BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3122854 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03305
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS RECEIVED FOR ANALYSIS. THERE WAS A COMPLETE CIRCUMFERENTIAL TEAR OF THE BALLOON 10CM FROM THE PROXIMAL BALLOON BOND. THE INNER SHAFT WAS DETACHED ADJACENT TO THE BI-COMPONENT WELD. THE INNER SHAFT FRACTURE FACE WAS JAGGED AND STRETCHED, 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 DISTAL PORTION OF THE BALLOON, INNER SHAFT, MARKERBANDS AND DISTAL TIP WERE NOT RETURNED FOR ANALYSIS, WHICH IS CONSISTENT WITH THE REPORTED INFORMATION. THE REPORTED BALLOON BURST AND SEPARATION WERE CONFIRMED; HOWEVER, THERE WAS NO EVIDENCE THAT THIS WAS ATTRIBUTABLE TO ANY PRODUCT QUALITY DEFICIENCIES. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE AND SEPARATION OCCURRED. THE TARGET LESION WAS LOCATED AT THE LEFT ANTERIOR DESCENDING ARTERY. UPON INFLATION OF THE 20MM X 2.50MM NC QUANTUM OTW BALLOON CATHETER, THE BALLOON RUPTURED AT 18 ATMS AND THE SHAFT SEPARATED. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE PORTION OF THE BALLOON THAT REMAINED INSIDE THE PATIENT'S BODY BUT FAILED. HENCE, AN EMERGENCY OPEN HEART SURGERY WAS PERFORMED TO RETRIEVE THE REMAINED PORTION OF THE BALLOON. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE AND SEPARATION OCCURRED. THE TARGET LESION WAS LOCATED AT THE LEFT ANTERIOR DESCENDING ARTERY. UPON INFLATION OF THE 20MM X 2.50MM NC QUANTUM OTW BALLOON CATHETER, THE BALLOON RUPTURED AT 18 ATMS AND THE SHAFT SEPARATED. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE PORTION OF THE BALLOON THAT REMAINED INSIDE THE PATIENT'S BODY BUT FAILED. HENCE, AN EMERGENCY OPEN HEART SURGERY WAS PERFORMED TO RETRIEVE THE REMAINED PORTION OF THE BALLOON. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223877 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912520250 15890205

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention