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 No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A (b)(6) patient was scheduled for laser resection of a laryngeal tumor.Induction of anesthesia was uneventful; however, direct laryngoscopy only allowed visualization of the posterior larynx.To facilitate endotracheal intubation, we introduced a frova intubating catheter (c-cae-14.0-70).Subsequently, a laser-resistant endotracheal tube was inserted, and the frova catheter was removed without noting any resistance.The tube was cuffed and connected to the ventilator circuit.An increased resistance was noted during manual ventilation, and routine pulmonary auscultation revealed abnormal stridorous sounds, suggesting airway obstruction.Immediate inspection of the respiratory system revealed a blue mass obstructing the proximal laser-shield tube.The tube was disconnected from the ventilator circuit, and the mass was extracted with a magill forceps.Subsequently, the ventilator was reconnected, stethoscopic auscultation was normal now, and mechanical ventilation was initiated without problems.Using a fiberoptic scope, the endotracheal tube and the tracheobronchial system were inspected to exclude that additional foreign material had been dispersed within the airways.No other foreign bodies were found.The actual surgical procedure and postoperative recovery were uneventful.The blue mass was a convoluted, paper-thin strip of plastic, likely sheared from the frova catheter during introduction/withdrawal through the laser-shield tube, although no resistance was noted during insertion of the tube or withdrawal of the catheter.Interestingly, the stripped plastic had coiled into a convolute with critical dimension to cause relevant airway obstruction.Patient outcome: a section of the device did not remain inside the patient's body.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.

Manufacturer Narrative

(b)(4).Summary of investigational findings: no product was returned and no imaging was provided to assist the investigation and consequently it is difficult to determine an exact reason why "paper-thin strip of plastic, likely sheared from the frova catheter during introduction/withdrawal through the laser-shield tube".Since no device or imaging have been available and no medical records have been made available the exact root cause for what caused the unexpected equipment damage is unknown.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the device did not perform as intended.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to journal article, schober et al: a (b)(6) year-old patient was scheduled for laser resection of a laryngeal tumor.Induction of anesthesia was uneventful;however, direct laryngoscopy only allowed visualization of the posterior larynx.To facilitate endotracheal intubation, we introduced a frova intubating catheter (c-cae-14.0-70).Subsequently, a laser-resistant endotracheal tube was inserted, and the frova catheter was removed without noting any resistance.The tube was cuffed and connected to the ventilator circuit.An increased resistance was noted during manual ventilation, and routine pulmonary auscultation revealed abnormal stridorous sounds, suggesting airway obstruction.Immediate inspection of the respiratory system revealed a blue mass obstructing the proximal laser-shield tube.The tube was disconnected from the ventilator circuit, and the mass was extracted with a magill forceps.Subsequently, the ventilator was reconnected, stethoscopic auscultation was normal now, and mechanical ventilation was initiated without problems.Using a fiberoptic scope, the endotracheal tube and the tracheobronchial system were inspected to exclude that additional foreign material had been dispersed within the airways.No other foreign bodies were found.The actual surgical procedure and postoperative recovery were uneventful.The blue mass was a convoluted, paper-thin strip of plastic, likely sheared from the frova catheter during introduction/withdrawal through the laser-shield tube, although no resistance was noted during insertion of the tube or withdrawal of the catheter.Interestingly, the stripped plastic had coiled into a convolute with critical dimension to cause relevant airway obstruction.Patient outcome: a section of the device did not remain inside the patient¿s body.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.

• 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: 5945507
• MDR Text Key: 54933096
• Report Number: 3002808486-2016-01046
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: E597079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• 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: 08/25/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR