BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SI BRITE TIP

    MDR report key: 3072988 · Received April 23, 2013

    Report

    Report Number
    9616099-2013-00246
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 9, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DYB
    PMA / PMN Number
    K984500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THEREFORE, A TOURNIQUET WAS APPLIED TO THE ACCESS SITE AND INFUSION SOLUTION WAS ADMINISTERED. THEN, THE PATIENT'S BLOOD PRESSURE WAS RECOVERED TO THE NORMAL PRESSURE. THE APPLIED TOURNIQUET AND INFUSION SOLUTION (TOTAL APPROXIMATELY 1.5L) WERE CONTINUED FOR A NIGHT. THE PATIENT'S HEMOGLOBIN VALUE WAS REDUCED FROM 11.4G/DL (BEFORE THE PROCEDURE) TO 9.9G/DL DUE TO BLEEDING. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AS SCHEDULED THE NEXT DAY SINCE HER CONDITION WAS STABLE AND SHE WANTED TO DISCHARGE HERSELF. PHYSICIAN'S COMMENT: BECAUSE THE BLEEDING WAS NOT OBSERVED FROM BODY SURFACE, THE BLEEDING AT ACCESS SITE COULD NOT BE NOTICED UNTIL THE COMPUTER TOMOGRAPHY WAS CONDUCTED. THE BLEEDING FLOWED INTO THE LOWER ABDOMEN, BUT SWELLING WAS NOT NOTICED BECAUSE OF HER OBESITY. HER ESTIMATED AMOUNT OF BLEEDING WAS APPROXIMATELY 1L. SUSPICIOUS CAUSE OF THE BLEEDING WAS BLOOD EXUDED FROM A SLIGHT GAP BETWEEN THE PLUG AND THE VESSEL. BEFORE USE OF THE EXOSEAL, THE COMMON FEMORAL ARTERY WAS NOT VERIFIED FOR ITS SUITABILITY FOR ARTERIOTOMY CLOSURE WITH THE EXOSEAL. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2013-00246 AND 9616099-2013-00247.

    Additional Manufacturer Narrative · 1

    TWO HOURS AFTER USE OF AN EXOSEAL (7F) DEVICE FOR VASCULAR CLOSURE, THE PATIENT'S BLOOD PRESSURE DROPPED SLIGHTLY. A CT SCAN CONFIRMED A SUBMUSCULAR BLEED (HEMATOMA) THAT WAS TREATED WITH A PRESSURE BANDAGE AND INTRAVENOUS FLUID ADMINISTRATION. THE PATIENT'S BLOOD PRESSURE RETURNED TO NORMAL AND THE PATIENT WAS DISCHARGED THE NEXT DAY. THE PATIENT WAS A (B)(6) FEMALE. THE PATIENT WAS OBESE (BODY WEIGHT NOT AVAILABLE). THE EXOSEAL WAS USED FOR HEMOSTASIS OF THE RIGHT COMMON FEMORAL ARTERY WITH A BRITE TIP CORDIS SHEATH. THERE WAS NO CALCIFICATION OR STENOSIS OBSERVED AT THE ACCESS SITE. THE INTERVENTIONAL PROCEDURE WAS FINISHED SUCCESSFULLY. IT WAS INDICATED THAT THERE WERE NOT MULTIPLE STICK ATTEMPTS MADE BEFORE ARTERIAL ACCESS WAS ACHIEVED. THERE WAS NO PULSATILE BLEEDING OF THE PUNCTURE SITE IMMEDIATELY NOTED UPON REMOVAL OF THE EXOSEAL VCD AND SHEATH. IT IS UNKNOWN IF THE PATIENT WAS ANTICOAGULATED. THE PATIENT KEPT QUIET AT HER BED, AND A PRESSURE BANDAGE WAS APPLIED. APPROXIMATELY 30 MINUTES AFTER THE PROCEDURE THE PATIENT'S BLOOD PRESSURE WAS SLIGHTLY REDUCED AND SHE COMPLAINED OF DISCOMFORT IN THE LOWER ABDOMEN. ECHOCARDIOGRAPHY WAS PERFORMED AND WAS NORMAL. THERE WAS NO BLEEDING FROM THE ACCESS SITE, ON THE BODY SURFACE. THE PHYSICIAN DID NOT TAKE ANY ACTION AND TOOK A WAIT-AND-SEE APPROACH. TWO HOURS POST PROCEDURE, THE PATIENT'S BLOOD PRESSURE WAS REDUCED TO 60 MMHG AND A HEMATOMA WAS OBSERVED AT THE RIGHT COMMON FEMORAL ARTERY (ACCESS SITE). THIS WAS CONFIRMED WITH COMPUTER TOMOGRAPHY (CT). THERE WAS NO BLEEDING OBSERVED ON BODY SURFACE AT THE ACCESS SITE. THEREFORE, A PRESSURE BANDAGE WAS APPLIED TO THE ACCESS SITE AND INFUSION SOLUTION WAS ADMINISTERED. THEN, THE PATIENT'S BLOOD PRESSURE WAS RECOVERED TO THE NORMAL PRESSURE. THE PRESSURE BANDAGE AND INFUSION SOLUTION (TOTAL APPROXIMATELY 1.5L) WERE CONTINUED FOR A NIGHT. THE PATIENT'S HEMOGLOBIN VALUE WAS REDUCED FROM 11.4G/DL (BEFORE THE PROCEDURE) TO 9.9G/DL DUE TO BLEEDING. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AS SCHEDULED THE NEXT DAY SINCE HER CONDITION WAS STABLE AND SHE WANTED TO DISCHARGE HERSELF. THE PHYSICIAN COMMENTED THAT "BECAUSE THE BLEEDING WAS NOT OBSERVED FROM BODY SURFACE, THE BLEEDING AT ACCESS SITE COULD NOT BE NOTICED UNTIL THE COMPUTER TOMOGRAPHY WAS CONDUCTED. THE BLEEDING FLOWED INTO THE LOWER ABDOMEN, BUT SWELLING WAS NOT NOTICED BECAUSE OF HER OBESITY. HER ESTIMATED AMOUNT OF BLEEDING WAS APPROXIMATELY 1L. SUSPICIOUS CAUSE OF THE BLEEDING WAS BLOOD EXUDED FROM A SLIGHT GAP BETWEEN THE PLUG AND THE VESSEL. BEFORE USE OF THE EXOSEAL, THE COMMON FEMORAL ARTERY WAS NOT VERIFIED FOR ITS SUITABILITY FOR ARTERIOTOMY CLOSURE WITH THE EXOSEAL". THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. ACCESS SITE HEMATOMAS ARE A COMMON PROCEDURAL COMPLICATION AND ARE FREQUENTLY RELATED TO STICK TECHNIQUE, ANTICOAGULATION, BLOOD PRESSURE AND/OR DISCOMFORT DURING AND AFTER THE PROCEDURE. ACHIEVING AND MAINTAINING HEMOSTASIS IN OBESE PATIENTS, AFTER WITHDRAWAL OF THE SHEATH, CAN ALSO PROVE CHALLENGING DUE TO EXCESS ADIPOSE TISSUE. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT AND/OR PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE EVENTS ARE RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2013-00246 AND 9616099-2013-00247.

