BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

    MDR report key: 4210497 · Received October 29, 2014

    Report

    Report Number
    9616099-2014-00697
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 30, 2014
    Report Date
    December 4, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    LIT
    PMA / PMN Number
    K112797
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE 135 CM. POWERFLEXPRO 8 MM. X 4 CM. BALLOON CATHETER (BC) RUPTURED DURING THE INITIAL INFLATION. THEREFORE, IT WAS REMOVED FROM THE PATIENT AND ANOTHER NEW BALLOON WAS USED INSTEAD. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS ILIAC ARTERY. THE LESION WAS REPORTED TO BE HEAVILY CALCIFIED AND NOT TORTUOUS. THE RATE OF STENOSIS WAS UNKNOWN. THE LESION WAS CROSSED WITH AN UNKNOWN GUIDEWIRE. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING OR DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NO PROBLEMS NOTED. THERE WERE NO KINKS OR BENDS NOTED UPON INSPECTION PRIOR TO USE. AN UNKNOWN INFLATION DEVICE WAS USED FOR THE PROCEDURE AND WAS USED SUBSEQUENTLY WITH OTHER DEVICES. THERE WAS NO INFORMATION PROVIDED REGARDING CONTRAST OR THE CONTRAST TO SALINE RATIO USED. THERE WAS NO REPORTED DIFFICULTY OR RESISTANCE/FRICTION REPORTED DURING ADVANCEMENT THROUGH THE GUIDING CATHETER OR ACCESSING THE LESION. THE CATHETER DID NOT KINK DURING USE. THE CATHETER WAS NOT EVER IN AN ACUTE BEND. THE CATHETER WAS REMOVED EASILY FROM THE PATIENT AND WAS INTACT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE DEVICE WAS RETURNED FOR ANALYSIS. ONE NON STERILE POWERFLEX PRO 8MM4CM 135 WAS RECEIVED COILED INSIDE A PLASTIC BAG. AN AXIAL BURST WAS NOTED IN THE BALLOON. NO OTHER DAMAGES WERE NOTED. FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE BALLOON CONDITIONS. SEM SHOWED THAT THE EXTERNAL SURFACE PRESENTED EVIDENCE OF ABRASION MARKS THAT COULD BE RELATED TO THE BALLOON BURST. THE INTERNAL SURFACE AND MARKER BANDS DID NOT PRESENTED ANY EVIDENCE OF DAMAGES. NO OTHER ANOMALIES WERE FOUND DURING THE ANALYSIS. REVIEW OF LOT 15835851 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED BALLOON BURST 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 (HEAVY CALCIFICATION) MAY HAVE CONTRIBUTED TO THE DIFFICULTY EXPERIENCED BY THE CUSTOMER AS EVIDENCED BY ABRASION MARKS NOTED ON THE EXTERNAL SURFACE OF THE BALLOON DURING ANALYSIS. NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE BALLOON BURST EXPERIENCED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    AS REPORTED, THE 135 CM. POWERFLEXPRO 8 MM. X 4 CM. BALLOON CATHETER (BC) RUPTURED DURING THE INITIAL INFLATION. THEREFORE IT WAS REMOVED FROM THE PATIENT AND ANOTHER NEW BALLOON WAS USED INSTEAD. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS CLINICALLY USED AND IT WILL BE RETURNED FOR ANALYSIS. THE TARGET LESION WAS ILIAC ARTERY. THE LESION WAS REPORTED TO BE: HEAVILY CALCIFIED AND NOT TORTUOUS. THE RATE OF STENOSIS WAS UNKNOWN. THE LESION WAS CROSSED WITH AN UNKNOWN GUIDEWIRE. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING OR DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NO PROBLEMS NOTED. THERE WERE NO KINKS OR BENDS NOTED UPON INSPECTION PRIOR TO USE. AN UNKNOWN INFLATION DEVICE WAS USED FOR THE PROCEDURE AND WAS USED SUBSEQUENTLY WITH OTHER DEVICES. THERE WAS NO INFORMATION PROVIDED REGARDING CONTRAST OR THE CONTRAST TO SALINE RATIO USED. THERE WAS NO REPORTED DIFFICULTY OR RESISTANCE/FRICTION REPORTED DURING ADVANCEMENT THROUGH THE GUIDING CATHETER OR ACCESSING THE LESION. THE CATHETER DID NOT KINK DURING USE. THE CATHETER WAS NOT EVER IN AN ACUTE BEND. THE CATHETER WAS REMOVED EASILY FROM THE PATIENT AND WAS INTACT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691773 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER PTA CATHETERS (LIT) LIT CORDIS CORPORATION 4400804X 15835851

    Patients

    Seq Age Sex Outcome Treatment
    1