BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1220250 · Received October 31, 2008

    Report

    Report Number
    2522801-2008-00040
    Event Type
    Other
    Date Received
    October 31, 2008
    Date of Event
    July 1, 2008
    Report Date
    October 30, 2008
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT IS ESTIMATED. A MODEL NUMBER AND LOT NUMBER WERE NOT PROVIDED. HOWEVER, THE PRODUCT INVOLVED WITH THIS INCIDENT WAS REPORTED AS SYNTHETIC ABSORBABLE QUILL SRS. THE 510(K) INFO FOR ALL QUILL SRS PDO PRODUCTS IS AS FOLLOWS: K051609: USP SIZE 2, 0, AND 2-0, K071989: USP SIZE 3-0 AND 4-0, K080680: USP SIZE 3-0 HIGH DENSITY, K080985: USP SIZE 4-0 HIGH DENSITY. ONE SMALL PIECE OF QUILL SRS SUTURE WAS RETURNED. THE PIECE OF SUTURE MEASURES APPROX .25 INCHES IN LENGTH. THE COLOR OF THE SUTURE APPEARS CLEAR TO MILKY-WHITE. UNDER MAGNIFICATION, THE END POINTS OF THE SUTURE APPEAR JAGGED AND BARBS ARE PRESENT ON THE BODY OF THE SAMPLE. CLOSER EXAMINATION OF THE SAMPLE REVEALED THAT THE SUTURE APPEARS DEFORMED AND THE BARBS LOOK SLIGHTLY ROUNDED, POSSIBLY INDICATING THAT IT HAD STARTED TO ABSORB. NO PART/LOT INFO WAS MADE AVAILABLE WITH THE COMPLAINT AND THE EXACT IDENTITY OF THE DEVICE INVOLVED WITH THE INCIDENT CANNOT BE ASCERTAINED FROM THIS SAMPLE ALONE. BASED ON THE EVIDENCE AVAILABLE AT THE TIME OF THIS EVAL, IT APPEARS THAT A QUILL SRS SYNTHETIC ABSORBABLE SUTURE WAS USED DURING THE PT'S BREAST PROCEDURE. MOREOVER, THE ONLY QUILL SRS SYNTHETIC ABSORBABLE SUTURE AVAILABLE AT THE TIME OF THE PT'S BREAST PROCEDURE IN (B) (6) 2008 WAS PDO. MONODERM, THE ONLY OTHER QUILL SRS SYNTHETIC ABSORBABLE SUTURE MARKETED BY ANGIOTECH, DID NOT LAUNCH UNTIL (B) (6) 2008. THE CIRCUMSTANCES SURROUNDING THIS COMPLAINT MAKE IT DIFFICULT TO DRAW ANY DEFINITIVE CONCLUSIONS. HOWEVER, THE EVIDENCE CURRENTLY AVAILABLE DOES INDICATE THAT THE DEVICE USED DURING THE PT'S BREAST PROCEDURE WAS QUILL SRS PDO SYNTHETIC ABSORBABLE SUTURE. SUPERFICIAL PLACEMENT OF A PDO SUTURE CAN LEAD TO IRRITATION IN SOME PTS; ALTHOUGH, NO DEFINITIVE CONCLUSIONS REGARDING THE PT'S ADVERSE REACTION TO THE SUTURE CAN BE DRAWN. (B) (4).

    Description of Event or Problem · 1

    THE PT INITIALLY REPORTED THIS EVENT. FOLLOW-UP INFO WAS OBTAINED FROM THE PT AND FROM THE DOCTOR'S OFFICE THAT PERFORMED THE PROCEDURE. THE PT UNDERWENT A BILATERAL BREAST REDUCTION IN (B) (6) 2008. SIX (6) WEEKS POST SURGERY, THE PT BEGAN TO EXPERIENCE SUTURE SPITTING ON HER LEFT BREAST. THE PT WAS GIVEN A COURSE OF ORAL ANTIBIOTICS (Z-PAC) AND SILVADENE TOPICAL OINTMENT. A CULTURE AND SENSITIVITIES TEST WAS NOT PERFORMED. FIVE (5) MONTHS POST SURGERY, THE PT CONTINUES TO HAVE SPITTING, REDNESS AND IRRITATION. THE PT WILL NEED A SCAR REVISION ON HER LEFT BREAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS BARBED SUTURE WITH NEEDLE NEW SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE MADE AVAILABLE