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 Date 06/07/2018

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: she used the frova with a covidien dlt and when she explored the lungs and the airway she detected a small part of the frova.She could take the part of the frova with a clamp.Patient outcome: a section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of (b)(6) medical (importer).Manufacturer ref# (b)(4).Name and address for importer site: (b)(6).Ec method code: 4109 - historical data analysis.4112 - analysis of data provided by user/third party.Summary of investigational findings: an investigation of the returned frova introducer revealed a small part flaking off approx.3cm from the distal tip.However, it is noted that it was used to place a double lumen tube and the frova introducer is designed for placement of a single lumen tube only.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

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

• 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: 7680840
• MDR Text Key: 113740244
• Report Number: 3002808486-2018-00808
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• PMA/PMN Number: E597079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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: 07/12/2018
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2018
• Distributor Facility Aware Date: 06/25/2018
• 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