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 Break (1069); Detachment Of Device Component (1104); Scratched Material (3020)

Patient Problems Aspiration/Inhalation (1725); No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Lot #: unknown.Expiration date: unknown as lot# is unknown.Mfr date unknown.Investigation is still in progress.

Event Description

Description of event according to complainant: small fragment of bougie sheared off and left in airway after use with size 9 single lumen.Notice on routine bronchoscopy immediately after intubation and removed by suction.Additional information received from physician: as part of a video assisted thoracoscopic surgery (vats) for lobectomy, the thoracic surgeon performed a flexible bronchoscopy via a size 9 endotracheal tube (mallinckrodt hi contour, covidien (b)(4)).To everyone¿s surprise it showed a piece of bright blue plastic in the trachea which was successfully removed with suction.The ett had been sited using a frova intubating catheter (william cook (b)(4)) due to a cormack-lehane grade 3 view.On closer inspection of the bougie, an extremely thin slice of its blue coating had been shaved off at the outside edge of the angled tip.The intubation was atraumatic and the removal of the bougie did not require more force than usual.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: no product was returned and no imaging was provided to assist the investigation and consequently it is very difficult to determine an exact reason why the "small fragment of bougie sheared off and was left in airway after use with size 9 single lumen tube".It is not known, if the mallinckrodt ett may have had a sharp edge on the distal portion of the 15mm connector within the ett.The angle of introduction or removal over the frova has then potentially caused a shaving of frova material to occur.The material is radiopaque extruded polyethylene and the material characteristics do not suggest that flaking would occur, but if it was to encounter a rough edge it may be possible.This is the first complaint received reporting that a fragment sheared off from the frova introducer, when used with a single lumen tube.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: small fragment of bougie sheared off and left in airway after use with size 9 single lumen.Notice on routine bronchoscopy immediately after intubation and removed by suction.Additional information received from physician: as part of a video assisted thoracoscopic surgery (vats) for lobectomy, the thoracic surgeon performed a flexible bronchoscopy via a size 9 endotracheal tube (mallinckrodt hi contour, covidien ireland limited).To everyone's surprise it showed a piece of bright blue plastic in the trachea which was successfully removed with suction.The ett had been sited using a frova intubating catheter (william cook europe aps) due to a cormack-lehane grade 3 view.On closer inspection of the bougie, an extremely thin slice of its blue coating had been shaved off at the outside edge of the angled tip.The intubation was atraumatic and the removal of the bougie did not require more force than usual.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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: 5788635
• MDR Text Key: 50186402
• Report Number: 3002808486-2016-00699
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: E597079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/17/2016

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
• 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
• Initial Date Manufacturer Received: 06/17/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/11/2016
• 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): Required Intervention