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 01/16/2018

Event Type  Injury  

Manufacturer Narrative

(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 and was left in the patients airway.This had to be removed with a rigid bronchoscopy.Patient outcome: as above the shaving was removed with a rigid bronchoscopy.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

Additional information received 20mar2018: "they 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 (b)(6) have advised them of the same.".

Manufacturer Narrative

Exemption number e2016032.(b)(4).Summary of investigational findings: no product was returned to assist the investigation, 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.

• 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: 7326382
• MDR Text Key: 101957527
• Report Number: 3002808486-2018-00338
• 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,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?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-CAE-14.0-70-FIC
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/26/2018
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/09/2018
• 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
• Patient Outcome(s): Required Intervention