BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRE STAR RX PTCA BALLOON CATHETER

    MDR report key: 1861986 · Received October 8, 2010

    Report

    Report Number
    9616099-2010-00779
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 18, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P880003/S90
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A 0.014 HTF WIRE AND 2.5 X 20 SPRINTER LEGEND BALLOON.THE PRODUCT IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN YET RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS ADMITTED WITH A TIGHT STENOSIS IN THE RIGHT CORONARY ARTERY (RCA), A JR4 GUIDE CATHETER WAS USED AND A 0.014 HTF WIRE WERE INTRODUCED INTO THE RCA, THEN A 2.5 X 20 FIRE STAR BALLOON WAS SLIDE ON THE WIRE BUT IT BROKE BEFORE IT CAME OUT OF THE CATHETER. THE HUB CRACKED WHILE THE PHYSICIAN WAS SLIDING THE BALLOON OVER THE WIRE. THE HUB BROKE WITH MINIMAL FORCE. THE HUB OF THE BALLOON SEEMED TO BE SOFT. IT WAS PULLED BACK AND A 2.5 X 20 SPRINTER LEGEND WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SAFELY AND WITH NO COMPLICATIONS. THE PLASTIC PORTION OF THE SHAFT DID NOT KINK OR CRACK DURING THE PROCEDURE. THE METAL HYPOTUBE PORTION OF THE DEVICE DID NOT KINK OR CRACK DURING THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY AND THE DEVICE WAS RETURNED FOR ANALYSIS. ONE NON STERILE FIRESTAR 2.50 X 20 MM WAS RECEIVED IN TWO PARTS INSIDE A PLASTIC BAG. THE SEPARATED SECTION SEEMS TO BE BENT PRIOR THE SEPARATION. RESIDUES OF INFLATION MEDIUM WERE OBSERVED IN THE INFLATION LUMEN. THE SEPARATION IS AT 78 CM FROM THE DISTAL END. THE HUB WAS INSPECTED AND NO ANOMALIES WERE NOTED. DURING THE MICROSCOPIC ANALYSIS IT WAS FOUND THAT THE SEPARATED SECTION SEEMS TO BE BENT PRIOR THE SEPARATION. 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 CUSTOMER REPORTED COMPLAINT OF HUB CRACK WAS NOT CONFIRMED THROUGH FAILURE ANALYSIS; HOWEVER THE DEVICE WAS FOUND SEPARATED AT 78 CM FROM THE DISTAL END OF THE DEVICE. THE EXACT CAUSE OF THE DEVICE SEPARATION COULD NOT BE DETERMINED BUT UNDER MICROSCOPIC EVALUATION BENDS WERE IDENTIFIED. KINKING OR BENDING OF THE DEVICE MAY LEAD TO SEPARATION. THERE IS NO INDICATION IN THE REPORT OR THE ANALYSIS TO INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED. IN ADDITION, THE RECEIVED DEVICE WAS SEPARATED IN TWO AT 78CM FROM DISTAL. THE ANALYSIS OF THE DEVICE IS PENDING.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. AT THIS TIME THE PRODUCT'S RETURN IS PENDING. ADDITIONAL INFORMATION RECEIVED WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS ADMITTED WITH A TIGHT STENOSIS IN THE RIGHT CORONARY ARTERY (RCA), A JR4 GUIDE CATHETER WAS USED AND A 0.014 HTF WIRE WERE INTRODUCED INTO THE RCA, THEN A 2.5 X 20 FIRE STAR BALLOON WAS SLIDE ON THE WIRE BUT IT BROKE BEFORE IT CAME OUT OF THE CATHETER. THE HUB CRACKED WHILE THE PHYSICIAN WAS SLIDING THE BALLOON OVER THE WIRE. THE HUB BROKE WITH MINIMAL FORCE. THE HUB OF THE BALLOON SEEMED TO BE SOFT. IT WAS PULLED BACK AND A 2.5 X 20 SPRINTER LEGEND WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SAFELY AND WITH NO COMPLICATIONS. THE PLASTIC PORTION OF THE SHAFT DID NOT KINK OR CRACK DURING THE PROCEDURE. THE METAL HYPOTUBE PORTION OF THE DEVICE DID NOT KINK OR CRACK DURING THE PROCEDURE.

    Description of Event or Problem · 1

    APPROXIMATELY FOUR MONTHS POST INDEX PROCEDURE THE PATIENT HAD UNSTABLE ANGINA. CORONARY ANGIOGRAPHY REVEALED IN-STENT RESTENOSIS OF THE PROXIMAL SAPHENOUS VEIN GRAFT TO THE RIGHT CORONARY ARTERY. THE RESTENOSIS WAS TREATED WITH ANOTHER DRUG-ELUTING STENT. THE PATIENT WAS ENROLLED IN THE (B)(6) DUE TO NON-ST SEGMENT ELEVATION, ACUTE CORONARY SYNDROME, WITH FOUR VESSEL DISEASE. THE PATIENT HAD A DE NOVO, ANATOMICALLY COMPLEX VEIN GRAFT TO THE DISTAL RIGHT CORONARY ARTERY. THE LESION HAD THROMBUS PRESENT AND WAS 18MM IN LENGTH WITH 99% STENOSIS. THE VESSEL WAS 3.6MM IN DIAMETER. THE LESION WAS PRE-DILATED AND A 3.5 X 23MM CYPHER STENT WAS IMPLANTED AT 18ATM. THE FINAL PERCENTAGE OF STENOSIS WAS 3%. THE PATIENT'S MEDICATIONS INCLUDED ASPIRIN, STATINS, ACE INHIBITORS AND BETA-BLOCKERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRE STAR RX PTCA BALLOON CATHETER PTCA BALLOON CATHETERS (LOX) LOX CORDIS DE MEXICO 15154578

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR JR4 GUIDE CATHETER