BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 3952676 · Received July 23, 2014

    Report

    Report Number
    2134265-2014-04257
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 27, 2014
    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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. 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: RETURNED PRODUCT CONSISTED OF COYOTE ES BALLOON CATHETER WITH NO OTHER DEVICES. THERE WAS BLOOD IN THE INFLATION LUMEN. THE SHAFT WAS KINKED 74CM FROM THE HUB. MAGNIFIED INSPECTION IDENTIFIED A PINHOLE IN THE BALLOON MATERIAL 1CM FROM THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. MAGNIFIED INSPECTION DID NOT REVEAL ANY DAMAGE OR IRREGULARITIES IN THE PROXIMAL BOND AND MARKERBONDS. INSPECTION OF THE REMAINDER OF THE DEVICE REVEALED NO OTHER DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2MM X 40MM X 145CM COYOTE¿ ES BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. HOWEVER DURING UNSPECIFIED INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2MM X 40MM X 145CM COYOTE¿ ES BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. HOWEVER DURING UNSPECIFIED INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431598 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135204010 16933010

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: CRUISE (ST.JUDE MEDICAL)