BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 2972454 · Received February 21, 2013

    Report

    Report Number
    2134265-2013-00785
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE NC QUANTUM APEX CATHETER WAS RECEIVED AND COMPLETE SEPARATION OF THE HYPOTUBE WAS NOTED. THE HYPOTUBE SEPARATION WAS 75CM FROM THE DISTAL TIP. THE HYPOTUBE FRACTURE SURFACE WAS OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. THERE WAS NO OTHER DAMAGE OR IRREGULARITIES. 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 A PERCUTANEOUS CORONARY INTERVENTION, A CATHETER SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS GAINED VIA THE RADIAL ARTERY. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. THE PROCEDURE WAS TREATING IN-STENT RESTENOSIS OF AN UNKNOWN MANUFACTURER'S STENT. AN UNSPECIFIED MANUFACTURER'S DRUG ELUTING STENT WAS PLACED THEN A 3.25 X 12 MM NC QUANTUM APEX BALLOON CATHETER WAS USED WITH A NON BSC WIRE AND A NON BSC GUIDE CATHETER. DURING ADVANCEMENT OF THE QUANTUM APEX BALLOON CATHETER THROUGH THE GUIDE CATHETER THE PHYSICIAN FELT THE QUANTUM APEX BALLOON CATHETER TO BE "FREE". IT WAS THEN NOTED THAT THE DISTAL HALF OF THE BALLOON DETACHED INSIDE THE GUIDE CATHETER. THE DETACHED PIECE WAS RETRIEVED BY INFLATING A 1.5 MM BALLOON CATHETER INSIDE THE GUIDE CATHETER AND PINNING THE DETACHED PIECE TO THE GUIDE CATHETER. THE QUANTUM APEX BALLOON CATHETER AND GUIDE CATHETER WERE REMOVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A CATHETER SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS GAINED VIA THE RADIAL ARTERY. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. THE PROCEDURE WAS TREATING IN-STENT RESTENOSIS OF AN UNKNOWN MANUFACTURER'S STENT. AN UNSPECIFIED MANUFACTURER'S DRUG ELUTING STENT WAS PLACED THEN A 3.25X12MM NC QUANTUM APEX BALLOON CATHETER WAS USED WITH A NON BSC WIRE AND A NON BSC GUIDE CATHETER. DURING ADVANCEMENT OF THE QUANTUM APEX BALLOON CATHETER THROUGH THE GUIDE CATHETER THE PHYSICIAN FELT THE QUANTUM APEX BALLOON CATHETER TO BE ''FREE.'' IT WAS THEN NOTED THAT THE DISTAL HALF OF THE BALLOON DETACHED INSIDE THE GUIDE CATHETER. THE DETACHED PIECE WAS RETRIEVED BY INFLATING A 1.5MM BALLOON CATHETER INSIDE THE GUIDE CATHETER AND PINNING THE DETACHED PIECE TO THE GUIDE CATHETER. THE QUANTUM APEX BALLOON CATHETER AND GUIDE CATHETER WERE REMOVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75890 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912412320 15767375

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention