BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 4339039 · Received December 17, 2014

    Report

    Report Number
    1058196-2014-00310
    Event Type
    Death
    Date Received
    December 17, 2014
    Date of Event
    November 22, 2014
    Report Date
    February 5, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THEN, THE INITIAL 2.5 X 5 GALAXY COIL WAS USED SINCE IT WAS .012 COIL VS THE .010 STRYKER COIL. IT WAS ADVANCED AND THIS TIME SUCCESSFULLY DEPLOYED AND DETACHED IN THE ANEURYSM. AFTER 4.5 HOURS WORKING ON THIS PATIENT, THE PHYSICIANS DECIDED THAT ONE COIL WAS ALL NEEDED, AND THEY WERE DONE. THEY REMOVED THE ENTERPRISE AND PROWLER SELECT PLUS SUCCESSFULLY AND IT WAS NEVER DEPLOYED AS AN IMPLANT IN THE PATIENT. THEY THEN REMOVED THE OTHER PROWLER AND DID THE FOLLOW UP POST CASE ANGIOGRAMS AND THEY LOOKED VERY GOOD. THE ENVOY DA WAS REMOVED AND THE PATIENTS GROIN WAS CLOSED WITH A CLOSURE DEVICE. SHE WOKE UP AND WENT HOME ON FRIDAY. A CONSTANT AND DEDICATED SALINE SOURCE WAS USED WITH ALL DEVICES, AND ALL THE DEVICES WERE REMOVED INTACT FROM THE PATIENT. NONE OF THE DEVICES STRETCHED. THE DEVICE THAT WAS IMPLANTED WAS SEEN DURING THE EMERGENT CT AND SURGERY, AND THE DEVICE REMAINED IN PLACE AND DID NOT MIGRATE OR STRETCHED. NO RESISTANCE OCCURRED WITH THE COIL AND MICROCATHETER, BUT THERE WAS RESISTANCE WHEN RELOADING THE ENTERPRISE STENT BACK INTO THE PS+ MICROCATHETER. HOWEVER, THE DEVICE WAS PULLED BACK AND USED TO ASSIST IN ANCHORING THE OTHER MICROCATHETER. DURING THE TIME THE COIL WAS SET IN THE BACK TABLE, THE DEVICE WAS CLEANSE AND FLUSHED OUT, AND NO DEBRIS WAS NOTED ON THE DEVICE. DURING THE CASE, ALL WENT WELL AND NOT DEVICE STRETCHED ALL WENT WELL UNTIL THE PATIENT RETURNED WITH THE EVENT TWO DAYS LATER. MEDICATIONS USED CONSISTED OF HEPARIN, PLAVIX, AND ASA, AND THE ANEURYSM WAS LOCATED IN RIGHT CAROTID ANEURYSM WITH A SIDE WALL ANEURYSM THAT MEASURED 2.5 X 3 MM. THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE PRODUCTS WERE NOT RETURNED FOR ANALYSES. ADDITIONALLY, THE DHR REVIEW COULD NOT BE PERFORMED, SINCE THE LOT NUMBERS WERE NOT PROVIDED. THE MASS FOUND DURING SURGERY WAS ANALYZED BY THE HOSPITAL PATHOLOGY, AND DETERMINED TO BE SUTURE LIKE MATERIAL. HOWEVER, SINCE THE DEVICES WERE DISCARDED IT IS NOT POSSIBLE TO CONFIRM IF THE DEVICE OR DEVICES USED CONTRIBUTED TO THE EVENT. EMBOLIC EVENTS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THIS TYPES OF PROCEDURES, AND THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUE RELATED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. (B)(4). THIS REPORT IS FOR COMPLAINT (B)(4) AND IS ASSOCIATED WITH OTHER DEVICES.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PROWLER LPES MICROCATHETER WAS KICKED OUT OF THE ANEURYSM MULTIPLE TIMES WHEN USING THE 2.5 X 5 GALAXY COIL AND 2.5 X 3.5 MM GALAXY COIL, AND TWO DAYS AFTER THE PROCEDURE, THE PATIENT WAS FOUND UNRESPONSIVE BY HER FAMILY AND TAKEN BACK TO THE HOSPITAL. CT¿S AND WERE DONE AND IT WAS DETERMINED SHE WAS HAVING A RUPTURE EVENT IN THE MCA IN THE SAME ARTERY DISTAL TO WHERE THE ANEURYSM THAT WAS TREATED. SHE WAS TAKEN TO SURGERY TO EVACUATE THE HEMATOMA, AND HE NOTED A DARK NODULE IN THE MCA. THE NODULE WAS EXCISED AND SENT IT TO PATHOLOGY. THE PATIENT NEVER WOKE UP AFTER SURGERY AND EXPIRED. PATHOLOGY LOOKED AT THE TISSUE THAT WAS EXCISED AND THEY NOTED CLOT AND A SUTURE LIKE MATERIAL. THE COIL NEVER STRETCHED SO IT IS VERY UNLIKELY THE INNER STRETCH RESISTANT SUTURE MATERIAL FROM THE COILS EMBOLIZED. HOWEVER, THE PHYSICIAN SPECULATED THAT IT COULD BE MATERIAL FROM THE INSIDE OF ONE OF THE MICROCATHETERS SHEARING OFF DURING THE CASE, SINCE THERE WERE NO ISSUES NOTED WITH THE ENVOY DA. ANALYSIS FROM THEIR PATHOLOGY DEPARTMENT WILL BE PROVIDED ONCE THE FINAL ANALYSIS OF THE MATERIAL THAT WAS FOUND IS COMPLETED. ALL OF THE RESOURCES USED DURING THIS CASE WERE THROW AWAY SO NOTHING WILL BE RETURNED, AND THE LOT NUMBERS FOR THE UNITS WERE NOT KNOWN. ADDITIONAL INFORMATION INDICATED THAT THE SITE (MCA) OF THE EVENT WAS NOT COMPROMISED DURING THE INDEX PROCEDURE, AND ALL LABELING GUIDELINES WERE FOLLOWED INCLUDING DEDICATED DRIP. THERE WAS NO RESISTANCE AT ANY TIME DURING THE CASE THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE PATHOLOGY MICROSCOPIC DESCRIPTION PERFORMED BY THE HOSPITAL INDICATED THAT THERE WAS ABUNDANT POLARIZABLE FOREIGN MATERIAL ASSOCIATED WITH MARKED ACUTE INFLAMMATION. THIS IS SURROUNDED BY AREAS OF FRESH HEMORRHAGE AND BLOOD CLOT. THE PRECISE NATURE OF THE FOREIGN MATERIAL IS UNCERTAIN, BUT IT RESEMBLES SUTURE. THEN, THE INITIAL 2.5 X 5 GALAXY COIL WAS USED SINCE IT WAS .012 COIL VS THE .010 STRYKER COIL. IT WAS ADVANCED AND THIS TIME SUCCESSFULLY DEPLOYED AND DETACHED IN THE ANEURYSM. AFTER 4.5 HOURS WORKING ON THIS PATIENT, THE PHYSICIANS DECIDED THAT ONE COIL WAS ALL NEEDED, AND THEY WERE DONE. THEY REMOVED THE ENTERPRISE AND PROWLER SELECT PLUS SUCCESSFULLY AND IT WAS NEVER DEPLOYED AS AN IMPLANT IN THE PATIENT. THEY THEN REMOVED THE OTHER PROWLER AND DID THE FOLLOW UP POST CASE ANGIOGRAMS AND THEY LOOKED VERY GOOD. THE ENVOY DA WAS REMOVED AND THE PATIENTS GROIN WAS CLOSED WITH A CLOSURE DEVICE. SHE WOKE UP AND WENT HOME ON FRIDAY. A CONSTANT AND DEDICATED SALINE SOURCE WAS USED WITH ALL DEVICES, AND ALL THE DEVICES WERE REMOVED INTACT FROM THE PATIENT. NONE OF THE DEVICES STRETCHED. THE DEVICE THAT WAS IMPLANTED WAS SEEN DURING THE EMERGENT CT AND SURGERY, AND THE DEVICE REMAINED IN PLACE AND DID NOT MIGRATE OR STRETCHED. NO RESISTANCE OCCURRED WITH THE COIL AND MICROCATHETER, BUT THERE WAS RESISTANCE WHEN RELOADING THE ENTERPRISE STENT BACK INTO THE PS+ MICROCATHETER. HOWEVER, THE DEVICE WAS PULLED BACK AND USED TO ASSIST IN ANCHORING THE OTHER MICROCATHETER. DURING THE TIME THE COIL WAS SET IN THE BACK TABLE, THE DEVICE WAS CLEANSE AND FLUSHED OUT, AND NO DEBRIS WAS NOTED ON THE DEVICE. DURING THE CASE, ALL WENT WELL AND NOT DEVICE STRETCHED ALL WENT WELL UNTIL THE PATIENT RETURNED WITH THE EVENT TWO DAYS LATER. MEDICATIONS USED CONSISTED OF HEPARIN, PLAVIX, AND ASA, AND THE ANEURYSM WAS LOCATED IN RIGHT CAROTID ANEURYSM WITH A SIDE WALL ANEURYSM THAT MEASURED 2.5 X 3 MM. THE DEVICES WERE DISCARDED AND NOT AVAILABLE FOR ANALYSIS. ADDITIONALLY, THE LOT NUMBERS WERE NOT PROVIDED, THEREFORE NO DHR COULD BE CONDUCTED. HOWEVER, A SLIDE WITH THE SPECIMEN FOUND WAS SENT FOR ANALYSIS. THE REPORTED EVENT WITH THE DEVICES COULD NOT BE CONFIRMED, SINCE THE DEVICES WERE NOT RETURNED FOR ANALYSIS. ADDITIONALLY, NO DHR REVIEW COULD BE CONDUCTED, SINCE NO LOT NUMBERS WERE PROVIDED. A PLASTIC CONTAINER WAS RECEIVED INSIDE OF A PLASTIC BAG. INSIDE OF THE RECEIVED PLASTIC CONTAINER A STAINED SLIDE WAS FOUND. THE STAINED SLIDE WAS INSPECTED UNDER MICROSCOPE AND OBSERVED A DRY STAINED RED/PINK COLOR. THE STAINED SLIDE WAS SENT TO ANALYTICAL LABORATORY TO TRY TO IDENTIFY THE CHEMICAL COMPOSITION OF THE RECEIVED SAMPLE. THE ANALYTICAL LABORATORY ANALYSIS REPORT CONCLUDES THAT NONE OF THE OBSERVED MATERIAL COULD BE ISOLATED DUE TO THE SLIDE WAS COMPLETELY SEALED AND IF THE CRYSTAL WAS FORCED THERE WAS THE RISK OF DESTROY THE SAMPLE CONTINENT, MOREOVER THE APPROXIMATE DIMENSION OF THE MATERIAL OBSERVED WAS BELOW 2.5 MICROMETERS, THIS SIZE OF THE SAMPLE IS TOO SMALL TO BE ANALYZED THRU ROUTINE ATR-FTIR SYSTEM. IDENTIFICATION TEST OVER THE SAMPLES CONTAINED IN THE SLIDE WAS NOT PERFORMED DUE TO THE SIZE OF THE MATERIAL DETECTED; IN ADDITION THE SLIDE WAS RECEIVED COMPLETELY SEALED. DURING THE VISUAL EXAMINATION PERFORMED, IT WAS NOTICED THE PRESENCE OF A "FIBER-LIKE" MATERIAL, HOWEVER THE SIZE OF ITS MATERIAL IS APPROXIMATELY OF 2¿M; HENCE STATE THIS FIBER-LIKE MATERIAL AS SUTURE IS VERY UNLIKELY. THE DHR CANNOT BE PERFORMED DUE TO THE LOT NUMBER WAS NOT PROVIDED. THE REPORTED FAILURE AS ¿CBS ¿ RESISTANCE/FRICTION¿ COULD NOT BE EVALUATED DUE TO THE PRODUCT WAS NOT RECEIVED. THE REPORTED FAILURE AS ¿COATING ¿ SEPARATED¿ COULD NOT BE EVALUATED DUE TO SAMPLES FOUND ON THE STAINED SLIDE WERE BELOW TO 2.5 MICROMETERS AND CANNOT BE CONCLUSIVELY DETERMINED IF THIS SAMPLES ARE PART OF THE ONE OF THE USED PRODUCTS DURING THE INTERVENTION. ADDITIONALLY INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROWLER LPES MICROCATHETER WAS KICKED OUT OF THE ANEURYSM MULTIPLE TIMES WHEN USING THE 2.5 X 5 GALAXY COIL AND 2.5 X 3.5 MM GALAXY COIL, AND TWO DAYS AFTER THE PROCEDURE, THE PATIENT WAS FOUND UNRESPONSIVE BY HER FAMILY AND TAKEN BACK TO THE HOSPITAL. CT¿S AND WERE DONE AND IT WAS DETERMINED SHE WAS HAVING A RUPTURE EVENT IN THE MCA IN THE SAME ARTERY DISTAL TO WHERE THE ANEURYSM THAT WAS TREATED. SHE WAS TAKEN TO SURGERY TO EVACUATE THE HEMATOMA, AND HE NOTED A DARK NODULE IN THE MCA. THE NODULE WAS EXCISED AND SENT IT TO PATHOLOGY. THE PATIENT NEVER WOKE UP AFTER SURGERY AND EXPIRED. PATHOLOGY LOOKED AT THE TISSUE THAT WAS EXCISED AND THEY NOTED CLOT AND A SUTURE LIKE MATERIAL. THE COIL NEVER STRETCHED SO IT IS VERY UNLIKELY THE INNER STRETCH RESISTANT SUTURE MATERIAL FROM THE COILS EMBOLIZED. HOWEVER, THE PHYSICIAN SPECULATED THAT IT COULD BE MATERIAL FROM THE INSIDE OF ONE OF THE MICROCATHETERS SHEARING OFF DURING THE CASE, SINCE THERE WERE NO ISSUES NOTED WITH THE ENVOY DA. ANALYSIS FROM THEIR PATHOLOGY DEPARTMENT WILL BE PROVIDED ONCE THE FINAL ANALYSIS OF THE MATERIAL THAT WAS FOUND IS COMPLETED. ALL OF THE RESOURCES USED DURING THIS CASE WERE THROW AWAY SO NOTHING WILL BE RETURNED, AND THE LOT NUMBERS FOR THE UNITS WERE NOT KNOWN. ADDITIONAL INFORMATION INDICATED THAT THE SITE (MCA) OF THE EVENT WAS NOT COMPROMISED DURING THE INDEX PROCEDURE, AND ALL LABELING GUIDELINES WERE FOLLOWED INCLUDING DEDICATED DRIP. THERE WAS NO RESISTANCE AT ANY TIME DURING THE CASE THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE PATHOLOGY MICROSCOPIC DESCRIPTION PERFORMED BY THE HOSPITAL INDICATED THAT THERE WAS ABUNDANT POLARIZABLE FOREIGN MATERIAL ASSOCIATED WITH MARKED ACUTE INFLAMMATION. THIS IS SURROUNDED BY AREAS OF FRESH HEMORRHAGE AND BLOOD CLOT. THE PRECISE NATURE OF THE FOREIGN MATERIAL IS UNCERTAIN, BUT IT RESEMBLES SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827828 PROWLER SELECT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| H| L| R