BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FROVA INTUBATING INTRODUCER

    MDR report key: 5788635 · Received July 13, 2016

    Report

    Report Number
    3002808486-2016-00699
    Event Type
    Malfunction
    Date Received
    July 13, 2016
    Date of Event
    June 14, 2016
    Report Date
    June 17, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    LRC
    PMA / PMN Number
    E597079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT #: UNKNOWN. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. MFR DATE UNKNOWN. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    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

    Description of Event or Problem · 1

    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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443201 FROVA INTUBATING INTRODUCER LRC INSTRUMENT, ENT MANUAL SURGICAL LRC WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention