BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX P3 F5 8X8 80

    MDR report key: 7141940 · Received December 22, 2017

    Report

    Report Number
    9616099-2017-01713
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    December 4, 2017
    Report Date
    February 6, 2018
    Manufacturer
    CORDIS CASHEL
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING TELEPHONE AND FAX NUMBERS OF CORDIS CASHEL ARE RESPECTIVELY,(B)(4).THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING INFLATION OF AN 8X80MM 80CM POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER IN A FISTULA CASE, THE BALLOON RUPTURED AFTER THE DOCTOR INSERTED THE BALLOON THROUGH THE SHEATH AND WHEN THEY INFLATED THE BALLOON UP TO FOUR (4) ATMOSPHERES (ATM). THE PATIENT DID FINE. THERE WAS NO CALCIFICATION AND THE VESSEL WAS NOT TORTUOUS. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER AND NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE CONTRAST TO SALINE RATIO WAS 50/50. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE MAXIMUM INFLATION PRESSURE WAS 4 ATM. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED AND WAS EASILY REMOVED. A NON-STERILE POWERFLEX P3 F5 8X8 80 WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE BALLOON WAS RECEIVED DEFLATED AND IT APPEARED TO HAVE BEEN PREVIOUSLY INFLATED. NO OTHER ANOMALIES WERE OBSERVED. A FUNCTIONAL TEST FOR LEAKAGE WAS PERFORMED ON THE RECEIVED UNIT. A GUIDEWIRE WAS INSERT THROUGH IT, AND AN INFLATION DEVICE WAS ATTACHED TO THE STOPCOCK. NEGATIVE PRESSURE WAS APPLIED TO PURGE THE BALLOON OF AIR. WITH THE STOPCOCK IN A CLOSED POSITION, PRESSURE WAS APPLIED TO THE INFLATION DEVICE/SYSTEM TO INFLATE THE BALLOON AND A LEAKAGE WAS OBSERVED CLOSE TO THE PROXIMAL SECTION OF THE BALLOON BEFORE NOMINAL PRESSURE. SEM RESULTS SHOWED THAT THE EXTERNAL SURFACE OF THE BALLOON PRESENTED EVIDENCE OF SCRATCHES AND ABRASIONS NEAR THE BALLOON RUPTURE, AND IT¿S VERY LIKELY THAT THE SAME FACTORS THAT CAUSED THE SCRATCH AND ABRASION MARKS ON THE BALLOON¿S OUTER SURFACE COULD HAVE ALSO CONTRIBUTED TO THE RUPTURE FOUND ON THE RECEIVED BALLOON. THE INTERNAL SURFACE DID NOT PRESENT ANY EVIDENCE OF DAMAGES. A DEVICE HISTORY RECORD (DHR) REVIEW OF LOT 17487806 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿BALLOON BURST - AT/BELOW RBP¿ WAS CONFIRMED THROUGH ANALYSIS OF THE RETURNED DEVICE. HOWEVER, THE EXACT CAUSE OF THE RUPTURE CONDITION OF THE BALLOON COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, VESSEL CHARACTERISTICS OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT AS EVIDENCED BY THE SCRATCH MARKS AND ABRASIONS FOUND DURING SEM ANALYSIS. ACCORDING TO THE INSTRUCTIONS FOR USE, WHICH IS NOT INTENDED AS A MITIGATION, ¿THE RATED BURST PRESSURE IS BASED ON THE RESULTS OF IN VITRO TESTING. AT LEAST 99.9% OF THE BALLOONS (WITH A 95% CONFIDENCE) WILL NOT BURST AT OR BELOW THEIR RATED BURST PRESSURE. USE OF A PRESSURE MONITORING DEVICE IS RECOMMENDED TO PREVENT OVER-PRESSURIZATION. DO NOT EXCEED THE RATED BURST PRESSURE RECOMMENDED ON THE LABEL. PRIOR TO ANGIOPLASTY, THE CATHETER SHOULD BE EXAMINED TO VERIFY FUNCTIONALITY AND ENSURE THAT ITS SIZE AND SHAPE ARE SUITABLE FOR THE SPECIFIC PROCEDURE FOR WHICH IT IS TO BE USED.¿ NEITHER THE PRODUCT ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE FAILURES REPORTED COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING INFLATION OF A 5F 8X8 80 POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER IN A FISTULA CASE, THE BALLOON RUPTURED AFTER THE DOCTOR INSERTED THE BALLOON THROUGH THE SHEATH AND WHEN THEY INFLATED THE POWERFLEX UP TO 4 ATMOSPHERES (ATM). THE PATIENT DID FINE AND THEY THE BALLOON WILL BE RETURNED. THERE WAS NO CALCIFICATION AND THE VESSEL WAS NOT TORTUOUS. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER AND NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE CONTRAST TO SALINE RATIO WAS 50/50. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE MAXIMUM INFLATION PRESSURE WAS 4 ATM. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED AND WAS EASILY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922713 POWERFLEX P3 F5 8X8 80 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER LIT CORDIS CASHEL N/A 17487806

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR