BEUDAMED
    FDA Adverse Event Death Summary report: N

    BAINHA INTRODUTORA SPEED CROSS MSB (MSB SPEED CROSS INTRODUCER SHEATH)

    MDR report key: 7061113 · Received November 27, 2017

    Report

    Report Number
    1035166-2017-00096
    Event Type
    Death
    Date Received
    November 27, 2017
    Date of Event
    August 3, 2017
    Report Date
    May 18, 2018
    Manufacturer
    MSB MEDICAL SYSTEMS DO BRASIL
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING SECTION WAS CORRECTED IN FOLLOW-UP # 2: THE CUSTOMER PROVIDED THE CORRECT DATE OF PATIENT'S DEATH AS (B)(6) 2017.

    Additional Manufacturer Narrative · 1

    THE EVALUATION PREVIOUSLY SUBMITTED WAS CONDUCTED ON 27-NOV-2017, AND REFERENCES THE RETURNED (B)(4) UNUSED SAMPLES FROM THE REPORTER THAT HAD THE SAME LOT NUMBER. UPON REVIEW OF THE COMPLAINT RECORD INFORMATION, IT WAS DISCOVERED THAT THE ACTUAL DEVICE USED IN THE PROCEDURE WAS RETURNED ON 07-MARCH-2018, THIS WAS INADVERTENTLY OMITTED IN ERROR. THE DEVICE WAS USED IN A PROCEDURE FOR ABLATION OF ATRIAL FIBRILLATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED AND FOUND SIX (6) UNITS FAILED THE LEAK TEST DURING MANUFACTURING AND WERE SCRAPPED. THE SHEATHS RELEASED TO INVENTORY PASSED ALL IN-PROCESS AND QA FINAL INSPECTION BEFORE SHIPPING TO THE CUSTOMER INCLUDING VISUAL, DIMENSIONAL AND LEAK TESTING. A COMPLAINT REVIEW OF THE REPORTED LOT FOUND NO ADDITIONAL REPORTS FOR THIS FAILURE MODE. ONE 10F BREEZEWAY SHEATH WAS RETURNED WITH THE DILATOR. BLOOD WAS FOUND ON AND INSIDE THE SHEATH AND DILATOR. THERE WERE NO OTHER ACCESSORIES RETURNED. THE HEMOSTASIS VALVE WAS DETACHED FROM THE SHEATH. UPON EVALUATION OF THE RETURNED SHEATH AND HEMOSTASIS VALVE, IT WAS FOUND THAT THE VALVE WAS COMPLETELY DETACHED FROM THE SHEATH AND THERE IS A PUNCTURE HOLE IN THE HEMOSTASIS VALVE THAT IS CONSIDERABLY OFF CENTER FROM THE HELICAL CUTS AT THE CENTER OF THE VALVE. THIS INDICATES THAT THE DILATOR WAS NOT INSERTED THROUGH THE CENTER OF THE VALVE. THE HELICAL CUTS IN THE CENTER OF THE VALVE LOOK NORMAL AND ARE NOT FATIGUED IN ANY WAY. THERE WERE NO MANUFACTURING DEFECTS DETECTED WITH THE VALVE, SHEATH OR DILATOR. RETURNED DEVICE ANALYSIS REVEALS THE 10F BREEZEWAY VALVE, SHEATH AND DILATOR ARE WITHIN MANUFACTURING SPECIFICATIONS. NO MANUFACTURING DEFECTS WERE FOUND ON THE RETURNED DEVICE. THE COMBINATION OF THE USER INSERTING THE DILATOR SIGNIFICANTLY OFF CENTER AND PULLING THE DILATOR OUT TOO QUICKLY COULD RESULT IN AN AIR EMBOLISM. PER PROCEDURE INTRODUCER SHEATH, ADELANTE BREEZEWAY, IN-PROCESS AND FINAL INSPECTION, VISUAL INSPECTION, WITH THE NAKED EYE, VERIFY THE SHAPE AND FORM OF HUB AREA. VERIFY THAT THE HUB IS FREE OF DAMAGES AT THE SEAL, BONDED SEAL CAP, HUB, STOPCOCK AND SIDEPORT TUBING. LEAK TESTING IS PERFORMED ON 100% OF THE SHEATHS BY QA AS REQUIRED IN NON-PEELABLE SHEATH FINAL ASSEMBLY PROCEDURE. THIS PRODUCT IS SUPPLIED BULK NON-STERILE WITHOUT AN IFU (INSTRUCTIONS FOR USE) TO THE CUSTOMER FOR FURTHER PROCESSING.

    Additional Manufacturer Narrative · 1

    CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. THIS INITIAL MDR IS BEING SUBMITTED TO MEET OUR REQUIREMENTS OF REPORTING. A FOLLOW-UP WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE. (B)(4) RECEIVED REPORT NUMBER MW5072774 ON OCTOBER 27, 2017 FROM THE FDA. (B)(4) IS THE SUPPLIER OF THIS BULK NON STERILE DEVICE SOLD TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    SECTIONS WERE UPDATED IN FOLLOW-UP # 1: THE SHEATH THAT WAS USED IN THIS PROCEDURE WAS NOT RETURNED FROM THE CUSTOMER/MANUFACTURER, SO IT WAS NOT POSSIBLE TO PERFORM A FULL COMPREHENSIVE EVALUATION. THE CUSTOMER/MANUFACTURER PROVIDED IMAGES SHOWING THAT THERE IS A PUNCTURE HOLE IN THE VALVE CONSIDERABLY OFF CENTER FROM THE HELICAL CUTS AT THE CENTER OF THE VALVE. TWENTY THREE (23) UNUSED UNITS FROM THE SAME LOT NUMBER C1-10478 WERE RETURNED FOR ANALYSIS. THE 23 UNITS WERE VISUALLY INSPECTED TO ENSURE THAT THE CAP WAS CORRECTLY ASSEMBLED AND HEMOSTASIS VALVE WAS PROPERLY SEATED. NO VISUAL DEFECTS WE FOUND ON THE RETURNED DEVICES. ALL 23 UNITS RETURNED WERE LEAK AND VACUUM TESTED PER PROCEDURE TO ENSURE THERE IS NO EXISTING ISSUE. ALL 23 UNITS PASSED LEAK AND VACUUM TESTING. FOUR (4) OF THE RETURNED SHEATHS WERE USED FOR ADDITIONAL DESTRUCTIVE TESTING. TWO (2) OF THESE SHEATHS HAD THE DILATOR FULLY INSERTED INTO THE CENTER OF THE VALVE AND THEN REMOVED. THE REMAINING TWO (2) TESTED SHEATHS HAD THE DILATOR FULLY INSERTED AT THE EDGE OF THE HUB CAP, PURPOSELY CREATING A NEW HOLE OFF CENTER OF THE HELICAL CUTS AND THEN REMOVED. ALL FOUR (4) SHEATHS WERE THEN RETESTED UNDER THE SAME LEAK AND VACUUM TEST AND STILL PASSED. IN ORDER TO CREATE A PUNCTURE IN THE SEAL AS CONSIDERABLY OFF CENTER AS IDENTIFIED IN THE IMAGES, THE DILATOR HAD TO BE INTRODUCED TO THE SEAL AT ABOUT A 45° ANGLE AND UNDERNEATH THE CAP. EVEN WITH THE PUNCTURE CONSIDERABLY OFF CENTER, THE SEAL DID NOT PROLAPSE UNLESS THE DILATOR WAS QUICKLY WITHDRAWN FROM THE SHEATH. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NO ADDITIONAL COMPLAINTS FOR THIS FAILURE MODE. THE REASON FOR RETURN CANNOT BE CONFIRMED REGARDING THE SHEATHS THAT WERE RETURNED FOR EVALUATION. NO MANUFACTURING DEFECTS WERE FOUND ON THE RETURNED DEVICES. THE COMBINATION OF THE USER INSERTING THE DILATOR SIGNIFICANTLY OFF CENTER AND PULLING THE DILATOR OUT TOO QUICKLY COULD RESULT IN AN AIR EMBOLISM. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. PER QA PROCEDURE INTRODUCER SHEATH, ADELANTE BREEZEWAY, IN-PROCESS AND FINAL INSPECTION: VISUAL INSPECTION: WITH THE NAKED EYE, VERIFY THE SHAPE AND FORM OF HUB AREA. VERIFY THAT THE HUB IS FREE OF DAMAGES AT THE SEAL, BONDED SEAL CAP, HUB, STOPCOCK AND SIDEPORT TUBING. LEAK TESTING IS PERFORMED ON 100% OF THE SHEATHS BY QA. THIS PRODUCT IS SUPPLIED BULK NON-STERILE WITHOUT THE INSTRUCTIONS FOR USE (IFU) TO THE CUSTOMER/MANUFACTURER FOR FURTHER PROCESSING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL, DIAGNOSED WITH ATRIAL FIBRILLATION, WHERE HE WAS INTERNED IN ORDER TO UNDERGO AN ABLATION PROCEDURE FOR THE ATRIAL FIBRILLATION. DURING THE PROCEDURE, HE PRESENTED AN INCIDENT WITH THE CONSEQUENCE OF A CEREBROVASCULAR ACCIDENT (STROKE) DUE TO AIR EMBOLISM. DURING THE PREPARATIONS FOR THE ABLATION PROCEDURE, THE FOLLOWING BELOW OCCURRED: BEFORE DOING THE VENOUS ACCESS IN THE RIGHT FEMORAL VEIN, THE INTRODUCERS (SHORT AND LONG SHEATHS) WERE PREPARED BY INTRODUCING SALINE SOLUTION 0.9% IN THEIR LUMEN (INSIDE THE SHEATH AS WELL AS THE DILATOR). THE PATIENT WAS SEDATED WITH ANESTHESIA. THE INITIAL ACCESSES BEING PERFORMED, THERE WERE TWO VENOUS PUNCTURES IN THE RIGHT FEMORAL VEIN. AFTER HAVING PLACED THE DIAGNOSTIC DECAPOLAR CATHETER IN THE CORONARY SINUS AND INSERTED THE SPEED CROSS SHEATH UP TO THE SUPERIOR VENA CAVA, THE GUIDE-WIRE WAS REMOVED FROM THE SHEATH, THE TRANSSEPTAL PUNCTURE NEEDLE WAS INTRODUCED WHICH WENT AS FAR AS THE DILATOR LIMIT (IT DID NOT GO FURTHER THAN THE DILATOR), THE SYSTEM WAS PULLED, SHEATH AND NEEDLE IN APPROPRIATE POSITION UNTIL THE SECOND DROP, EXPOSING THE TIP OF THE NEEDLE AND PROCEEDING TO DO THE TRANSSEPTAL PUNCTURE. ONCE THE TIP OF THE NEEDLE WAS INSIDE OF THE LEFT ATRIUM, BLOOD WAS ASPIRATED THROUGH THE DILATOR TIP TO MAKE SURE THAT IT WAS ARTERIAL BLOOD AND WITH THE SAME SYRINGE (WHICH ALREADY HAD CONTRAST MEDIA IN IT), A SMALL INJECTION OF CONTRAST WAS MADE, CONFIRMING THAT THE TIP WAS INSIDE THE LEFT ATRIUM. IMMEDIATELY AFTER, THE WHOLE SYSTEM WAS INTRODUCED INTO THE LEFT ATRIUM, TAKING CARE TO PULL BACK THE TIP OF THE NEEDLE INSIDE THE DILATOR. THIS WHOLE PROCESS WAS PERFORMED IN THE PATIENT WITHOUT ANY INCIDENT. FOLLOWING THIS, THE DILATOR WAS REMOVED FROM THE SHEATH, TOGETHER WITH THE PUNCTURE NEEDLE, THIS WITHDRAWAL WAS PERFORMED WITH MUCH CAUTION SO AS TO KEEP THE SHEATH INSIDE THE LEFT ATRIUM AND NOT LOSE THE PUNCTURE SITE WHICH REQUIRES RADIOLOGICAL MONITORING OF THE WITHDRAWAL. THE PROBLEM WITH THE SHEATH APPEARED IN THE PATIENT IN THIS EXACT MOMENT. AT THE END OF THE DILATOR REMOVAL, THE SEALING VALVE OF THE SHEATH SLIPPED OUT, ALLOWING AIR TO ENTER THE SHEATH AND TEN ATRIAL SYSTOLES OCCURRED BEFORE REINTRODUCING THE DILATOR INTO THE VALVE SEAL. THE DOCTOR PROCEEDED TO EXCHANGE THE SHEATH, BUT IT WAS NOTED THAT THE PATIENT ALTHOUGH SEDATED WAS HAVING INVOLUNTARY MOVEMENTS WITH THE LOWER LEFT LIMB. SEDATION WAS STOPPED AND THE PATIENT DID NOT WAKE UP OR MOVE. THE PROCEDURE WAS SUSPENDED. IMMEDIATELY AFTER THE INCIDENT OCCURRED, THE PATIENT WAS TAKEN TO RADIOLOGY TO PERFORM A CEREBRAL ANGIOTOMOGRAPHY EXAM (UNDER AN HOUR), THAT CONFIRMED AIR IN THE CEREBRAL VENOUS SYSTEM (IT HAD ALREADY PASSED FROM THE ARTERIAL SYSTEM TO THE VENOUS SYSTEM), CONFIRMING THE DIAGNOSIS OF AIR EMBOLISM. HE WAS TAKEN TO INTENSIVE CARE, WHERE HE WAS INTUBATED FOR ASSISTED PULMONARY VENTILATION AND PROVIDED ALL ASSISTANCE BY THE MULTI-PROFESSIONAL TEAM ON HAND. HE HAS STABLE HEMODYNAMICS (BLOOD CIRCULATION), BUT IS IN COMA GLASGOW 10, WHICH IS DECREASING (WORSENING). HE IS STILL IN INTENSIVE CARE, A NEW CEREBRAL ANGIOTOMOGRAPHY EXAM WAS PERFORMED, SHOWING A MAJOR CEREBRAL INJURY. IT WAS REPORTED THE DEVICE WAS WITH THE DOCTOR AT THE HOSPITAL. ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 27, 2017, THE PATIENT IS AT HOME RECEIVING MEDICAL CARE THROUGH THE HOMECARE SERVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2018 THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THEY RECEIVED AN E-MAIL FROM THE DOCTOR ON (B)(6) 2018, INFORMED THAT PATIENT WAS DEATH. WE DO NOT HAVE THE REASON FOR THE DEATH OF THE PATIENT BECAUSE IT OCCURRED OUT OF OUR REACH, WHICH I KNOW: HE WAS IN A COMA WITHOUT NEUROLOGICAL IMPROVEMENTS IN HOME CARE. IN THE SAME EMAIL, DOCTOR INFORMED THAT WILL NOW RETURN THE SHEATH FOR A DETAILED ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837689 BAINHA INTRODUTORA SPEED CROSS MSB (MSB SPEED CROSS INTRODUCER SHEATH) BAINHA INTRODUTORA SPEED CROSS MSB (MSB SPEED CROSS INTRODUCER SHEATH) DYB MSB MEDICAL SYSTEMS DO BRASIL SPEED CROSS 58155 000109I10

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| H| L| R| S