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

Catalog Number	C-CAE-14.0-70-FIC
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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).Manufacturers ref# (b)(4).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).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: it was reported that a cook frova catheter was used to assist with placing a medtronic shiley bronchocath 39l double lumen ett.On bronchoscopy after intubation a plastic foreign bodies was found in the main bronchus.The foreign body was plastic coating off the frova catheter which had sheared off when placed via the dlett.The problem resolved with a fresh catheter and dlett ¿on the bench¿.The frova catheter appears to have an outercoating which easily shaves off on any edge.
Additional Manufacturer Narrative
Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on event description only.No product was returned to assist the investigation, but based on the event description the frova device was used for placing a medtronic shiley bronchocath 39l double lumen ett.However, the frova introducer is designed for placement of a single lumen tube only - not a double lumen tube as reported.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
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 7069916
• Report Number: 3002808486-2017-02306
• Device Sequence Number: 799754
• Product Code: DYB
• UDI-Device Identifier: 00827002483033
• UDI-Public: (01)00827002483033(17)200420(10)E3576046
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2017

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: 11/08/2017
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 12/29/2017
• Patient Sequence Number: 1