BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 3121735 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03304
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE COYOTE ES CATHETER WAS RECEIVED INSIDE A COYOTE ES SHELF BOX THAT MATCHED THE INFORMATION ON THE DEVICE. THE TIP WAS DAMAGED. THE INNER SHAFT WAS KINKED 1MM FROM THE DISTAL EDGE OF THE MARKERBAND. THE DEVICE WAS INFLATED TO RATED BURST PRESSURE (RBP) WITH AN INFLATION DEVICE FILLED WITH WATER. THE DEVICE MAINTAINED RBP WITH NO INDICATION OF ANY LEAKS OR OTHER IRREGULARITIES. AFTER CONFIRMING THE DEVICE MAINTAINED RBP, THE DEVICE WAS DEFLATED BY APPLYING NEGATIVE PRESSURE WITH THE INFLATION DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2013-03303. IT WAS REPORTED THAT DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA LEFT INGUINAL REGION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT POSTERIOR TIBIAL ARTERY. AFTER A NON-BSC GUIDEWIRE WAS CROSSED TO THE LESION. A 1.5MM X 20MM X 142CM COYOTE ES BALLOON CATHETER WAS USED FOR DILATATION OF THE LESION AND THE BALLOON RUPTURED AT 10 ATM ON THE FIRST INFLATION. THEY REPLACED IT WITH A 2MM X 20MM X 143CM COYOTE ES AND THE BALLOON ALSO RUPTURED AT 14 ATM ON THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2013-03303. IT WAS REPORTED THAT DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA LEFT INGUINAL REGION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT POSTERIOR TIBIAL ARTERY. AFTER A NON-BSC GUIDEWIRE WAS CROSSED TO THE LESION. A 1.5MM X 20MM X 142CM COYOTE ES BALLOON CATHETER WAS USED FOR DILATATION OF THE LESION AND THE BALLOON RUPTURED AT 10 ATM ON THE FIRST INFLATION. THEY REPLACED IT WITH A 2MM X 20MM X 143CM COYOTE ES AND THE BALLOON ALSO RUPTURED AT 14 ATM ON THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223751 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134152010 15346649

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: CRUISE| INTRODUCER SHEATH: TERUMO 6F