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

Catalog Number C-CAE-14.0-70-FII

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Name and address for importer site: (b)(4).Similar to device under 510(k): k161813.Investigation is still in progress.

Event Description

Description of event according to initial reporter: ¿after intubation of the trachea while performing a bronchoscopy, a small fragment of a plastic material was detected at bronchial level, presumably detached from the interior of the introducer tube (no deterioration was found externally).Since it occurred in a case of lung transplantation and the lung was removed, it had no consequences for the patient, but it could have had a different outcome under other circumstances.Apparently, the same occurrence has been previously observed (details unknown).¿ after intubation of the trachea, when carrying out bronchoscopic inspection, it appears at the bronchial splinter / scrape level of the plastic material, presumably detached from the interior of the introducer rod (externally there was no deterioration); given that it occurred in a case of lung transplantation and that the lung was explanted, it had no consequences for the patient, which would have occurred in other circumstances during the iot they had difficulties to insert the double-lumen tube so proceeded to use a frova first and through the frova, the double-lumen tube.The procedure was performed in a single attempt and without any difficulty.The placement of the tube of double light was checked with the fibroscope, objectifying in the left bronchial light a strange blue body of the same color as the frova they had just used, so he carefully observed it to confirm if any part was missing, however, it seemed totally integrated.When explanting the lung, it was proceeded to extract the material and it was part of the frova.About the previous incidences no more information can be given.The nurse staff of the theatre room told that this problem happened before.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.Since it occurred in a case of lung transplantation and the lung was removed, it had no consequences for the patient.

• Brand Name: FROVA INTUBATING INTRODUCER
• Type of Device: LRC INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov DK-46 32; DA DK-4632
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 7628468
• MDR Text Key: 111978727
• Report Number: 3002808486-2018-00729
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: C-CAE-14.0-70-FII
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/19/2018
• Initial Date Manufacturer Received: 06/19/2018
• Initial Date FDA Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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