BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ GENESIS OPTA PRO

    MDR report key: 2032180 · Received March 29, 2011

    Report

    Report Number
    9610978-2011-00062
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 4, 2011
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN Number
    K012590
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ADDITIONAL TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE PRODUCT WAS RETURNED FOR ANALYSIS. THEREFORE, THE FOLLOWING SECTIONS WERE UPDATED: (B)(4). THE COMPLAINT CONCLUSION HAS BEEN UPDATED TO REFLECT ANALYSIS OF THE RETURNED DEVICE. AN OPTA PRO BALLOON CATHETER RUPTURED DURING STENT DEPLOYMENT AND THE END OF THE BALLOON COMPLETELY SEPARATED FROM THE CATHETER. THE PHYSICIAN SPENT ABOUT TWO HOURS WITH A SNARE TO RECOVER THE SEPARATED END OF THE BALLOON. ONCE THE PRODUCT WAS REMOVED ANOTHER BALLOON WAS USED TO FULLY DEPLOY THE STENT WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY. 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. A NON STERILE PALMAZ GENESIS ON OPTA PRO 39MMX80MM, 80CM WAS RECEIVED COILED AND INSIDE A BAG. THE BALLOON APPEARS AS IF IT HAD BEEN INFLATED AND DEFLATED; BALLOON PRESENTS A "T" BURST AT 2.2CM FROM THE DISTAL TIP. STENT WAS NOT INCLUDED. NO OTHER ANOMALY WAS OBSERVED IN THE RETURNED DEVICE. BALLOON WAS NOT FOUND SEPARATED FROM THE CATHETER MENTIONED IN THE EVENT, SINCE IT PRESENTS A "T" BURST, THE BALLOON LOOKS SEPARATED, BUT IT WAS NOT. LEAKTEST PER DP 12169733 REV 1 WAS NOT PERFORMED DUE TO BALLOON CONDITIONS. A SCANNING ELECTRON MICROSCOPE WAS PERFORMED TO THE BALLOON AND RESULTS SHOWED THAT THE BALLOON EXHIBITED EVIDENCE OF EXTERNAL ABRASIONS; THE INNER SURFACE SHOWED NO ANOMALIES. THIS BALLOON BURST FAILURE EXHIBITED NO OTHER ANOMALIES THAT COULD HAVE CAUSED THE FAILURE. THE EXACT CAUSE IF THIS FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. MARKER BANDS SHOWED NO ANOMALIES. THE COMPLAINT WAS REVIEWED WITH THE PET TEAM OF THE SDS LINE IN ORDER TO GET THE LINE ASSESSMENT. PET TEAM PROVIDED A MEMO WITH THE LINE ASSESSMENT. IT WAS CONCLUDED THAT THE SDS PG ON OPTA PRO ASSEMBLY LINE INCLUDES THE BALLOON VERIFICATION CONTROL TO DETECT DAMAGE THAT COULD BE CAUSED BY THE CRIMPING PROCESS. THEREFORE THE OPPORTUNITY OF NOT DETECTING A BALLOON DAMAGED IS VERY UNLIKELY. REFER MWIS RO210121 REV 28, RO210122 REV 46, 10547896 REV 17, RO210054 REV 109 AND 11749551 REV 9. 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 BALLOON BURST FAILURE REPORTED BY THE CUSTOMER WAS CONFIRMED; HOWEVER, THE EXACT CAUSE OF THE BALLOON BURST COULD NOT BE CONCLUSIVELY DETERMINED, CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE BALLOONS FROM LEAVING THE FACILITY. NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE FAILURE EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN. THE BALLOON SHOWED EVIDENCE OF ABRASIONS ON THE OUTER SURFACE THAT WOULD IMPLY THAT VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE PRODUCT WAS NOT RETURNED FOR EVALUATION. AN OPTA PRO BALLOON CATHETER RUPTURED DURING STENT DEPLOYMENT AND THE END OF THE BALLOON COMPLETELY SEPARATED FROM THE CATHETER. THE PHYSICIAN SPENT ABOUT TWO HOURS WITH A SNARE TO RECOVER THE SEPARATED END OF THE BALLOON. ONCE THE PRODUCT WAS REMOVED ANOTHER BALLOON WAS USED TO FULLY DEPLOY THE STENT WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY. 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. 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 15257423 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. 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 15257423. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    A PALMAZ GENESIS OPTA PRO BALLOON CATHETER RUPTURED AND COMPLETELY SEPARATED FROM THE CATHETER. THE PHYSICIAN SPENT ABOUT TWO HOURS GOING IN WITH A SNARE TO RECOVER THE SEPARATED END OF THE BALLOON. ONCE THE PRODUCT WAS REMOVED ANOTHER BALLOON WAS SUED TO FULLY DEPLOY THE STENT, WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS OPTA PRO ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS EUROPA, N.V. NA 15257423

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention