BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ GENESIS OPTA PRO

    MDR report key: 2081656 · Received May 9, 2011

    Report

    Report Number
    9616099-2011-00312
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION, BUT HAS NOT YET BEEN RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. 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. REVIEW OF LOT 15258168 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15258168. SDS-ASSY GENESIS SUBASSEMBLY LOT 15256421 WAS REVIEWED AND (B)(4). IT WAS OBSERVED DURING REVIEW THAT NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. THE STENT CRIMPED PROCESS WAS REVIEWED AND THE STENT CROSSING PROFILE AND STENT RETENTION TESTS WERE ACCEPTED ACCORDING TO SPECIFICATION. THE STENT RETENTION VALUES WERE REVIEWED AND IT WAS FOUND THAT THE RESULTS WERE ACCEPTED ACCORDING TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT ANALYSIS WAS COMPLETED. INFORMATION RECEIVED NOTED THAT THE PALMAZ GENESIS STENT WAS A LITTLE SEPARATED FROM THE BALLOON. THERE WAS A GAP BETWEEN THE STENT AND THE BALLOON. THE PRODUCT WAS NOT USED IN THE PATIENT. THE PRODUCT WAS STORED ACCORDING TO THE LABELING INSTRUCTIONS. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION, OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT HAS BEEN PROVIDED. ONE NON STERILE CATHETER SDS GENESIS 8.0CM X 29MM 135CM OPTA PRO WAS RECEIVED COILED INSIDE A PLASTIC BAG. A STOP COCK WAS INCLUDED IN A PLASTIC BAG. THERE WERE BLOOD RESIDUES IN THE CATHETER. THE BALLOON APPEARS AS IF IT HAD BEEN INFLATED AND DEFLATED, ALSO THE BALLOON PRESENTS THE MARKS OF THE STENT. THE STENT WAS RETURNED LOOSE AND IT WAS FOUND INSIDE THE STOP COCK. AS PART OF THE ANALYSIS, IT COULD BE NOTED THAT THE STENT WAS PLACED CORRECTLY BETWEEN THE 2 MARKER BANDS. NO OTHER ANOMALY WAS OBSERVED IN THE RETURNED DEVICE. 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 LOOSE CRIMP FAILURE WAS CONFIRMED; HOWEVER, THE EXACT CAUSE COULD NOT BE DETERMINED. NEITHER THE DHR REVIEW NOR THE ANALYSIS SUGGESTS THAT THE REPORTED FAILURE REPORTED BY THE CUSTOMER IS RELATED TO THE MANUFACTURING PROCESS. CONTROLS ARE IN PLACED TO DETECT STENT OUT OF POSITION BEFORE LEAVING THE FACILITY. (B)(4). THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN. ALTHOUGH IT WAS NOTED THAT THE DEVICE WAS NOT USED IN THE PATIENT, THE RETURNED DEVICE SHOWED OTHERWISE. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT FILMS OF THE EVENT, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, AS THE STENT WAS RETURNED INSIDE OF THE STOPCOCK, PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT

    Description of Event or Problem · 1

    THE PALMAZ GENESIS STENT WAS A LITTLE SEPARATED FROM THE BALLOON. THERE WAS A GAP BETWEEN THE STENT AND THE BALLOON. THE PRODUCT WAS NOT USED IN THE PATIENT. THE PRODUCT WAS STORED ACCORDING TO THE LABELING INSTRUCTIONS. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS OPTA PRO ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS DE MEXICO NA 15258168

    Patients

    Seq Age Sex Outcome Treatment
    1