BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABER PTA DILATATION CATHETER

    MDR report key: 4111395 · Received September 23, 2014

    Report

    Report Number
    9616099-2014-00620
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K971010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AFTER PRE-DILATION, THE 90 CM. SABER 6MM. X 2 CM. BALLOON CATHETER (BC) RUPTURED AT NOMINAL PRESSURE. THE PRODUCT WAS REMOVED SUCCESSFULLY FROM THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED. ANOTHER NEW SABER BC 6 X 40 MM. BC WAS USED INSTEAD. THE PROCEDURE FINISHED SUCCESSFULLY. THE TARGET LESION WAS THE RIGHT ILIAC ARTERY. THE LESION WAS REPORTED TO BE MODERATELY CALCIFIED, TORTUOUS, AND A 100% STENOSED (CHRONIC TOTAL OCCLUSION). THE APPROACH WAS MADE WITH A 4 FR. NON-CORDIS SHEATH INTRODUCER. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. THE DEVICE WAS RETURNED FOR ANALYSIS. ONE NON STERILE CATHETER PTA SABER 6MM2CM 90 WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE BALLOON WAS RECEIVED DEFLATED AND APPEAR HAVE BEEN INFLATED. NO OTHER DAMAGES WERE NOTED IN THE DEVICE. LEAK TEST WAS PERFORMED AND A PINHOLE WAS NOTED NEAR THE DISTAL SECTION OF THE BALLOON. SEM RESULTS SHOWED THAT THE EXTERNAL SURFACE PRESENTED EVIDENCE OF ABRASION MARKS THAT COULD BE RELATED TO THE BALLOON PIN HOLE. MARKER BANDS DID NOT PRESENTED ANY EVIDENCE OF DAMAGES. NO OTHER ANOMALIES WERE FOUND DURING THE ANALYSIS. REVIEW OF LOT 17025878 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED BALLOON BURST AT/BELOW RBP WAS CONFIRMED THROUGH ANALYSIS OF THE RETURNED DEVICE. THE EXACT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, VESSEL CHARACTERISTICS (CALCIFICATION, TORTUOSITY AND STENOSIS) MAY HAVE CONTRIBUTED TO THE BALLOON BURST AS EVIDENCED BY ABRASION MARKS ON THE EXTERNAL SURFACE OF THE BALLOON. NEITHER THE DHR NOR THE ANALYSIS SUGGEST THAT THE BALLOON BURST 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

    CONCOMITANT PRODUCTS: CSI: 4FR, TERUMO; SABER 6MM. X 2 CM. BALLOON CATHETER. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AFTER PRE-DILATION, THE 90 CM. SABER 6MM. X 2 CM. BALLOON CATHETER (BC) RUPTURED AT NOMINAL PRESSURE. THEREFORE, THE PRODUCT WAS REMOVED SUCCESSFULLY FROM THE PATIENT. ANOTHER NEW SABER BC 6 X 40 MM. BC WAS USED INSTEAD. THE PROCEDURE FINISHED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS CLINICALLY USED AND IT WILL BE RETURNED FOR ANALYSIS. THE TARGET LESION WAS THE RIGHT ILIAC ARTERY. THE LESION WAS REPORTED TO BE: MODERATELY CALCIFIED, TORTUOUS, AND A 100% STENOSIS CHRONIC TOTAL OCCLUSION (CTO). AN APPROACH WAS MADE WITH A 4 FR. NON-CORDIS SHEATH INTRODUCER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590413 SABER PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO 17025878

    Patients

    Seq Age Sex Outcome Treatment
    1