BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ GENESIS OPTA PRO

    MDR report key: 3113494 · Received May 15, 2013

    Report

    Report Number
    9616099-2013-00299
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Report Date
    March 13, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K012590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE EVENT DATE IS UNKNOWN. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE ACCOUNT, DURING USE OF A LONG PALMAZ GENESIS STENT MOUNTED ON AN OPTAPRO PTA BALLOON CATHETER, THE OPERATOR ENCOUNTERED A PROBLEM; HOWEVER, DETAILS WERE NOT REPORTED. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. A STENT OF A LONG GEN / PRO 39 X 10 BIL 135 WAS RECEIVED HANGING FROM AN UNKNOWN DEVICE ALONG WITH A NON-CORDIS SHEATH INTRODUCER AND ANOTHER NON-CORDIS DEVICE. THE STRUTS WERE UPLIFTED IN THE PROXIMAL AND DISTAL ENDS OF THE STENT. 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 STENT DELIVERY SYSTEM-DAMAGED COULD NOT BE CONFIRMED SINCE THE SHAFT OF THE CATHETER WAS NOT RETURNED FOR ANALYSIS. THE DISTAL AND PROXIMAL STRUTS WERE CONFIRMED TO BE UPLIFTED DURING ANALYSIS OF THE RETURNED STENT; HOWEVER, THE EXACT CAUSE OF THE DAMAGES TO THE STENT COULD NOT BE DETERMINED. WITH THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT THE CUSTOMER IS REPORTING THAT THE LONG GEN STENT MOUNTED ON AN OPTA PRO 39 X 10 BIL 135 HAD A PROBLEM. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS NOT RECEIVED FOR INSPECTION, AN UNKNOWN ADMIRAL WITH A SHEATH AND SNARE WERE RECEIVED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION AND TO LOCATE THE COMPLAINT PRODUCT WERE NOT SUCCESSFUL. ADDENDUM: PRELIMINARY INSPECTION OF THE RETURNED PRODUCT INDICATED THAT A STENT OF A LONG GEN / PRO 39 X 10 BIL 135 WAS RECEIVED HANGING FROM AN UNKNOWN DEVICE ALONG WITH A NON-CORDIS SHEATH INTRODUCER AND ANOTHER NON-CORDIS DEVICE. THE STRUTS WERE UP LIFTED IN THE PROXIMAL AND DISTAL END OF THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214195 PALMAZ GENESIS OPTA PRO ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS DE MEXICO NA 15585436

    Patients

    Seq Age Sex Outcome Treatment
    1