BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI PTA BALLOON CATHETER

    MDR report key: 1780479 · Received August 3, 2010

    Report

    Report Number
    9610978-2010-00148
    Event Type
    Injury
    Date Received
    August 3, 2010
    Date of Event
    July 5, 2010
    Report Date
    July 6, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING AN INTERVENTIONAL ENDOVASCULAR PROCEDURE FOR STENT PLACEMENT IN THE ABDOMINAL AORTA THE PHYSICIAN MOUNTED A PALMAZ GENESIS XL 50 MM STENT ON A 7 FR. MAXI LD 14 X 6 80 CM BALLOON CATHETER. DURING INFLATION OF THE BALLOON CATHETER, THE BALLOON WAS NOTED TO BE SHAPED LIKE A "DOG'S BONE." THE PHYSICIAN WAS NOT ABLE TO EXPAND THE STENT WITH THE BALLOON CATHETER AND THE BALLOON BURST. THE BALLOON COULD NOT BE RETRIEVED AND THE PATIENT WAS TAKEN TO SURGERY. THE BALLOON CATHETER WAS DISCARDED AND WILL NOT BE RETURNED FOR INSPECTION. THE PALMAZ GENESIS STENT WILL BE RETURNED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AORTA WAS MODERATELY CALCIFIED AND THE CONTRAST USED FOR THE PROCEDURE WAS ACUPACK WITH A 50:50 MIXTURE OF CONTRAST TO SALINE FOR PREPPING. NO FURTHER INFORMATION HAS BEEN RECEIVED IN RESPONSE TO MULTIPLE INVESTIGATIVE ATTEMPTS. (B)(4): THE PRODUCT WAS NOT RETURNED FOR INSPECTION. 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 15068710 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO UNIT WAS REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NON-CONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15068710. THE MAXI LD BALLOON WAS DISCARDED AND IS NOT AVAILABLE FOR ANALYSIS. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE MADE REGARDING ROOT CAUSE OF THE EVENT. HOWEVER, BASED ON THE AVAILABLE INFORMATION IT APPEARS THAT PROCEDURAL FACTORS INCLUDING LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE INABILITY OF THE BALLOON TO EXPAND THE STENT AND BALLOON BURST. THIS ALONG WITH DEVICE INTERACTION MAY ALSO HAVE CONTRIBUTED TO THE INABILITY TO WITHDRAW THE BALLOON REQUIRING SURGICAL INTERVENTION FOR REMOVAL. WITH REVIEW OF THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR REPORT #1016427-2010-00079 AND #9610978-2010-00148.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #1016427-2010-00079 AND #9610978-2010-00148.

    Additional Manufacturer Narrative · 1

    (B)(4): THE PRODUCT WAS NOT RETURNED FOR INSPECTION. 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 15068710 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO UNIT WAS REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NON-CONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15068710. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR REPORT #1016427-2010-00079 AND #9610978-2010-00148.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING AN INTERVENTIONAL ENDOVASCULAR PROCEDURE FOR STENT PLACEMENT IN THE ABDOMINAL AORTA, THE PHYSICIAN MOUNTED A PALMAZ GENESIS XL 50 MM STENT ON A 7 FR. MAXI LD 14 X 6 80 CM BALLOON CATHETER. DURING INFLATION OF THE BALLOON CATHETER, THE BALLOON WAS NOTED TO BE SHAPED LIKE A "DOG'S BONE". THE PHYSICIAN WAS NOT ABLE TO EXPAND THE STENT WITH THE BALLOON CATHETER AND THE BALLOON BURST. THE BALLOON COULD NOT BE RETRIEVED BY THE STENT AND THE PATIENT WAS TAKEN TO SURGERY. THE BALLOON CATHETER WAS DISCARDED AND WILL NOT BE RETURNED FOR INSPECTION. THE PALMAZ GENESIS STENT WILL BE RETURNED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AORTA WAS MODERATELY CALCIFIED AND THE CONTRAST USED FOR THE PROCEDURE WAS ACUPACK WITH A 50:50 MIXTURE OF CONTRAST TO SALINE FOR PREPPING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI PTA BALLOON CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA 15068710

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R PALMAZ GENESIS XL 50 MM STENT