BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ GENESIS AMIIA

    MDR report key: 2180578 · Received July 27, 2011

    Report

    Report Number
    9616099-2011-00545
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 29, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A NON STERILE SDS RX GEN. AMIIA 6.0X18 142CM WAS RECEIVED COILED AND INSIDE A BAG. THE BALLOON APPEARS AS IF IT WAS INFLATED AND DEFLATED. NO STENT WAS INCLUDED WITH THE RETURNED DEVICE. NO OTHER ANOMALY WAS DETECTED SHAFT, MARKER BANDS OR HUB. MICROSCOPIC ANALYSIS WAS PERFORMED IN THE BALLOON SINCE A PINHOLE IS MENTIONED IN THE COMPLAINT PRELIMINARY COMMENTS AND WHEN THE BALLOON WAS INFLATED A LEAK WAS NOTED NEAR THE DISTAL SECTION OF THE BALLOON. THE FOLLOWING DIMENSIONAL ANALYSES WERE PERFORMED TO THE RETURNED DEVICE. PROXIMAL SEAL OD AND TRANSITION SEAL SHOULD PASS THE CSI, IN THIS CASE 5F; DURING INSERTION THE PROXIMAL OD PASSED WITHOUT PROBLEM. STENT CROSSING PROFILE WAS NOT PERFORMED SINCE NO STENT WAS RETURNED FOR EVALUATION. GW LUMEN SIZE, IT IS COMPATIBLE WITH A 0.014" GW; DURING GW INSERTION, THE GW PASSED WITHOUT PROBLEM. INSERTION PROCEDURE FOR CSI AND GW WERE DONE. AN ATTEMPT TO PERFORM CSI AND GW INSERTION WAS DONE, NO RESISTANCE WAS FELT DURING GW INSERTION IN THE PRODUCT'S GW LUMEN AND PRODUCT INSERTION IN THE CSI. CSI 5F AND GW .014" WERE USED TO DO THE PROCEDURE; RESULTS SHOWED THAT THE BALLOON EXTERNAL SURFACE EXHIBITED EVIDENCE OF EXTERNAL ABRASIONS; THE BALLOON INTERNAL SURFACE EXHIBITED NO EVIDENCE OF DAMAGE. THE EXACT CAUSE OF THE LEAKAGE COULD NOT BE CONCLUSIVELY DETERMINED. THE MARKER BANDS EXHIBITED NO ANOMALIES. 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. WITHDRAWAL DIFFICULTY-THROUGH GUIDE/SHEATH REPORTED BY THE COSTUMER WAS NOT CONFIRMED. THE EXACT CAUSE OF THE REPORTED FAILURE AND THE PINHOLE NOTED COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER CONTROLS ARE PLACED IN THE MANUFACTURING AREA IN ORDER TO DETECT PIN HOLE IN THE BALLOON DURING THE 100% INSPECTION IN THE LEAK TEST. NEITHER THE PRODUCT ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THIS KIND OF FAILURE COULD BE RELATED TO THE ASSEMBLY MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. WITHDRAWAL DIFFICULTY-THROUGH GUIDE/SHEATH REPORTED BY THE COSTUMER WAS NOT CONFIRMED. THE EXACT CAUSE OF THE REPORTED FAILURE AND THE PINHOLE NOTED COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL, LESION AND PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE BOTH THE REPORTED AND CONFIRMED EVENTS.

    Description of Event or Problem · 1

    PTRA: THE TARGET LESION WAS RENAL ARTERY. THE PATIENT'S GENDER AND AGE WERE UNKNOWN. CALCIFICATION AND VESSEL TORTUOSITY WERE UNKNOWN, THE RATE OF STENOSIS WAS 90%. FEMORAL APPROACH. PALMAZ GENESIS (PG) WAS DELIVERED THROUGH 6F BRITETIP GUIDING CATHETER AND THE STENT WAS SUCCESSFULLY PLACED IN THE TARGET LESION. THE PG WAS STUCK DURING REMOVAL FROM THE PATIENT BUT IT WAS SAFELY REMOVED TOGETHER WITH UNKNOWN GUIDEWIRE AS ONE UNIT. THE BTGC ALSO BECAME KINKED DURING THE REMOVAL. AS THE LESION WAS NOT FULLY COVERED BY ONLY THE PG STENT, ANOTHER NEW GC AND GW (BOTH DETAILS UNK) WERE USED AND EXPRESS SD STENT (BSJ) WAS PLACED IN THE LESION. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY. THERE WILL BE PRODUCT RETURN. ADDITIONAL INFORMATION RECEIVED (B)(4) 2011: THE PG BALLOON WAS CAUGHT AT THE DISTAL END OF THE GC WHEN ATTEMPTED TO WITHDRAW INTO THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS AMIIA ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS DE MEXICO NA 15209174

    Patients

    Seq Age Sex Outcome Treatment
    1 6F BRITETIP GUIDING CATHETER