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)
Date of Event	12/15/2017
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: change of intubation catheter on (b)(4).During fibroscopic control, ablation of a foreign body of blue color, corresponding to a piece of (b)(4).Physician use the frova for exchange a double lumen tube 39 g for a smaller one 37.He found some small pieces of the frova, blue color, during fibroscopic control and they removed the pieces.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Exemption number e2016032.(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 exchanging "a double lumen tube 39 g for a smaller one 37".However, the frova introducer is designed for placement of a single lumen tube only - not a double lumen tube as reported.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: 7181523
• Report Number: 3002808486-2018-00101
• Device Sequence Number: 1110183
• Product Code: DYB
• UDI-Device Identifier: 00827002483033
• UDI-Public: (01)00827002483033(17)201027(10)E3647269
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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?: 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: 12/20/2017
• Device Age: 2 MO
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1