal or endobronchial tubes." no evidence to suggest that the device was not manufactured according to specifications.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.

Event Description

Additional information provided: "they both had a 39fr portex double lumen endotracheal tube placed and it was the sharp internal bifurcation of the 2 lumens that caused the shaving.Customer accepts that they should not use frova with a double lumen et tube and niaic (northern ireland adverse incident centre) have advised them of the same.".

• Brand Name: FROVA INTUBATING INTRODUCER
• Type of Device: LRC INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 7315679
• MDR Text Key: 101864415
• Report Number: 3002808486-2018-00307
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 00827002483033
• UDI-Public: (01)00827002483033(17)201128(10)E3660336
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-CAE-14.0-70-FIC
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/21/2018
• Device Age: 2 MO
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 04/10/2018
• Supplement Dates FDA Received: 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1