BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX¿

    MDR report key: 2992571 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01228
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER NAME CORRECTED FROM BSC - (B)(4) TO BSC - (B)(4). DEVICE EVALUATED BY MANUFACTURER: VISUAL EXAMINATION SHOWED THERE WAS BLOOD IN THE BALLOON AND INFLATION LUMEN. THE DISTAL END OF THE BALLOON WAS BUNCHED UP OVER THE DISTAL TIP. THERE WAS A COMPLETE CIRCUMFERENTIAL TEAR OF THE BALLOON 15MM FROM THE PROXIMAL BALLOON BOND, CONFIRMING THE REPORTED BALLOON BURST. THE INNER SHAFT WAS SEPARATED AND STRETCHED 3MM PROXIMALLY FROM THE PROXIMAL BALLOON BOND. THE INNER SHAFT FRACTURE FACES WERE JAGGED, STRETCHED AND BUCKLED, WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD. MAGNIFIED INSPECTION OF THE INNER SHAFT FRACTURE SURFACE PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE SEPARATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE AND DETACHMENT OCCURRED. THE 70% STENOSED AND HEAVILY CALCIFIED LONG LESION LOCATED IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. THE VESSEL WAS NOT VERY TORTUOUS. A BMW WIRE CROSSED THE LESION AFTER A RUNTHROUGH WIRE FAILED. THE APEX 3.0X20 WAS USED TO PRE-DILATE THE LESION AT A MAX OF ABOUT TEN TO TWELVE ATMOSPHERES. ON THE 3RD INFLATION (IN THE PROXIMAL ASPECT OF THE LESION) IT RUPTURED. THE PHYSICIAN RECALLS SEEING THE PRESSURE LEAK OUT OF THE INFLATION DEVICE AND IMMEDIATELY WENT NEGATIVE BUT WAS NOT ON FLUORO WHEN HE NOTED THIS SO HE DOES NOT KNOW IF THE BALLOON HAD A PINHOLE PERFORATION OR NOT. ANGIO SHOWED NO STAIN OF THE VESSEL AND PATIENT WAS ASYMPTOMATIC. AS THE PHYSICIAN WAS REMOVING THE BALLOON IT SEEMED TO "GIVE" SOMEWHERE IN THE GUIDE BUT THERE WAS NO RESISTANCE AT ALL TO WITHDRAWING THE BALLOON FROM THE VESSEL AND IT WAS NOTED THAT THE HYPOTUBE AND A PORTION OF THE DISTAL TUBING CAME OUT WITHOUT THE BALLOON. THE PHYSICIAN SAW THE BALLOON MARKER A FEW CM FROM THE DISTAL TIP OF THE GUIDE CATHETER. A SECOND GUIDE WIRE WAS PLACED ALONGSIDE THE BALLOON FRAGMENT AND ANOTHER BALLOON WAS ADVANCED DISTAL TO THE FRAGMENT. THE FRAGMENT WAS ABLE TO BE CAPTURED IN THE GUIDE CATHETER AND THE GUIDE CATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE AND DETACHMENT OCCURRED. THE 70% STENOSED AND HEAVILY CALCIFIED LONG LESION LOCATED IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. THE VESSEL WAS NOT VERY TORTUOUS. A BMW WIRE CROSSED THE LESION AFTER A RUNTHROUGH WIRE FAILED. THE APEX 3.0X20 WAS USED TO PRE-DILATE THE LESION AT A MAX OF ABOUT TEN TO TWELVE ATMOSPHERES. ON THE 3RD INFLATION (IN THE PROXIMAL ASPECT OF THE LESION) IT RUPTURED. THE PHYSICIAN RECALLS SEEING THE PRESSURE LEAK OUT OF THE INFLATION DEVICE AND IMMEDIATELY WENT NEGATIVE BUT WAS NOT ON FLUORO WHEN HE NOTED THIS SO HE DOES NOT KNOW IF THE BALLOON HAD A PINHOLE PERFORATION OR NOT. ANGIO SHOWED NO STAIN OF THE VESSEL AND PATIENT WAS ASYMPTOMATIC. AS THE PHYSICIAN WAS REMOVING THE BALLOON IT SEEMED TO "GIVE" SOMEWHERE IN THE GUIDE BUT THERE WAS NO RESISTANCE AT ALL TO WITHDRAWING THE BALLOON FROM THE VESSEL AND IT WAS NOTED THAT THE HYPOTUBE AND A PORTION OF THE DISTAL TUBING CAME OUT WITHOUT THE BALLOON. THE PHYSICIAN SAW THE BALLOON MARKER A FEW CM FROM THE DISTAL TIP OF THE GUIDE CATHETER. A SECOND GUIDE WIRE WAS PLACED ALONGSIDE THE BALLOON FRAGMENT AND ANOTHER BALLOON WAS ADVANCED DISTAL TO THE FRAGMENT. THE FRAGMENT WAS ABLE TO BE CAPTURED IN THE GUIDE CATHETER AND THE GUIDE CATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98191 APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493895930300 15417600

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention