BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIATOR PLUS PTA DILATATION CATHETER

    MDR report key: 2220735 · Received August 23, 2011

    Report

    Report Number
    9616099-2011-00657
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K071189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND THE PRODUCT ANALYSIS WAS COMPLETED. CONCOMITANT DEVICES INCLUDE 6F SHEATHLESS PV (ASAHI INTECC), 6F BRITETIP GC (JR4), AND AVIATOR PLUS (6X20MM) BALLOON CATHETER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. ONE NON STERILE CATHETER AVIATOR PLUS 7.0MM X 20MM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE BALLOON WAS INFLATED AND DEFLATED. NO OTHER ANOMALIES WERE NOTED IN THE RETURNED DEVICE. PROXIMAL SEAL WAS MEASURED WITH GC 7F ACCORDING TO (B)(4) AND NO DIFFICULTY WAS NOTED WITH THE REMOVED THE BALLOON. THE BALLOON WAS INFLATED AND DEFLATED AND NO DAMAGES WERE FOUND. 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 BALLOON DAMAGED IN PATIENT AND WITHDRAWAL DIFFICULTY BY THE CUSTOMER WAS NOT CONFIRMED; HOWEVER, CONTROL IS IN PLACE TO PREVENT DEFECTIVE FROM BALLOON DAMAGED AND WITHDRAWAL DIFFICULTY. 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 TIPS FROM LEAVING THE FACILITY (B)(4), NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND WAS UPDATED. PLEASE NOTE, THE PRODUCT ANALYSIS HAS BEEN CORRECTED. AFTER DILATING A LESION WITH AN 85% STENOSIS IN THE LEFT RADIAL VEIN IT WAS NOTED THAT THE BALLOON WAS DEFORMED FLATTENED AND COULD NOT BE WITHDRAWN INTO THE GUIDING CATHETER (GC). THE DEVICE WAS REMOVED FROM THE PATIENT TOGETHER WITH THE GC AS ONE UNIT WITHOUT PATIENT INJURY. ANALYSIS OF THE RETURNED PRODUCT DID NOT CONFIRM THE EVENT. ONE NON STERILE CATHETER AVIATOR PLUS 7.0 MM X 20 MM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE BALLOON WAS INFLATED AND DEFLATED. NO OTHER ANOMALIES WERE NOTED IN THE RETURNED DEVICE. PROXIMAL SEAL WAS MEASURED WITH GC 6F ACCORDING TO (B)(4) AND WITHOUT ANY DIFFICULTY WAS REMOVED OF THE GC. THE BALLOON WAS INFLATED AND DEFLATED AND NO DAMAGES WERE FOUND. 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 BALLOON DAMAGED IN PATIENT AND WITHDRAWAL DIFFICULTY BY THE COSTUMER WAS NOT CONFIRMED; HOWEVER, CONTROL IS IN PLACE TO PREVENT DEFECTIVE FROM BALLOON DAMAGED AND WITHDRAWAL DIFFICULTY. 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 TIPS FROM LEAVING THE FACILITY, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. WITH THE INFORMATION AVAILABLE AND WITHOUT FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE. THERE WAS NO DAMAGE NOTED WITH THE PACKAGING PRIOR TO USE. NO FURTHER INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 1

    THE TARGET LESION WAS LEFT RADIAL VEIN. NO CALCIFICATION OR VESSEL TORTUOSITY, THE RATE OF STENOSIS WAS 85%. APPROACH WAS MADE FROM THE RIGHT FEMORAL VEIN WITH 6F SHEATHLESS PV (ASAHI INTECC) AND 6F BRITETIP GC (JR4) AS COAXIAL SYSTEM. THE DISTAL LESION WAS DILATED WITH AVIATOR PLUS (6X20MM) AND THE PROXIMAL LESION WAS DILATED WITH ANOTHER AVIATOR PLUS (COMPLAINT PRODUCT, 7X20MM). ALTHOUGH WITHDRAWAL OF DEVICE WAS CONDUCTED, IT WAS NOTICED THAT THE BALLOON WAS DEFORMED FLATTENED AND COULD NOT BE WITHDRAWN INTO THE GC. THE DEVICE WAS REMOVED FROM THE PATIENT TOGETHER WITH THE GC AS ONE UNIT WITHOUT PATIENT INJURY. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION. THERE WILL BE PRODUCT RETURN.

    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 R0808173

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR