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 Material Frayed (1262)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This complaint is logged to capture the additional incidents referred to in the customer report to ansm "this incident happened several times".Name and address for importer site: (b)(4).Similar to device under 510(k) e597079.Investgation is still in progress.

Event Description

Description of event according to initial reporter."difficult intubation required the use of type cook eschmann tube, without difficulty during use.A fibroscopic check immediately after the intubation helped to display an endobronchial foreign matter, which according to the department reporter, would be ¿peeling¿ of the tube.Please note that the probe used was a carlens shiley 39f probe, from covidien.This incident happened several times".Patient outcome: "clinical consequences reported are moderate.Increase of intubation period".

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).Manufacturer ref#: (b)(4).Mfr site: name and address for importer site: (b)(4).Ec method code: 4109 - historical data analysis 4114 - device not returned.Summary of investigational findings: no product was returned to assist the investigation, but it is reported that the peeling was noticed during placement of a double lumen tube and the frova introducer is designed for placement of a single lumen tube only.However, it is noted that the area representative is focusing on the fact that "the problems were always with dlt".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.

• 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: 7649491
• MDR Text Key: 112706495
• Report Number: 3002808486-2018-00789
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• 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: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-CAE-14.0-70-FIC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/26/2018
• Date Manufacturer Received: 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention