BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 3210117 · Received July 8, 2013

    Report

    Report Number
    2024168-2013-04254
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED PHYSICAL RESISTANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. THE REPORTED INFLATION ISSUE/DEFLATION ISSUE AND 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, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES OR EXCEPTIONS 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. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE, IN THE PREPARATION FOR USE SECTION STATES TO SUBMERGE THE BALLOON IN STERILE HEPARINIZED NORMAL SALINE DURING BALLOON PREPARATION TO ACTIVATE THE COATING. ADDITIONALLY, IN THE WARNINGS SECTION, IT STATES THAT 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4) - AGAINST RESISTANCE; INCORRECT PREPARATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 2.0X15 RX MINI TREK BALLOON WAS ADVANCED WITH RESISTANCE TO THE TARGET SITE IN THE RIGHT CORONARY ARTERY VIA RADIAL ACCESS. THE BALLOON WAS INFLATED ONE TIME TO UNSPECIFIED ATMOSPHERES. INFLATION TOOK LONGER THAN USUAL. DURING DEFLATION OF THE BALLOON, NEGATIVE PRESSURE WAS HELD FOR 30 SECONDS BUT THE BALLOON DID NOT DEFLATE. THE PHYSICIAN WAS ABLE TO PULL THE INFLATED BALLOON INTO THE GUIDE CATHETER WITH RESISTANCE AND THE DEVICES WERE REMOVED AS A SINGLE UNIT. THE RIGHT FEMORAL WAS ACCESSED AND A XIENCE XPEDITION STENT DELIVERY SYSTEM WAS ADVANCED AND THE STENT WAS DEPLOYED SUCCESSFULLY AT THE TARGET SITE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. REPORTEDLY, THE BALLOON WAS NOT SUBMERGED IN HEPARINIZED SALINE PRIOR TO USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309632 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30415G1

    Patients

    Seq Age Sex Outcome Treatment
    1