BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLARICE RX

    MDR report key: 8930530 · Received August 26, 2019

    Report

    Report Number
    9612164-2019-03564
    Event Type
    Malfunction
    Date Received
    August 26, 2019
    Date of Event
    August 13, 2019
    Report Date
    November 6, 2019
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    LOX
    PMA / PMN Number
    703324711
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION TO REGULATORY REPORT (B)(4): PMA / 510(K) # K143480. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS SUMMARY: THE SHEATH AND STYLETTE WERE NOT RETURNED FOR ANALYSIS. KINKS WERE VISIBLE ON THE HYPOTUBE, TACTILE TESTING CONFIRMED KINKS. THERE WAS NO DEFORMATION EVIDENT TO THE DISTAL TIP. THE DISTAL BALLOON MATERIAL APPEARED TO BE BUNCHED ON THE DISTAL TIP. THE BALLOON WAS PARTIALLY INFLATED. THE PROXIMAL BALLOON BOND WAS NECKED. DEFORMATION WAS EVIDENT TO THE DISTAL SHAFT FROM 4.8CM TO 5.2 CM PROXIMAL TO THE DISTAL TIP. IT WAS NOT POSSIBLE TO INFLATE THE BALLOON IN ORDER TO PERFORM DEFLATION TESTING DUE TO THE CONDITION ON THE PROXIMAL BALLOON BOND. THERE WAS NO OTHER DAMAGE EVIDENT TO THE REMAINDER OF THE DEVICE. ADDITIONAL INFORMATION: THE SOLARICE WAS INTENDED FOR PRE-DILATION. THE LESION WAS IN A TYPICAL DISTAL VESSEL. CALCIFICATION WAS ABOUT 30 %. NO DIFFICULTIES WERE ENCOUNTERED WHEN REMOVING THE PROTECTIVE SHEATH OR PACKAGING STYLETTE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO DIFFICULTIES WERE NOTED DURING INFLATION OF THE DEVICE. 14ATM PRESSURE WAS APPLIED. DEFLATION DIFFICULTIES WERE NOTED AFTER THE FIRST INFLATION. THE BALLOON FAILED TO DEFLATE. THE DEVICE WAS REMOVED FORCIBLY. A DIFFERENT BALLOON AND STENT WERE USED FOR THE DISTAL SECTION OF THE ANTERIOR BRANCH. TWO NON-MEDTRONIC STENTS WERE DIRECTLY IMPLANTED. ADDITIONAL BALLOONS WERE NOT USED. THE PATIENT IS ALIVE WITH NO INJURY. ONLY SOLARICE AND A NON-MEDTRONIC WIRE WERE BEING USED. THE PROCEDURE WAS NOT COMPLEX. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE SOLARICE DEVICE IS CONSIDERED TO BE THE SAME AS EUPHORA WITH THE EXCEPTION OF A DIFFERENT BRAND NAME AND MINOR DIFFERENCES IN THE LABELING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A SOLARICE RX PTCA BALLOON CATHETER WAS USED TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. RESISTANCE WAS ENCOUNTERED. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES WERE EXPERIENCED AT THE LESION SITE. THERE WAS A PROBLEM ENCOUNTERED TRYING TO REMOVE THE BALLOON FROM THE VESSEL. THE PATIENT IS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723966 SOLARICE RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC MEXICO 217859787

    Patients

    Seq Age Sex Outcome Treatment
    1