BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL KNOTLESS TISSUE CLOSURE DEVICE

    MDR report key: 2278795 · Received September 30, 2011

    Report

    Report Number
    2522801-2011-00021
    Event Type
    Other
    Date Received
    September 30, 2011
    Date of Event
    September 16, 2011
    Report Date
    September 28, 2011
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE AVAILABLE FOR EVALUATION. THEREFORE, NO TESTING CAN BE PERFORMED. ADDITIONAL ITEM REPORTED BY THIS CUSTOMER: 0 PDO; MODEL/CATALOG #: RA-1067Q; LOT #: M614230; EXPIRATION DATE: 12/21/2013; DEVICE MANUFACTURE DATE: 12/2010; 510(K) #: K051609. METHOD: THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. RESULTS/CONCLUSION: THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS AND STERILIZATION RECORDS WERE REVIEWED AND THERE WERE NO CORRESPONDING ISSUES IDENTIFIED DURING THE MANUFACTURING PROCESSES, STERILIZATION PROCESS OR AT FINAL INSPECTION. TO DATE, NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THE REPORTED FINISHED GOOD LOTS. IT'S POSSIBLE THE TECHNIQUE AND PLACEMENT OF THE PDO MATERIAL ATTRIBUTED TO THESE EVENTS. HOWEVER, A DEFINITIVE CONCLUSION CAN NOT BE DRAWN AT THIS TIME. THE SALES REPRESENTATIVE WILL FOLLOW-UP WITH THIS SURGEON AND RESIDENTS TO DISCUSS CURRENT TECHNIQUE AND PLACEMENT OF THIS SIZE/TYPE DEVICE AND PROVIDE INFO THAT CAN BE OBTAINED FROM ANGIOEDUPRO.COM. ANGIOTECH REFERENCE: (B)(4). ITEM # RA-1067Q, QUILL KNOTLESS TISSUE CLOSURE DEVICE, 0 PDO, LOT: M696880, M614230.

    Description of Event or Problem · 1

    THE DATE OF EVENT IS ESTIMATED: AN ANGIOTECH SALES REPRESENTATIVE REPORTED THAT DR (B)(6) HAD FIVE (5) PTS RETURN POST-OPERATIVELY WITH INFLAMMATORY REACTION/ GRANULOMA ALONG THE WOUND EDGES FOLLOWING TOTAL KNEE PROCEDURES WHERE QUILL SIZE 0-PDO WAS USED FOR CLOSURE OF THE INTERMEDIATE LAYERS. FOUR (4) OF THE PTS WERE RETURNED TO THE OPERATING ROOM FOR SCAR REVISION PROCEDURES. THE SURGEON STATED THAT HE FEELS THE RESIDENTS THAT PERFORM THE CLOSURES ARE PLACING THE PDO DEVICES TOO SUPERFICIALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL KNOTLESS TISSUE CLOSURE DEVICE BARBED SUTURE/NEEDLES NEW SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH) RA-1067Q M696880

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention