MAUDE Adverse Event Report: WILLIAM COOK EUROPE FROVA INTUBATING INTRODUCER; LRC INSTRUMENT, ENT MANUAL SURGICAL

Model Number	G48303
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/12/2018
Type of Reportable Event	Serious Injury
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.Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: "the product was used in a difficult intubation.After intubation they had fiberscopy to the patient, and they found 2 blue pieces of plastic in patient's airways.They were able to remove the other piece".Patient outcome: unknown.
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).Name and address for importer site: (b)(6).Registration no.: (b)(4).Summary of investigational findings: investigation is based on event description and returned device.It was reported that a fiberoscopy after a difficult intubation found 2 blue pieces of plastic in the patient's airways.One of the pieces was removed and no harm to the patient was reported.Despite several attempts to obtain additional information it is unknown if the catheter was used with a double lumen tube and/or if the second piece of blue plastic was removed.The frova catheter and the small piece of catheter material were returned.An investigation of the catheter revealed a flaking of the material distal to the side-hole and a scratch/damage in the catheter opposite to the flaking.Unfortunately, it was not reported if the catheter was used with a single lumen tube and the type of the tube is unknown, too.Therefore, it is unknown if the tube may have had a sharp edge and/or if the angle of introduction or removal over the frova has potentially caused a shaving of frova material to occur.The material is radiopaque extruded polyethylene and the material characteristics do not suggest that flaking would occur, but if it were to encounter a rough edge it may be possible.There is no evidence to suggest that this device was not manufactured according to specifications and nothing indicates that it did not perform as intended.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: FROVA INTUBATING INTRODUCER
• Common Device Name: LRC INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 8132379
• Report Number: 3002808486-2018-01405
• Device Sequence Number: 141335
• Product Code: LRC
• UDI-Device Identifier: 00827002483033
• UDI-Public: (01)00827002483033(17)211002(10)E3780483
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: E597079
• 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): 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2021
• Device Model Number: G48303
• Device Catalogue Number: C-CAE-14.0-70-FIC
• Device Lot Number: E3780483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Distributor Facility Aware Date: 11/12/2018
• Device Age: 1 MO
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention