BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI LD LARGE DIAMETER DILATATION CATHETER

    MDR report key: 1833063 · Received September 14, 2010

    Report

    Report Number
    9610978-2010-00176
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 20, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    KNQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR ANALYSIS, BUT THE ANALYSIS HAS NOT YET BEEN COMPLETED. 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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1016427-2010-00101 AND 9610978-2010-00176.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED (B)(4) 2010 INDICATED THAT THE ENDOLEAK SUBSIDED AND THE PATIENT RECOVERED WELL WITHOUT ANY COMPLICATIONS, AND WAS DISCHARGED FROM THE HOSPITAL. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1016427-2010-00101 AND 9610978-2010-00176. COMPLAINT CONCLUSION: AFTER THE ZENITH (COOK) STENT GRAFT WAS IMPLANTED AT THE ABDOMINAL AORTIC ANEURYSM, THE PALMAZ 4010 WAS MOUNTED ON THE MAXI LD PTA BALLOON CATHETER AND DELIVERED. IT WAS OBSERVED BY ANGIOGRAPHY THAT THE POSITION OF THE PROXIMAL BALLOON MARKER WAS INCORRECT. THE DEVICES WERE REMOVED FROM THE PATIENT AND INSPECTED. IT WAS NOTED THAT THE PROXIMAL MARKER WAS LOCATED CLOSE TO THE DISTAL MARKER. THE PHYSICIAN CONTINUED TO ADJUST THE POSITION OF THE MARKER AND MOUNTED THE PALMAZ ON THE MAXI LD BALLOON AGAIN. THE DEVICES WERE DELIVERED AND THE PALMAZ STENT WAS DEPLOYED; HOWEVER, THE STENT WAS PLACED SOMEWHAT DISTAL THAN INITIALLY PLANNED. THE ANEURYSM CONTINUED TO LEAK SLIGHTLY. AFTER THE MAXI LD BALLOON WAS REMOVED FROM THE PATIENT, IT WAS DISCOVERED THAT THE PROXIMAL MARKER WAS UNFIXED AND EASILY MOVED. THE MARKER BANDS HAD NOT BEEN MANIPULATED PRIOR TO INITIAL USE AND IT WAS UNKNOWN IF THE MARKER BAND WAS ALREADY LOOSE PRIOR TO USE. THE ENDOLEAK SUBSIDED AND THE PATIENT RECOVERED WELL WITHOUT ANY COMPLICATIONS, AND WAS DISCHARGED FROM THE HOSPITAL. THE MALPOSITIONING OF THE MARKER BAND WAS CONFIRMED AS A MANUFACTURING DEFECT. HOWEVER, THE PHYSICIAN WAS AWARE THAT THE MARKERBAND WAS IMPROPERLY POSITIONED AND HAD ALREADY REMOVED THE DEVICE FROM THE PATIENT. INSTEAD OF USING A NEW DEVICE, THE DEFECTIVE DEVICE WAS MANIPULATED AND RE-ADVANCED INTO THE PATIENT RESULTING IN INACCURATE DEPLOYMENT OF THE STENT. ONE NON STERILE UNIT MAXI LD 7F 25 MM X4 CM AND 80 OF LENGTH WAS RECEIVED COILED INSIDE A PLASTIC BAG. NO DRY BLOOD RESIDUES WERE OBSERVED IN THE BALLOON. NO DAMAGES WERE OBSERVED IN PRODUCT. MARKER BANDS LOOKS OUT OF POSITION, PROXIMAL MARKER BAND WAS LOCATED OUT OF POSITION AND CLOSE TO THE DISTAL MARKER BAND AT 23 MM OF SEPARATION. THE BALLOON APPEARS AS IF IT HAS BEEN INFLATED AND DEFLATED. AN ATTEMPT TO INFLATE THE BALLOON WAS MADE; NO LEAKAGE AND MARKER BAND MOVEMENT WAS NOTED. A SCANNING ELECTRON MICROSCOPE ANALYSIS (SEM) WAS PERFORMED TO THE RECEIVED UNIT TO DETERMINE THE PRESENCE OF ADHESIVE. RESULTS SHOWS THAT THE MARKER BANDS WERE FOUND TO BE OUT OF POSITION; THE CAUSE APPEARS TO BE A COMPLETE LACK OF ADHESIVE MATERIAL IN ORDER TO KEEP THE MARKER BANDS FIXED TO THE INNER BODY. THE REASON FOR THIS LACK OF ADHESIVE COULD NOT BE CONCLUSIVELY DETERMINED. 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 REPORTED CUSTOMER COMPLAINT WAS CONFIRMED; THIS COMPLAINT HAS BEEN ESCALATED FOR FURTHER INVESTIGATION. AN INVESTIGATION WAS PREVIOUSLY OPENED TO ADDRESS THE CUSTOMER COMPLAINTS FOR MARKER BANDS OUT OF POSITION FOR MAXI LD PTA AND SAVVY PTA PRODUCTS AND ACTIONS TO ADDRESS THIS ISSUE WERE TAKEN BY (B)(4). THE INVOLVED UNIT IN THIS CUSTOMER COMPLAINT WAS MANUFACTURED AFTER THE ACTIONS FROM (B)(4) WERE IMPLEMENTED. THIS COMPLAINT IS DEEMED AS MANUFACTURING RELATED.

    Description of Event or Problem · 1

    AFTER THE ZENITH (COOK) STENT GRAFT WAS IMPLANTED AT THE ABDOMINAL AORTIC ANEURYSM, THE PALMAZ 4010 WAS MOUNTED ON THE MAXI LD 416-2540S AND DELIVERED. IT WAS OBSERVED BY ANGIOGRAPHY THAT THE POSITION OF THE PROXIMAL BALLOON MARKER WAS INCORRECT. THE DEVICES WERE REMOVED FROM THE PATIENT AND INSPECTED OUTSIDE OF THE PATIENT'S BODY. IT WAS NOTED THAT THE PROXIMAL MARKER WAS LOCATED CLOSE TO THE DISTAL MARKER. THE PHYSICIAN CONTINUED TO ADJUST THE POSITION OF THE MARKER AND MOUNTED THE PALMAZ ON THE MAXI LD BALLOON AGAIN. THE DEVICES WERE DELIVERED AND THE PALMAZ STENT WAS PLACED; HOWEVER, THE STENT WAS PLACED SOMEWHAT DISTAL THAN INITIALLY PLANNED. THE ANEURYSM CONTINUED TO LEAK SLIGHTLY. AFTER THE MAXI LD BALLOON WAS REMOVED FROM THE PATIENT, IT WAS DISCOVERED THAT THE PROXIMAL MARKER WAS UNFIXED AND EASILY MOVED. THE MARKER BANDS HAD NOT BEEN MANIPULATED PRIOR TO INITIAL USE AND IT WAS UNKNOWN IF THE MARKER BAND WAS ALREADY LOOSENED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI LD LARGE DIAMETER DILATATION CATHETER PTA CATHETERS (KNQ) KNQ CORDIS EUROPA, N.V. NA 15133354

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R COOK, ZENITH GRAFT