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

Catalog Number C-CAE-14.0-70-FIC

Device Problems Detachment Of Device Component (1104); Sticking (1597)

Patient Problem Tissue Damage (2104)

Event Date 10/19/2015

Event Type  No Answer Provided  

Manufacturer Narrative

(b)(4).Unknown as information was not provided.Unknown as information was not provided.Catalog # c-cae-14.0-70-fic.Product is not received yet.Investigation is still in progress.

Event Description

Description of event according to complainant: while inserting into the throat of the patient a small coil of blue plastic came off the bougie and stuck in the patient's throat.It looked like it had sheared off.It does not obviously appear on the bougie as missing.29oct2015: additional information the rep has gathered so far: i found the nurse and she confirmed it was a single lumen used so that should not be the cause.She did say the section left in the patient铠throat was like a spiral piece of blue plastic.Patient outcome: small coil of blue plastic came off and stuck in the patients throat.The patient required an additional procedure due to soft tissue damage which was a result of the occurrence.

Manufacturer Narrative

(b)(4) catalog # c-cae-14.0-70-fic.Summary of investigation findings: investigation of returned, unused frova catheter confirmed a small part of the material had sheared off approx.5cm from distal tip.Since reported it was discovered when the device was removed from packaging in preparation to use.The appropriate personnel have been notified.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: while inserting into the throat of the patient a small coil of blue plastic came off the bougie and stuck in the patient's throat.It looked like it had sheared off.It does not obviously appear on the bougie as missing.Updated description of event received from customer: the senior anaesthetist involved in the case made it clear that the c-cae-14.0-70-fic was never used on a patient.The senior anaesthetist involved in the case explained that the c-cae-14.0-70-fic was removed from the packaging in preparation to use when the imperfection was noted.The device was bagged and a second device opened for use.As the device was not used on a patient there was never a piece of 'blue plastic' left in the patients airway to remove and the patient was never put at risk of injury.Updated patient outcome: n/a as there is no patient contact.

• 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: 5216385
• MDR Text Key: 30996425
• Report Number: 3002808486-2015-00157
• Device Sequence Number: 1
• Product Code: LRC
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-CAE-14.0-70-FIC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2015
• 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 Age: 46 YR