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

Catalog Number C-CAE-14.0-70-FIC

Device Problem Scratched Material (3020)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog#: unknown but referred to as a frova intubating introducer.(b)(4).Investigation is still in progress.

Event Description

Description according to article vlachtsis et al.2006: a (b)(6) year-old female was listed for right thoracotomy and right upper lobectomy for bronchial carcinoma.On airway examination she was mallampati grade 3.Following induction of anaesthesia, laryngoscopy revealed a grade 2 cormack and lehane view of the glottis.An initial attempt to pass a 37 fg left-sided bronchocath ((b)(6)) was hindered by prominent dentition and the decision was made to use the bougie (frova intubating introducer) to avoid dental trauma and aid intubation.The bougie was preloaded on the dlt via the bronchial lumen and the ensemble passed through the cords into the trachea without difficulty.Removal of the bougie did not require any more force than would be expected.Clinical assessment of the dlt showed that the bronchial lumen was in fact in the right main bronchus and an attempt was made to reposition the dlt using a fibreoptic bronchoscope.On bronchoscopy via the bronchial lumen two thin blue fragments of plastic were seen within the right main bronchus.It became apparent that these were thin shavings from the bougie.The site of shaving was a ledge within the bronchocath tube.Initial attempts to remove these with suction and then biopsy forceps via the bronchoscope were unsuccessful.The dlt was removed and the patient re-intubated with a single lumen tube and later a second dlt but attempts to remove the fragments by both anaesthetists and surgeons were again unsuccessful.Surgery proceeded and following the right upper lobectomy, the foreign bodies were removed by the surgical team, via the right bronchial stump, using a fibreoptic bronchoscope with biopsy forceps.The chest was closed and the patient woken and extubated at the end of the case.Patient outcome: unknown.

Manufacturer Narrative

(b)(4).Catalog#: unknown but referred to as a frova intubating introducer.(b)(4).Summary of investigational findings: no product returned to assist the investigation, but a photo in the attached article.Very limited information is provided, but the lead odp confirmed an incident with a (b)(4) bougie and a dlt and this led to them changing their supplier to (b)(4) for the cardiac theatre.However, the (b)(4) introducer is designed for placement of a single lumen tube only - not a double lumen tube as reported.Ifu, intended use: "the 14.0 french catheter introducer has been designed for placement of a single lumen endotracheal tube whose inner diameter is 6 mm or larger.Note: do not use the frova intubating introducer with double lumen endotracheal or endobronchial tubes." also, under warnings is stated "do not use the frova intubating introducer with double lumen endotracheal or endobronchial tubes." 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 according to article vlachtsis et al.2006: a (b)(6) female was listed for right thoracotomy and right upper lobectomy for bronchial carcinoma.On airway examination she was mallampati grade 3.Following induction of anaesthesia, laryngoscopy revealed a grade 2 cormack and lehane view of the glottis.An initial attempt to pass a 37 fg left-sided bronchocath ((b)(4)) was hindered by prominent dentition and the decision was made to use the bougie ((b)(4) intubating introducer) to avoid dental trauma and aid intubation.The bougie was preloaded on the dlt via the bronchial lumen and the ensemble passed through the cords into the trachea without difficulty.Removal of the bougie did not require any more force than would be expected.Clinical assessment of the dlt showed that the bronchial lumen was in fact in the right main bronchus and an attempt was made to reposition the dlt using a fibreoptic bronchoscope.On bronchoscopy via the bronchial lumen two thin blue fragments of plastic were seen within the right main bronchus.It became apparent that these were thin shavings from the bougie.The site of shaving was a ledge within the bronchocath tube.Initial attempts to remove these with suction and then biopsy forceps via the bronchoscope were unsuccessful.The dlt was removed and the patient re-intubated with a single lumen tube and later a second dlt but attempts to remove the fragments by both anaesthetists and surgeons were again unsuccessful.Surgery proceeded and following the right upper lobectomy, the foreign bodies were removed by the surgical team, via the right bronchial stump, using a fibreoptic bronchoscope with biopsy forceps.The chest was closed and the patient woken and extubated at the end of the case.Patient outcome: unknown.

• 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: 6046226
• MDR Text Key: 58018789
• Report Number: 3002808486-2016-01278
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: E597079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-CAE-14.0-70-FIC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2016
• 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): Life Threatening
• Patient Age: 57 DA