BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ BLUE .018 (T_HEPATIC) PERIPHERAL

    MDR report key: 2172788 · Received July 22, 2011

    Report

    Report Number
    9616099-2011-00491
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT UPON DEPLOYMENT AND POSITIONING IN THE PATIENT THE STENT APPEARED TO BE FRACTURED, WITH PARTS BENT OUTWARD. THE PRODUCT WAS REMOVED AND THE PROCEDURE WAS CONTINUED WITH ANOTHER PRODUCT. THERE WERE NO ANOMALIES NOTED ON THE STENT PRIOR TO USE AND THE PRODUCT PREPPED PROPERLY. THERE WAS NO PATIENT INJURY REPORTED. ANALYSIS OF THE RETURNED PRODUCT DID NOT CONFIRM THE FRACTURE. ONE NON STERILE CATHETER PALMAZ BLUE ON SLALOM 6.0 X 15MM 80CM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THERE WERE BLOOD RESIDUES IN THE BALLOON. THE PROXIMAL STRUTS OF THE STENT WERE UPLIFTED. THE BALLOON WAS NOT INFLATED. NO OTHER ANOMALIES WERE OBSERVED IN THE RETURNED DEVICE. THE STENT DID NOT SHOW A FRACTURE AS MENTIONED IN THE COMPLAINT'S EVENT, ONLY PROXIMAL STRUTS OF THE STENT WERE UPLIFTED. REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. NO DHR FROM SUPPLIER WAS REQUIRED SINCE THE STENT WAS NOT FOUND FRACTURED. THE FAILURE REPORTED BY THE CUSTOMER "STENT FRACTURE" WAS NOT CONFIRMED; HOWEVER EXACT CAUSE OF THE "STENT STRUTS UPLIFTED" COULD BE NOT DETERMINED, NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE FAILURE EXPERIENCED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. REFER TO MANUFACTURING WORK MENTIONED (B)(4). THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN. ANALYSIS OF THE RETURNED PRODUCT DID NOT CONFIRM THE STENT FRACTURE. THE PROXIMAL STRUT UPLIFT WAS LIKELY DUE TO INTERACTION WITH THE VESSEL WHILE IT WAS BEING ADVANCED TOWARDS THE LESION. IN THIS CASE, IT IS POSSIBLE THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER WAS RELATED TO PROCEDURAL FACTORS, VESSEL CHARACTERISTICS AND/OR USER HANDLING.

    Description of Event or Problem · 1

    A PALMAZ BLUE STENT APPEARED TO BE FRACTURED, WITH PARTS BENT OUTWARD UPON DEPLOYMENT AND POSITIONING IN THE PATIENT. THE PHYSICIAN DID NOT EXPAND THE STENT AS THE DAMAGE WAS NOTICED PRE-INFLATION. THE PRODUCT WAS REMOVED AND THE PROCEDURE WAS CONTINUED WITH ANOTHER PRODUCT. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ BLUE .018 (T_HEPATIC) PERIPHERAL ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS DE MEXICO NA R0209327

    Patients

    Seq Age Sex Outcome Treatment
    1