BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERFLEX P3 PTA DILATATION CATHETER

    MDR report key: 2985152 · Received March 1, 2013

    Report

    Report Number
    9616099-2013-00108
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    January 1, 2008
    Report Date
    February 7, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE EVENT DATE IS BEING REPORTED AS (B)(6) 2008 AS THE EXACT DATE IS NOT KNOWN. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    AN ARTICLE FOUND DURING A LITERATURE SEARCH REPORTED A CASE WHERE AFTER REPEATED BALLOON INFLATIONS WITH A 4.0X40MM POWERFLEX BALLOON CATHETER IN THE MID SUPERFICIAL FEMORAL ARTERY, THE RADIOPAQUE CALCIFIED ATHEROMA DETACHED FROM THE ARTERIAL WALL AND MIGRATED PROXIMALLY. THE PROXIMAL MOVEMENT OF THE EMBOLUS WAS AUGMENTED DURING WITHDRAWAL OF THE BALLOON CATHETER. THE EMBOLUS WAS TOO EXTENSIVE TO BE PULLED THROUGH THE CATHETER SHEATH; THEREFORE, ANOTHER BALLOON CATHETER WAS INFLATED AT THE DISTAL END OF THE ATHEROMA TO ANCHOR IT AND THE EMBOLUS WAS DRAINED WITH THE BALLOON. THE PUNCTURE SITE WAS OPENED WIDER VIA A SURGICAL INCISION AND A HUGE CYLINDRICAL ATHEROMA THAT MEASURED 4CM IN LENGTH WAS SUCCESSFULLY REMOVED AT THE PUNCTURE SITE. THE PRODUCT WAS NOT RETURNED FOR INSPECTION. ADDITIONALLY AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, REVIEW OF THE MANUFACTURING RECORDS (DHR) COULD NOT BE PERFORMED. THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW AND POTENTIALLY A SIDE BRANCH. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS IS A WELL KNOWN COMPLICATION/SIDE EFFECT OF BALLOON ANGIOPLASTY AS LISTED IN THE INSTRUCTIONS FOR USE/IFU. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    DURING A LITERATURE SEARCH, THE FOLLOWING ARTICLE WAS NOTED: KIM ET AL BALLOON EMBOLECTOMY OF A CYLINDRICAL DISSECTED PLAQUE THAT COMPLICATED PERFORMING SUPERFICIAL FEMORAL ARTERY ANGIOPLASTY; KOREAN CIRC JOURNAL 2008: 38:335-338. THE ARTICLE REPORTED A CASE WHERE AFTER REPEATED BALLOON INFLATIONS WITH A 4.0 X 40 MM POWERFLEX BALLOON CATHETER IN THE MID SUPERFICIAL FEMORAL ARTERY, THE RADIOPAQUE CALCIFIED ATHEROMA DETACHED FROM THE ARTERIAL WALL AND MIGRATED PROXIMALLY. THE PROXIMAL MOVEMENT OF THE EMBOLUS WAS AUGMENTED WITH WITHDRAWING THE BALLOON. THE EMBOLUS WAS TOO EXTENSIVE TO BE PULLED THROUGH THE CATHETER SHEATH; THEREFORE, A 1.5 X 20 MM SPRINTER BALLOON (MEDTRONIC) WAS INFLATED AT THE DISTAL END OF THE ATHEROMA TO ANCHOR IT AND THE EMBOLUS WAS DRAINED WITH THE BALLOON. A HUGE CYLINDRICAL ATHEROMA THAT MEASURED 4 CM IN LENGTH WAS SUCCESSFULLY REMOVED AT THE PUNCTURE SITE WAS OPENED WIDER WITH SURGICAL INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90399 POWERFLEX P3 PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R MEDTRONIC 1.5 X 20 MM SPRINTER BALLOON CATHETER