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

Catalog Number C-CAE-14.0-70-FIC-SPOPS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog # c-cae-14.0-70-fic-spops.Awaits product to be returned.Investigation is still in progress.

Event 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.

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 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
• Type of Device: LRC INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 5485397
• MDR Text Key: 40487546
• Report Number: 3002808486-2016-00089
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 00827002535176
• UDI-Public: (01)00827002535176(17)170806(10)E3243400
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: E597079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-CAE-14.0-70-FIC-SPOPS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other