BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERGARD WOVEN VASCULAR GRAFT

    MDR report key: 1935520 · Received December 1, 2010

    Report

    Report Number
    1640201-2010-00032
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    August 28, 2010
    Report Date
    November 2, 2010
    Manufacturer
    INTERVASCULAR
    Product Code
    DSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: ALL INFO CONTAINED IN THIS REPORT WAS PROVIDED BY THE MFR. NO FACILITY NUMBER HAS BEEN ASSIGNED TO THIS REPORT. EVALUATION SUMMARY: METHOD: THE GRAFT IDENTIFIED AS IGW0018-15, SERIAL NUMBER (B)(4), LOT NUMBER 09D09 WAS RETURNED TO THE MANUFACTURER ON (B)(4) 2010. THE INSPECTION OF THE RETURNED PRODUCT WAS PERFORMED AND THE PRODUCT WAS CONFIRMED TO BE IGW0030-30 VASCULAR GRAFT AND NOT IGW0018-15 AS LABELED. RESULTS: A REVIEW OF THE DEVICE HISTORY RECORDS AND QUALITY RECORDS INDICATED THAT AN INVERSION COULD HAVE OCCURRED AT THE PRIMARY PACKAGING STEP WITH ALL THE IGW0030-30 PACKAGED THE SAME DAY AS THE INVOLVED IGW0018-15. THIS ASSUMPTION LEADS TO CONSIDER NINE (9) PRODUCTS IGW0030-30 AS POTENTIALLY AFFECTED BY A PRODUCT MISLABELING. OUR RECORDS INDICATED THAT THE NINE POTENTIALLY AFFECTED PRODUCTS IGW0030-30 WERE SHIPPED IN THREE DIFFERENT COUNTRIES: ONE IN (B)(4), FOUR IN (B)(4) AND FOUR IN (B)(4). PLEASE NOTE THAT NONE OF POTENTIAL INVOLVED PRODUCT WAS LOCATED IN THE U.S.A. THE PRODUCT IGW0030-30 (SERIAL NUMBER 40115771 SHIPPED IN (B)(4)) WAS ALREADY CONFIRMED AS IMPLANTED. AS A RESULT OF THE INVESTIGATION, INTERVASCULAR HAS INITIATED A VOLUNTARY RECALL FOR THE 8 REMAINING PRODUCTS LOCATED: IN (B)(4) (SERIAL NUMBERS: (B)(4), (B)(4), (B)(4) AND (B)(4)); IN (B)(4) (SERIAL NUMBERS: (B)(4), (B)(4), (B)(4) AND (B)(4)). CONCLUSIONS: THE INVESTIGATION INDICATED THAT THE MISLABELING WAS DUE TO A HUMAN ERROR. PLEASE NOTE THAT THESE MISLABELED PROSTHESES WERE MANUFACTURED IN (B)(4) 2009 AND SHIPPED IN (B)(4) 2009, PRIOR TO THE IMPLEMENTATION OF A CORRECTIVE ACTION PLAN IN (B)(4) 2010 RELATED TO SIMILAR EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERGARD IGW0030-30 WAS FOUND IN A BOX LABELED AS AN INTERGARD IGW0018-15, SERIAL NUMBER (B)(4), LOT 09D09. THERE WAS NO PT INJURY AS THE DEVICE WAS NOT IMPLANTED. THE INVOLVED PRODUCT WAS RETURNED BY THE INSTITUTION TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERGARD WOVEN VASCULAR GRAFT DSY INTERVASCULAR IGW0018-15 09D09

    Patients

    Seq Age Sex Outcome Treatment
    1