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

Catalog Number	C-CAE-14.0-70-FIC-SPOPS
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Catalog # c-cae-14.0-70-fic-spops.Awaits product to be returned.Investigation is still in progress.
Event or Problem Description
Description of event according to complainant: the frova has a significant bend in it and the doctor was unable to pass the ett over the frova to intubate the patient.The frova had to be removed and another bougie placed to be able to intubate patient.Patient outcome: no part of the device remained inside the patient the patient did not require any additional procedures due to this occurrence, but an additional device had to be used during the procedure.No adverse effect to the patient.
Additional Manufacturer Narrative
(b)(4).Catalog # c-cae-14.0-70-fic-spops.Awaits product to be returned.Summary of investigational findings: no imaging was provided, but an investigation of the returned frova catheter revealed a minor kink approx.21cm from proximal end.It cannot be determined exactly how or when in time it was kinked, or if this small kink caused enough of a problem to prevent ett migration.Many variables can lead to a failed intubation, but since only very limited information was provided, it is not possible to determine, if the kink contributed to the difficulties encountered when attempting to intubate the patient.It should be noted, that the patient did not require any additional procedures.There is no evidence to suggest the product was not manufactured according to specifications.Cook medical will continue to monitor for similar events.
Event or Problem Description
Description of event according to complainant: the frova has a significant bend in it and the doctor was unable to pass the ett over the frova to intubate the patient.The frova had to be removed and another bougie placed to be able to intubate patient.Patient outcome: no part of the device remained inside the patient.The patient did not require any additional procedures due to this occurrence, but an additional device had to be used during the procedure.No adverse effect to the patient.

• Brand Name: FROVA INTUBATING INTRODUCER
• Common Device Name: LRC INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• MDR Report Key: 5485397
• Report Number: 3002808486-2016-00089
• Device Sequence Number: 18931607
• Product Code: LRC
• UDI-Device Identifier: 00827002535176
• UDI-Public: (01)00827002535176(17)170806(10)E3243400
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: E597079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2016

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-SPOPS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2016
• Supplement Report FDA Received Date: 05/10/2016
• 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: Other