BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVIATOR PLUS PTA DILATATION CATHETER

    MDR report key: 2180381 · Received July 27, 2011

    Report

    Report Number
    9616099-2011-00534
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K071189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE WITHDRAWING THE BALLOON AFTER POST DILATION OF A STENT, THE PHYSICIAN NOTICED THAT THE BALLOON HAD SEPARATED. THE DEVICE WAS REMOVED BY EXTENDING THE ARTERIOTOMY IN THE BRACHIAL ARTERY AND REMOVING THE PIECES. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS LEFT TRANS-BRACHIAL AORTIC CATHETERIZATION WITH DIAGNOSTIC AORTOGRAM. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION REGARDING LESION OR PROCEDURAL CHARACTERISTICS FOR THIS EVENT HAS BEEN PROVIDED. ONE NON-STERILE AVIATOR PLUS .014 5.0MM X 20MM BALLOON CATHETER WAS RECEIVED ON 8/17/2011, COILED INSIDE A PLASTIC BAG. BLOOD RESIDUES WERE OBSERVED IN THE CATHETER. AN UNKNOWN SNARE WAS ALSO RECEIVED. THE BALLOON WAS INFLATED. THE BALLOON WAS SEPARATED INTO TWO PARTS; THE SEPARATION WAS 4.0CM FROM THE DISTAL END. THE FIRST SEGMENT WAS THE 4.0CM SEGMENT OF THE INNER BODY AND DISTAL TIP RIPPED OUT FROM THE REST OF THE OUTER BODY AND BALLOON; THE SECOND SEGMENT WAS THE ELONGATED INNER AND OUTER BODIES; THE INNER BODY WAS ALSO SCRATCHED. NO OTHER ANOMALIES WERE OBSERVED IN THE RETURNED DEVICE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE PTA SYSTEM SEPARATED-IN PATIENT REPORTED BY THE COSTUMER WAS CONFIRMED HOWEVER, THE EXACT CAUSE OF THE DISTAL TIP SEPARATED FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGEST THAT THE DIFFICULTIES EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS, CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE OUTER BODY, INNER BODY AND DISTAL TIPS FROM LEAVING THE FACILITY (CONTROL REFERENCE E.G. MANUFACTURING WORK INSTRUCTION (B)(4)), NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. A VOLUNTARY MEDWATCH WAS ALSO RECEIVED FROM THE ACCOUNT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE SALESREP REPORTED THAT THE PHYSICIAN USED A BRACHIAL APPROACH TO PLACE A STENT IN AN UNKNOWN LOCATION, AND USED AN AVIATOR PLUS BALLOON TO POST-DILATE THE STENT. AS THE PHYSICIAN WAS REMOVING THE BALLOON, THE PHYSICIAN NOTICED SOMETHING WAS WRONG AS HE NEARED THE INSERTION SITE. THE BALLOON WAS UP IN THE LEFT ARM AND BROKE APART. THE PHYSICIAN COULD NOT REMOVE THE BALLOON, SO HE EXTENDED THE ARTERIOTOMY IN THE BRACHIAL ARTERY AND REMOVED THE BALLOON AND PIECES. THE PATIENT IS SAID TO BE FINE. THE SALES REP IS CURRENTLY VISITING THE ACCOUNT TO OBTAIN ADDITIONAL INFORMATION, THE PRODUCT ITSELF, AND THE STERILE LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVIATOR PLUS PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA 15249252

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention