BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS MULTI-LINK OTW ULTRA CORONARY STENT SYSTEM

    MDR report key: 3000458 · Received March 12, 2013

    Report

    Report Number
    2024168-2013-01419
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 1, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE APPEARED TO HAVE BEEN PREPARED FOR USE, AND A TORN TIP WAS NOTED. THERE WAS NO COMPLAINT AGAINST THIS DEVICE THEREFORE THERE ARE NO ISSUES TO CONFIRM. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE OBSERVED TORN TIP. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING, THE ULTRA STENT WAS REMOVED FROM THE BOX AND WHEN THE LABEL WAS SCANNED, IT WAS NOTED BY THE STAFF THAT THE DEVICE WAS EXPIRED. THE UNOPENED DEVICE WAS PUT BACK INTO THE OUTER BOX AND WAS PUT INTO A BIOHAZARD BAG AS THERE WAS BLOOD ON THE BOX FROM HANDLING BY THE STAFF. THERE IS NO COMPLAINT AGAINST THIS DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS NOTED A SMALL TEAR IN THE DISTAL END OF THE STENT DELIVERY SYSTEM CATHETER TIP. THE MATERIAL WAS STRETCHED AT THE TEAR. IT COULD NOT BE CONFIRMED WHETHER OR NOT THE DEVICE WAS ADVANCED ONTO A GUIDE WIRE. HOWEVER, IT WAS CONFIRMED THAT THE DEVICE WAS NOT ADVANCED INTO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103684 ACS MULTI-LINK OTW ULTRA CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 0111641

    Patients

    Seq Age Sex Outcome Treatment
    1