BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL HEMOSTATIC MATRIX

    MDR report key: 1811752 · Received August 23, 2010

    Report

    Report Number
    2954761-2010-00032
    Event Type
    Injury
    Date Received
    August 23, 2010
    Date of Event
    April 23, 2010
    Report Date
    April 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    LMF
    PMA / PMN Number
    P990009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE ATTEMPTS WERE MADE BY BAXTER TO RETRAIN THE SURGEON REGARDING APPROPRIATE PRODUCT APPLICATION AND USAGE WITH NO RESPONSE RECEIVED. IT WAS IDENTIFIED THAT A BAXTER SALES REPRESENTATIVE HAD PREVIOUSLY DISCUSSED THE IMPORTANCE OF IRRIGATING AWAY EXCESS PRODUCT WITH THE SURGEON.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: THE CLINICAL INFORMATION RECEIVED CONFIRMS THAT 5ML OF FLOSEAL HAVE BEEN APPLIED IN THE ABSENCE OF BLEEDING, AND EXCESS PRODUCT HAS NOT BEEN IRRIGATED, ON THE GROUNDS OF ENDOMETRIOSIS LAPAROSCOPIC SURGERY, AND IN THE ABSENCE OF AN INADVERTENT BOWEL PERFORATION, SUGGESTS THAT FLOSEAL MAY HAVE CONTRIBUTED TO THE OCCURRENCE OF THE DIFFUSE PERITONEAL IRRITATION. SURGEON'S DOCUMENTED RETRAINING WITH SPECIAL EMPHASIS ON NOT USING FLOSEAL FOR PROPHYLACTIC HAEMOSTATIC PURPOSES, OR EVEN FOR ADHESION PREVENTION, AS WELL AS THE NEED TO IRRIGATE PRODUCT EXCESS, IS RECOMMENDED. (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE RETRAINING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTCA TREATMENT PROCEDURE, A BALLOON RUPTURE AND VESSEL PERFORATION OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 80% INSTENT RESTENOSED (ISR) TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). ANOTHER MANUFACTURER'S GUIDE CATHETER AND GUIDE WIRE WERE ADVANCED TO THE TARGET LOCATION AND A 2.5-12MM FLEXTOME CUTTING BALLOON WAS SELECTED BUT WAS UNABLE TO CROSS THE LESION. THE CUTTING BALLOON WAS REMOVED AND A 12MM X 2.50MM APEX MONORAIL BALLOON CATHETER WAS ADVANCED AND INFLATED TWO TIMES. THE FIRST INFLATION WAS TO 12 ATMS FOR 60 SECONDS. AFTER THE FIRST INFLATION THE PATIENT CONTINUED TO COMPLAIN OF SEVERE BACK PAIN. ON THE SECOND INFLATION AT 14 ATMS FOR 45 SECONDS A BALLOON RUPTURE AND SMALL VESSEL PERFORATION OCCURRED. THE BALLOON CATHETER WAS REMOVED AND THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE RESIDUAL STENOSIS WAS 50%. AFTER THE PROCEDURE PATIENT'S PAIN PERSISTED DESPITE FOUR DOSES OF PAIN MEDICATION. PHYSICIAN DECIDED TO ALLOW VESSEL PERFORATION TO HEAL WITHOUT ANY FURTHER INTERVENTION. THE PATIENT WAS RELEASED 24 HOURS LATER AND INSTRUCTED TO FOLLOW UP WITH PERSONAL CARDIOLOGIST.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT HE NO LONGER USES FLOSEAL BECAUSE IN THE PAST 18 MONTHS HE HAS HAD 3-4 CASES WHERE AFTER A ROBOTIC ENDOMETRIOSIS, WITHIN 24-48 HOURS POST-OP, THE PATIENTS GOT A PERITONITIS INFECTION. NO ONE DIED. ALL HAVE RECOVERED. HE DID NOT OFFER ANY PATIENT INFORMATION TO THE SALES REP. BAXTER INITIALLY DEEMED THE CASE NOT REPORTABLE. ADDITIONAL INFORMATION RECEIVED ON 12-AUG-2010: THE REPORTER CLARIFIED THAT ONLY TWO PATIENTS WERE INVOLVED. PATIENT INITIALS (B)(6): FIVE ML OF FLOSEAL WAS APPLIED DURING THE SURGERY, WHICH WAS PERFORMED IN (B)(6) 2009. A LAPAROSCOPIC APPLICATOR WAS USED; HOWEVER, IT IS UNKNOWN IF THE APPLICATOR WAS RE-USABLE OR DISPOSABLE. THE SURGEON APPROXIMATED FLOSEAL FOR TWO MINUTES AFTER APPLICATION. FLOSEAL WAS NOT APPLIED IN THE PRESENCE OF BLEEDING, AND EXCESS FLOSEAL WAS NOT IRRIGATED AFTER HEMOSTASIS WAS ACHIEVED. A DIAGNOSTIC LAPAROSCOPY WAS NOT PERFORMED. LABORATORY FINDINGS FOUND DIFFUSE-PERITONEAL IRRITATION, BUT NO SIGNS OF BOWEL PERFORATION. THERAPY PROVIDED TO THE PATIENT FOR PERITONITIS INCLUDED A LAPARATOMY, IRRIGATION, AND ANTIBIOTICS. THE EVENT INVOLVING PATIENT INITIALS LD IS BEING ASSESSED SEPARATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOSEAL HEMOSTATIC MATRIX AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF BAXTER HEALTHCARE - HAYWARD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other