BEUDAMED
    FDA Adverse Event Summary report: N

    AMBU AURASTRAIGHT

    MDR report key: 3299805 · Received August 19, 2013

    Report

    Report Number
    9610691-2013-00004
    Date Received
    August 19, 2013
    Report Date
    August 15, 2013
    Manufacturer
    AMBU A/S
    Product Code
    CAE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INSTRUCTIONS FOR USE IS PRINTED AT THE BACK OF THE PACKAGING OF EACH DEVICE INDICATING THE BASIC STEPS IN THE PREPARATION AND USE OF A LARYNGEAL MASK. THE PICTOGRAMS SHOW THAT THE CUFF HAS TO BE DEFLATED COMPLETELY BEFORE USE. THE TEXT ALSO STATES THAT PRE-CHECK MUST BE PERFORMED, "PRE-CHECK: VISUAL INSPECTION AND AIR LEAK TEST OF THE DEVICE." THESE INSTRUCTIONS CANNOT BE ADHERED TO WITHOUT REMOVING THE CUFF-PROTECTOR, WHY IT IS CONCLUDED THAT THE REPORTED EVENT IS HIGHLY UNLIKELY TO REOCCUR WHEN THE DEVICE IS USED ACCORDING TO ITS INTENDED USE. IN THE AURASTRAIGHT PRODUCT INFORMATION STATES THE FOLLOWING: "1. WARNINGS/CAUTIONS: ALL AMBUSTRAIGHT MASKS MUST, PRIOR TO USE, BE INVESTIGATED AND INSPECTED FOR ANY POTENTIAL FOREIGN BODY. THE CUFF-PROTECTOR ONLY SERVES AS PROTECTING THE AMBUSTRAIGHT DURING STORAGE AND TRANSPORTATION AND MUST BE REMOVED PRIOR TO USE." AS PART OF THE COMPLAINT INVESTIGATION, THE PRODUCT RISK EVAL HAS BEEN REVIEWED. THE REPORTED PROBLEM IS INCLUDED IN THE RISK ANALYSIS AND THE RISK FOR A HAZARDOUS SITUATION TO OCCUR AS A RESULT OF THE REPORT IS CONCLUDED TO BE ACCEPTABLY LOW. THE COMPLAINT DATA FOR THE LAST TWO YEARS (05/01/2011 - 05/07/2013) HAS BEEN REVIEWED FOR SIMILAR COMPLAINTS. NO COMPLAINTS CONCERNING CUFF-PROTECTOR INSERTED TOGETHER WITH DEVICE HAS BEEN REPORTED. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM CUSTOMER [CASE REPORT SUBMITTED TO (B)(6)]. "(B)(6) GIRL UNDERWENT GENERAL ANESTHESIA FOR MAGNETIC RESONANCE IMAGING OF SUSPECTED NEPHROBLASTOMA. AN APPROPRIATE SIZE LARYNGEAL MASK AIRWAY [(LMA), PEDIATRIC #2 AURASTRAIGHT DISPOSABLE LARYNGEAL MASK, AMBU A/S, (B)(4)] WAS REMOVED FROM ITS ORIGINAL PACKAGE, LUBRICATED AND EASILY SLID INTO POSITION AFTER IV PROPOFOL ADMINISTRATION. THE LMA CUFF WAS INFLATED AS INSTRUCTED. AT THE END OF AN UNEVENTFUL PROCEDURE, THE LMA CUFF WAS DEFLATED AND THE LMA SMOOTHLY REMOVED. DURING THE RECOVERY PERIOD, SHE COMPLAINED OF A STRANGE FEELING IN HER THROAT WHICH WAS RELATED BY THE ANESTHESIOLOGIST AS A COMMON REPORT OF UNPLEASANTNESS AFTER AIRWAY MANIPULATION. THE GIRL WAS DISCHARGED TO THE WARD WHERE SHE REFUSED TO EAT, DROOLED AND POINTED TO HER THROAT. NO OTHER SIGNS OF UPPER AIRWAY PROBLEMS WERE NOTED. ORAL AND PHARYNGEAL EXAMINATION BY A HEAD AND NECK SURGEON DID NOT REVEAL ANY GROSSLY ABNORMAL FINDINGS." HOWEVER, BECAUSE SYMPTOMS PERSISTED, THE FOLLOWING MORNING, THE SURGEON CONDUCTED OROPHARYNGEAL FIBEROPTIC BRONCHOSCOPY UNDER SEDATION AND EXTRACTED A WHITE HALF ROUND AND POINTED PLASTIC STRUCTURE WHICH WAS FOUND TO BE THE LMA CUFF SHIELD (CUFF-PROTECTOR), DESIGNED BY THE MFR TO SUPPORT THE SHAPE OF THE CUFF WHILE IN STORAGE. THE PHARYNGEAL MUCOSA APPEARED SLIGHTLY EDEMATOUS, WITHOUT NOTABLE INJURY. POST-CASE ANALYSIS REVEALED THAT THE ANESTHESIOLOGIST WHO INSERTED THE LMA DID NOT SEPARATE THE SHIELD (CUFF-PROTECTOR) FROM THE CUFF, AS SHOULD HAVE BEEN DONE BUT POSITIONED THEM BOTH, THE CUFF AND THE ATTACHED SHIELD (CUFF-PROTECTOR), AS ONE UNIT, INTO THE AIRWAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400138 AMBU AURASTRAIGHT OROPHARYNGEAL AIRWAY CAE AMBU A/S AURASTRAIGHT 1406587

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention