BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2923235 · Received January 18, 2013

    Report

    Report Number
    2024168-2013-00343
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 25, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED BALLOON RUPTURE AND BALLOON DETACHMENT WERE CONFIRMED. THE REPORTED DIFFICULTY TO REMOVE COULD NOT BE REPLICATED AS THE RETURNED DEVICE WAS NOT RETURNED IN A CONDITION IN WHICH THE TEST COULD BE PERFORMED. BASED ON ANALYSIS OF THE RETURNED DEVICE, SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS, AND CINE REVIEW THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL AND FOLLOW-UP REPORTS, THE FOLLOWING INFORMATION WAS RECEIVED: TARGET LESION WAS ORIGINALLY REPORTED TO BE HEAVILY CALCIFIED, BUT NEW INFORMATION INDICATES IT WAS A NON-CALCIFIED, OSTIAL LESION OF THE LEFT MAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEAVILY CALCIFIED PROXIMAL LEFT MAIN STENTING PROCEDURE, THE PATIENT WAS PLACED ON AN INTRA-AORTIC BALLOON PUMP FOR SUPPORT. AFTER LESION PRE-DILATATION, A NON-ABBOTT STENT WAS DEPLOYED. DURING POST-DILATATION WITH A NC TREK RX AT 15 ATMOSPHERES (ATM), THE BALLOON RUPTURED. REMOVAL OF THE BALLOON DILATATION CATHETER WAS DIFFICULT AND DURING REMOVAL, THE TIP OF THE BALLOON CAUGHT WITH THE IMPLANTED STENT AND TORE OFF. ANGIOGRAPHY SHOWED THE BALLOON MARKER WAS STILL ON THE GUIDE WIRE. A GOOSE NECK SNARE WAS ADVANCED TO REMOVE THE SEPARATED PORTION OF THE BALLOON (APPROX. 4MM), BUT CAUGHT ON THE STENT PULLING THE STENT FROM POSITION. THE SNARE WAS ABLE TO CAPTURE THE BALLOON FRAGMENT AND THE STENT, BUT DURING REMOVAL, BOTH WERE LOST IN THE FEMORAL ARTERY. ANOTHER NON-ABBOTT STENT WAS DEPLOYED AND POST-DILATED WITH GOOD WALL APPOSITION. THE PATIENT WAS TAKEN TO THE CORONARY CARE UNIT IN STABLE CONDITION. THE PATIENT IS PENDING REMOVAL OF THE SEPARATED BALLOON AND THE STENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27265 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2072661

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R STENT: BIOMATRIX 4.0X11MM