BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ GENESIS OPTA PRO

    MDR report key: 4060396 · Received September 4, 2014

    Report

    Report Number
    9616099-2014-00565
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 7, 2014
    Report Date
    November 25, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THE PRODUCT WAS RETURNED FOR ANALYSIS. REFER TO PRODUCT RETURN DATE (OCT 23, 2014). THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING AN ANGIOGRAPHY, IT WAS REPORTED THAT THERE WAS LEAKAGE OF THE BALLOON ON A 6X39MM PALMAZ GENESIS OPTA PRO. AFTER VERIFICATION, ¿THE STENT ROSE TO THE BALLOON, THE BALLOON WAS LEAKING.¿ THE DEVICE WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF LOT 16087375 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED BALLOON LEAKAGE COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, FACTORS CONTRIBUTING TO THE DIFFICULTY EXPERIENCED BY THE CUSTOMER COULD NOT BE DETERMINED. NEITHER THE DHR NOR THE LIMITED INFORMATION AVAILABLE FOR REVIEW SUGGESTS THAT THE REPORTED BALLOON LEAKAGE COULD BE RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: CONCLUSION UPDATED TO INCLUDE ANALYSIS OF RETURNED DEVICE. DURING AN ANGIOGRAPHY, IT WAS REPORTED THAT THERE WAS LEAKAGE OF THE BALLOON ON A 6X39MM PALMAZ GENESIS OPTA PRO. AFTER VERIFICATION, ¿THE STENT ROSE TO THE BALLOON, THE BALLOON WAS LEAKING.¿ THE DEVICE WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS RETURNED FOR ANALYSIS. ONE NON STERILE CATHETER LONG GEN / PRO 39 X 60 PER 80PRO WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE STENT WAS MOUNTED IN ITS ORIGINAL PLACE BETWEEN THE MARKER BANDS. BALLOON WAS NOT PREVIOUSLY INFLATED. NO OTHER DAMAGES WERE FOUND IN THE DEVICE. INFLATION TEST WAS PERFORMED AND A PINHOLE WAS FOUND IN THE PROXIMAL SECTION OF THE BALLOON. SEM RESULTS SHOWED THAT THE BALLOON EXTERNAL SURFACE EXHIBITED EVIDENCE OF SCRATCHING NEAR THE TEAR EDGE. THE BALLOON INTERNAL SURFACE EXHIBITED NO EVIDENCE OF DAMAGED. THIS BALLOON BURST FAILURE EXHIBITED NO OTHER SURFACE ANOMALIES THAT COULD HAVE CAUSED THE FAILURE. THE PROXIMAL MARKER BAND EXHIBITED NO ANOMALIES. REVIEW OF LOT 16087375 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED BALLOON LEAKAGE WAS CONFIRMED THROUGH ANALYSIS OF THE RETURNED DEVICE. THE EXACT CAUSE COULD NOT BE DETERMINED; HOWEVER, EVIDENCE OF SCRATCHING ON THE EXTERNAL SURFACE OF THE BALLOON NEAR THE POINT OF LEAKAGE WAS NOTED. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, FACTORS CONTRIBUTING TO THE DIFFICULTY EXPERIENCED BY THE CUSTOMER COULD NOT BE DETERMINED. NEITHER THE DHR NOR THE ANALYSIS SUGGESTS THAT THE REPORTED BALLOON LEAKAGE COULD BE RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE GENDER OF THE PATIENT IS UNKNOWN. THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT HAS NOT YET BEEN RECEIVED. REVIEW OF LOT 16087375 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING AN ANGIOGRAPHY, IT WAS REPORTED THAT THERE WAS LEAKAGE OF THE BALLOON ON A 6X39MM PALMAZ GENESIS OPTA PRO. AFTER VERIFICATION, ¿THE STENT ROSE TO THE BALLOON, THE BALLOON WAS LEAKING.¿ THE DEVICE WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541814 PALMAZ GENESIS OPTA PRO ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS DE MEXICO NA 16087375

    Patients

    Seq Age Sex Outcome Treatment
    1