MAUDE Adverse Event Report: WILLIAM COOK EUROPE FROVA INTUBATING INTRODUCER; DYB INTRODUCER, CATHETER

Catalog Number	C-CAE-14.0-70-FIC
Medical Device Problem Codes	Flaked (1246); Material Frayed (1262)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2012
Type of Reportable Event	Malfunction
Additional 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).A1) unknown as information was not provided.A4) unknown as information was not provided.G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113 g5) similar to device under 510(k) e597079.(b)(4).Summary of investigational findings: no product was returned.The frova introducer is designed for placement of a single lumen tube - not a double lumen tube as reported in this case; according to instructions for use "do not use the frova intubating introducer with double lumen endotracheal or endobronchial tubes." no evidence to suggest product was not manufactured 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 or Problem Description
Description of event according to initial reporter: the patient was intubated with the double lumen tube over the fic although this is against ifu's.On examining the airway with the fibreoptic scope to check the tube placement, a flake of the blue catheter material was seen in the patient trachea.I explained to the nurse manager our ifu's were revised several years ago but as we were not selling directly in ireland there is a possibility the change in ifu's may not have been properly communicated additional information received 15may2012: "the patient was intubated with the double lumen tube (endobronchial tube) over the fic although this is against ifu's.Rep explained to the nurse manager our ifu's were revised several years ago." patient outcome: the flake of material was removed using the suction channel of the scope.The patient did not experience any adverse effects due to this occurrence.

• Brand Name: FROVA INTUBATING INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• MDR Report Key: 6452635
• Report Number: 3002808486-2017-00890
• Device Sequence Number: 18987980
• Product Code: DYB
• UDI-Device Identifier: 00827002483033
• UDI-Public: (01)00827002483033(17)150419(10)E2898823
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2012

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
• Operator of Device: Health Professional
• Device Catalogue Number: C-CAE-14.0-70-FIC
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/11/2012
• Device Age: 1 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2012
• Initial Report FDA Received Date: 04/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67