BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3103002 · Received May 9, 2013

    Report

    Report Number
    2024168-2013-02899
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 16, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ABOVE RATED BURST PRESSURE. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED BALLOON SEPARATION WAS NOT CONFIRMED; HOWEVER, A SHAFT SEPARATION WAS NOTED. THE REPORTED DIFFICULTY DEFLATING COULD NOT BE TESTED AS THE SHAFT WAS ALREADY SEPARATED. BASED ON VISUAL AND DIMENSIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE RX TREK INSTRUCTION FOR USE (IFU) STATES: SUBMERGE THE BALLOON IN STERILE HEPARINIZED NORMAL SALINE DURING BALLOON PREPARATION TO ACTIVATE THE COATING. ADDITIONALLY, IT WAS REPORTED THAT THE CONTRAST SOLUTION WAS MIXED 40:60 CONTRAST/SALINE INSTEAD OF 60% CONTRAST MEDIUM DILUTED 1:1 WITH NORMAL SALINE AS INSTRUCTED IN THE IFU PREPARATION FOR USE SECTION. FURTHERMORE, IT WAS REPORTED THAT THE BALLOON WAS INFLATED TO 16 ATMOSPHERES. THE IFU WARNINGS SECTION STATES: BALLOON PRESSURE SHOULD NOT EXCEED THE RATED BURST PRESSURE (RBP). BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ABBOTT CLINICAL ANALYSIS OF CINE CONCLUDES THAT THE IMAGES ARE CONSISTENT WITH NO BALLOON DEFLATION AND SHAFT SEPARATION (BALLOON SEPARATION). IN SOME SCENES THERE APPEARS TO BE A STENT SHADOW IN PROXIMAL SAPHENOUS VEIN GRAFT EXTENDING AROUND AN ACUTE ANGLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE FOR TREATMENT OF A BYPASS GRAFT FROM THE AORTA TO THE MODERATELY TORTUOUS/MODERATELY CALCIFIED OBTUSE MARGINAL ARTERY, A 3.5X20 RX TREK DILATATION CATHETER WAS ADVANCED WITHOUT RESISTANCE VIA LEFT FEMORAL ACCESS USING A 5F SHEATH. DURING THE FIRST INFLATION, THE BALLOON WAS INFLATED TO 16 ATMOSPHERES. AN ATTEMPT WAS MADE TO DEFLATE THE BALLOON; HOWEVER, THE BALLOON DID NOT DEFLATE. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO DEFLATE THE BALLOON. THE INFLATION DEVICE WAS CHECKED AND WAS CONFIRMED TO BE OPERATING CORRECTLY. THE PHYSICIAN THEN PROCEEDED TO PULL BACK THE INFLATED BALLOON INTO THE 6F NON-ABBOTT GUIDE CATHETER. THE BALLOON SEPARATED FROM THE DELIVERY CATHETER AT THE ENTRANCE OF THE GUIDE CATHETER. THE DELIVERY CATHETER WAS WITHDRAWN FROM THE ANATOMY AND AN 8F SHEATH WAS PLACED IN THE RIGHT FEMORAL ARTERY. AN UNSPECIFIED SALVAGE DEVICE WAS INSERTED, BUT DUE TO A SHARP VESSEL ANGLE IT WAS NOT POSSIBLE FOR THE SALVAGE DEVICE TO REACH THE BALLOON. THE PHYSICIAN SWITCHED THE 5F SHEATH ON THE LEFT SIDE TO AN 8F SHEATH AND INSERTED THE SALVAGE DEVICE, WHICH REACHED THE BALLOON LOCATED IN THE AORTA. THE SALVAGE DEVICE WAS USED TO PUNCTURE THE BALLOON AND THE BALLOON RUPTURED. THE BALLOON AND THE SALVAGE DEVICE WERE WITHDRAWN FROM THE ANATOMY SUCCESSFULLY. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. THE PATIENT IS REPORTED AS DOING FINE. REPORTEDLY, THE DEVICE WAS NOT PREPARED PER THE INSTRUCTIONS FOR USE PRIOR TO USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203715 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 21212G1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE CATHETER: MEDTRONIC ZUMA AL1 6F