BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC TRAVELER CORONARY DILATATION CATHETER

    MDR report key: 7686482 · Received July 13, 2018

    Report

    Report Number
    2024168-2018-05436
    Event Type
    Injury
    Date Received
    July 13, 2018
    Date of Event
    June 20, 2018
    Report Date
    July 30, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. WHEN THIS FAILED, THE BDC WAS WITHDRAWN WITH EXCESSIVE FORCE FROM THE ANATOMY AND A DISTAL SHAFT SEPARATION OCCURRED. THE GC WAS REMOVED. FORCEPS WERE USED TO MAINTAIN THE PROXIMAL END OF THE SEPARATED DISTAL SHAFT OUTSIDE OF THE PATIENT ANATOMY WHILE A NEEDLE WAS ADVANCED TO THE TIP OF THE SHEATH TO RUPTURE THE BALLOON. THE DISTAL SHAFT WAS REMOVED MANUALLY BY HAND, NO FURTHER INTERVENTION WAS REQUIRED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THE PROCEDURE TIME WAS DELAYED BY 20 MINUTES. NO ADDITIONAL INFORMATION WAS PROVIDED. CONCOMITANT MEDICAL PRODUCTS: DIL CATH: NSE; GUIDE WIRE: SION BLUE; GUIDE CATH: HYPERION; STENT: RESOLUTE ONYX, XIENCE SIERRA. (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE NC TRAVELER IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED KINKS AND SEPARATION WERE CONFIRMED. THE REPORTED DEFLATION ISSUES, DIFFICULTY POSITIONING AND REMOVING THE DEVICE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT DUE TO THE CONDITION OF THE RETURNED DEVICE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. IT SHOULD BE NOTED CORONARY DILATATION CATHETERS, NC TREK RX, INSTRUCTION FOR USE (IFU) STATES: DO NOT USE, OR ATTEMPT TO STRAIGHTEN, A CATHETER IF THE SHAFT HAS BECOME BENT OR KINKED; THIS MAY RESULT IN THE SHAFT BREAKING. INSTEAD, PREPARE A NEW CATHETER. ALSO STATED IN THE IFU: BALLOON PRESSURE SHOULD NOT EXCEED THE RATED BURST PRESSURE (RBP). THE MAXIMUM RBP FOR THE NC TREK IS 18 ATMS. ADDITIONALLY, THE IFU STATES: 60% CONTRAST MEDIUM DILUTED 1:1 WITH NORMAL SALINE. THE IFU ALSO STATES: IF RESISTANCE IS FELT, DETERMINE THE CAUSE BEFORE PROCEEDING. CONTINUING TO ADVANCE OR RETRACT THE CATHETER WHILE UNDER RESISTANCE MAY RESULT IN DAMAGE TO THE VESSELS AND / OR DAMAGE / SEPARATION OF THE CATHETER. THE REPORTED SEPARATION, KINKS AND DIFFICULT POSITIONING THE DEVICE, DIFFICULTY REMOVING THE DEVICE FROM THE GUIDING CATHETER, FOREIGN BODY REMOVAL, ADDITIONAL TREATMENT AND ADDITIONAL DEFLATION ISSUE (BALLOON PARTIALLY DEFLATED) APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. THE REPORTED DEFLATION ISSUE APPEAR TO BE RELATED TO USER ERROR. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECTS TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TOTALLY OCCLUDED LESION FROM THE LEFT MAIN CORONARY ARTERY (LMT) TO THE LEFT CIRCUMFLEX CORONARY ARTERY (LCX). A DISSECTION WAS CAUSED IN THE DISTAL LCX BY THE GUIDE CATHETER (GC), CAUSING TOTAL OCCLUSION OF THE LCX. A 4.0 MM NON-ABBOTT STENT WAS DEPLOYED TO TREAT THE DISSECTION. FOLLOWING PREPARATION WITH AN INCORRECT CONTRACT MIXTURE, A 5.00X8 MM NC TRAVELER BALLOON DILATATION CATHETER (BDC) WAS INFLATED TO 22 ATMOSPHERES (ATM) FOR POST-DILATATION OF THE STENT. FOLLOWING 4 INFLATIONS, THERE WERE NO REPORTED PROBLEMS WITH DEFLATION OF THE BALLOON. THE BDC WAS DILATED TO 4 ATM AT THE LMT-LCX TO AID ADVANCEMENT OF AN UNSPECIFIED GUIDE WIRE THROUGH THE STENT AND WAS THEN REMOVED FROM THE ANATOMY. POST ADVANCEMENT OF AN UNSPECIFIED BDC, THE NC TRAVELER BDC WAS RE-ADVANCED FOR A KISSING BALLOON TECHNIQUE. THE NC TRAVELER BDC MET RESISTANCE WITH THE UNSPECIFIED BDC, BUT CONTINUED TO BE ADVANCED AND THE PROXIMAL SHAFT KINKED AT TWO POINTS. THE BDC WAS INFLATED ONCE TO 22 ATM AT THE LMT. THE BALLOON WAS NOT FULLY DEFLATED PRIOR TO WITHDRAWAL DUE TO THE PHYSICIAN WANTING TO LIMIT ISCHEMIA TIME AT THE LMT. REPORTEDLY, THE BALLOON DEFLATION WAS SLOW. ON REMOVAL OF THE BDC WITH THE BALLOON PARTIALLY DEFLATED, RESISTANCE WITH THE GC WAS FELT. THE BDC AND THE GC WERE WITHDRAWN TO THE AORTA WHERE THE BALLOON OF THE BDC WAS ATTEMPTED TO BE FURTHER INFLATED AND DEFLATED. THE BALLOON FAILED TO FULLY DEFLATE. THE BDC WAS WITHDRAWN PARTIALLY DEFLATED TO THE DISTAL SHEATH. THE HUB OF THE BDC AND THE TIP OF THE GC WERE CUT. THE GC TIP MESH WAS USED TO TRY AND RUPTURE THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530016 NC TRAVELER CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 80104G1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention