BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI PROWATER PTCA GUIDE WIRE

    MDR report key: 1902001 · Received November 12, 2010

    Report

    Report Number
    3003775027-2010-00032
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    ABBOTT VASCULAR - CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K022762
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVAL. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFO.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVESTIGATION COULD NOT BE CONDUCTED BECAUSE IT WAS NOT RETURNED, HOWEVER, WE PRESUME AND CONSIDER FROM THE PROVIDED INFORMATION THAT THE GUIDE WIRE TIP WAS TRAPPED BY THE STENT THAT WAS IMPLANTED IN THE MID OF THE RIGHT CORONARY ARTERY (RCA), AND THE GUIDE WIRE WAS BROKEN DUE TO THE PULL-BACK FORCE EXCEEDING THE PRODUCT DESIGN LIMIT WHEN IT WAS REMOVED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE IN AN UNK CORONARY ARTERY, AFTER FOUR PROWATER GUIDE WIRES WERE USED SUCCESSFULLY AND A 5TH PROWATER WAS REMOVED FROM THE BODY, IT WAS NOTICED THAT THE CORE WAS UNRAVELLED AND LESS THAN 2 MM OF THE TIP OF THE GUIDE WIRE WAS MISSING. THE TIP OF THE GUIDE WIRE REMAINS IN THE ANATOMY. IT'S UNK IF ANY RESISTANCE WAS FELT DURING REMOVAL, HOWEVER, CATH LAB STAFF SURMISED THE TIP MAY HAVE CAUGHT ON AN UNK STENT STRUT DURING REMOVAL, DAMAGING THE GUIDE WIRE. THE PT WAS ASYMPTOMATIC. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED. THE DEVICE IS MANUFACTURED BY ASAHI INTECC CO LTD MEDICAL DIVISION; HOWEVER, ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH ADDITIONAL INFORMATION WAS RECEIVED: THE TARGET LESIONS WERE IN THE MID AND DISTAL RIGHT CORONARY ARTERY (RCA). DURING THIS PROCEDURE, AN UNKNOWN STENT WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA). THE PROWATER GUIDE WIRE WAS ADVANCED THROUGH THE STENT, AND ANOTHER STENT WAS IMPLANTED IN THE DISTAL RCA LESION AND THE GUIDE WIRE WAS REMOVED. THERE WAS NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, (B)(4) DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI PROWATER PTCA GUIDE WIRE GUIDE WIRE DQX ABBOTT VASCULAR - CARDIAC THERAPIES NA 091121A251

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GUIDE WIRE: ASAHI PROWATER (X4)