    Description of Event or Problem · 1

    AFTER USE OF AN EXOSEAL (7F) VASCULAR CLOSURE DEVICE THE PATIENT'S BLOOD PRESSURE DROPPED SLIGHTLY. A CT SCAN CONFIRMED A SUBMUSCULAR BLEED (HEMATOMA) THAT WAS TREATED WITH A BLOOD TRANSFUSION. THE PATIENT'S BLOOD PRESSURE RETURNED TO NORMAL AND THE PATIENT WAS DISCHARGED THE NEXT DAY. AS PER THE PHYSICIAN, THE BLOOD EXUDED FROM THE SLIGHT GAP BETWEEN THE PLUG AND THE VESSEL. THE PATIENT WAS A (B)(6) FEMALE. THE PATIENT WAS OBESE (BODY WEIGHT NOT AVAILABLE). THE EXOSEAL WAS USED FOR HEMOSTASIS OF THE RIGHT COMMON FEMORAL ARTERY WITHOUT A PROBLEM. THERE WAS NO CALCIFICATION OR STENOSIS OBSERVED AT THE ACCESS SITE. THE INTERVENTIONAL PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO PULSATILE BLEEDING OF THE PUNCTURE SITE IMMEDIATELY NOTED UPON REMOVAL OF THE EXOSEAL VCD AND SHEATH. IT IS UNKNOWN IF THE PATIENT WAS ANTICOAGULATED. THE PATIENT KEPT QUIET AT HER BED, AND A PRESSURE BANDAGE WAS APPLIED. APPROXIMATELY 30 MINUTES AFTER THE PROCEDURE THE PATIENT'S BLOOD PRESSURE WAS SLIGHTLY REDUCED AND SHE COMPLAINED OF DISCOMFORT IN THE LOWER ABDOMEN. ECHOCARDIOGRAPHY WAS PERFORMED AND WAS NORMAL. THERE WAS NO BLEEDING FROM THE ACCESS SITE, ON THE BODY SURFACE. THE PHYSICIAN DID NOT TAKE ANY ACTION AND TOOK WAIT AND SEE PROCEDURE. TWO HOURS POST PROCEDURE, THE PATIENT'S BLOOD PRESSURE WAS REDUCED TO 60 MMHG AND A HEMATOMA WAS OBSERVED AT THE RIGHT COMMON FEMORAL ARTERY (ACCESS SITE). THIS WAS CONFIRMED WITH COMPUTER TOMOGRAPHY (CT). THERE WAS NO BLEEDING OBSERVED ON BODY SURFACE AT THE ACCESS SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174758 SI BRITE TIP ENDOVASCULAR VASCULAR ACCESS (DYB) DYB CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R EXOSEAL (7F)