BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX P3 PTA DILATATION CATHETER

    MDR report key: 3111160 · Received May 14, 2013

    Report

    Report Number
    9616099-2013-00294
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 18, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED BY AN AFFILIATE, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE LEFT EXTERNAL ILIAC ARTERY WHICH WAS DE NOVO, HEAVILY CALCIFIED AND MODERATELY TORTUOUS WITH UNKNOWN STENOSIS, A POWERFLEX P3 RUPTURED. CONTRALATERAL APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY AND A GUIDING SHEATH WAS DELIVERED AND THE LESION WAS CROSSED WITH A GUIDEWIRE. A STENT (SMART CONTROL SIZE 10MM) WAS PLACED AT THE LESION. THE POWERFLEX P3 WAS INSERTED THROUGH THE ROTATING HEMOSTATIC VALVE AND GUIDE CATHETER WITHOUT DIFFICULTY THEN DELIVERED TO THE LESION FOR POST DILATION OF THE STENT. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE POWERFLEX P3 WAS INFLATED WITH AN EVEREST INDEFLATOR WHICH HAD PREVIOUSLY BEEN USED SUCCESSFULLY WITH OTHER DEVICES; HOWEVER, THE PRESSURE DID NOT INCREASE ABOVE 4 ATMOSPHERES. THE BALLOON RUPTURE WAS CONFIRMED BY LEAKAGE OF CONTRAST MEDIUM. IT IS UNKNOWN IF THE BALLOON RUPTURED DURING ITS INITIAL INFLATION. THE POWERFLEX P3 WAS REMOVED FROM THE PATIENT AND A NEW POWERFLEX P3 WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE PREPPED NORMALLY AND MAINTAINED NEGATIVE PRESSURE. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THE CONTRAST MEDIA USED AND CONTRAST TO SALINE RATIO USED IS UNKNOWN. THERE WAS NO PATIENT INJURY REPORTED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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 REPORTED BALLOON BURST COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THE DEVICE PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE PRIOR TO USE. THERE ARE VESSEL CHARACTERISTICS (HEAVY CALCIFICATION AND MODERATE TORTUOSITY) THAT MAY HAVE CONTRIBUTED TO THE DIFFICULTY EXPERIENCED BY THE CUSTOMER. NEITHER THE DHR NOR THE EVENT DESCRIPTION SUGGESTS THAT THE BALLOON BURST COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE DEVICE. THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    AS REPORTED BY AN AFFILIATE, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), A POWERFLEX P3 RUPTURED. THEREFORE, THE POWERFLEX WAS REMOVED FROM THE PATIENT AND A NEW POWERFLEX WAS USED INSTEAD. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE PREPPED NORMALLY, MAINTAIN NEGATIVE PRESSURE. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. IT IS UNKNOWN THE CONTRAST MEDIA USED OR THE CONTRAST TO SALINE RATIO USED. CONTRALATERAL APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY. A GUIDING SHEATH (DESTINATION 6F) WAS DELIVERED TO THE LESION AND THE LESION WAS CROSSED WITH A GUIDEWIRE (CHEVALIER). A STENT (SMART CONTROL SIZE 10MM) WAS PLACED AT THE LESION. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE POWERFLEX THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THE POWERFLEX (8.0/40MM 135CM) WAS DELIVERED TO THE LESION FOR POST DILATION AND IT CROSSED THE LESION WITH NO DIFFICULTIES. THE POWERFLEX WAS INFLATED WITH AN EVEREST INDEFLATOR AT THE LESION BUT THE PRESSURE DID NOT INCREASE ABOVE 4ATM AND THE BALLOON RUPTURE WAS CONFIRMED BY CONTRAST MEDIUM LEAKAGE. IT IS UNKNOWN IF THE BALLOON RUPTURED DURING ITS INITIAL INFLATION. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE TARGET LESION WAS THE LEFT EXTERNAL ILIAC ARTERY. THE LESION WAS A DE NOVO BUT WAS HEAVILY CALCIFIED AND MODERATELY TORTUOUS. THE % OF THE STENOSIS WAS UNKNOWN. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212088 POWERFLEX P3 PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA 15444154

    Patients

    Seq Age Sex Outcome Treatment
    1