BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 3846517 · Received June 3, 2014

    Report

    Report Number
    3003793491-2014-00265
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED QUATTRO CATHETER CONFIRMED THE CUSTOMER'S REPORTED ISSUE OF A BALLOON LEAK VIA A SMALL BONDING LEAK OBSERVED DURING PRESSURED LEAK TESTING. THE POTENTIAL CAUSE OF THE BONDING LEAK IS LIKELY TO BE A LATENT HAIRLINE DEFORMITY IN THE BOND AREA THAT EVENTUALLY LEAKED UNDER PRESSURE. THIS IS A RANDOM AND RARE FAILURE AS REFLECTED IN ZOLL'S EXTREMELY LOW BALLOON FAILURE RATE. ALL CATHETERS GO THROUGH A THOROUGH 100% INSPECTION AND TEST PRIOR TO AND DURING CATHETER ASSEMBLY PROCESS TO ENSURE VISUAL, STRUCTURAL AND FUNCTIONAL INTEGRITY. THIS INCLUDES DESTRUCTIVE TESTING TO VERIFY BURST STRENGTH PRIOR TO LOT RELEASE. DURING MANUFACTURING, 100% OF CATHETERS ARE INFLATED UNDER PRESSURE TO VERIFY THE INTEGRITY OF THE BALLOON. A FULL FUNCTIONAL TESTING INCLUDING BALLOON LEAK AND BURST STRENGTH IS ALSO REPEATED POST-STERILIZATION PRIOR TO RELEASING THE CATHETERS TO INVENTORY. BASED ON THE ADDITIONAL INFORMATION, THE PATIENT HAD SEVERAL COMORBIDITIES INCLUDING DVT IN 2007. ADDITIONALLY, THE PATIENT WAS IN A HIGH RISK CATEGORY FOR DVT. PER CUSTOMER, THERE WAS NO PATIENT INJURY ATTRIBUTED TO THE ZOLL PRODUCT. PER ZOLL LABELING, POSSIBLE COMPLICATIONS WITH CENTRAL VENOUS CATHETERS INCLUDE THROMBOSIS.

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THE REPORT, THERE WERE NO PATIENT INJURY OR DEATH REPORTED AND NO PATIENT INJURY OR DEATH ATTRIBUTABLE TO THE ZOLL PRODUCT. ZOLL HAS NOT RECEIVED THE PRODUCT INVOLVED IN THE COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER: PATIENT ARRIVED POST-CARDIAC ARREST AND WAS TAKEN DIRECTLY TO THE CATH LAB. AN ANGIOGRAM WAS DONE. THE ZOLL CATHETER WAS INSERTED AND THERAPEUTIC HYPOTHERMIA THERAPY WITH THE IVTM SYSTEM WAS INITIATED. INSERTION WAS SMOOTH AND MADE IN ONE ATTEMPT. NO OTHER CATHETER OR CENTRAL VENOUS CATHETER (CVC) LINE WAS USED. PER HOSPITAL PROTOCOL, PATIENT WAS PLACED ON DVT PROPHYLAXIS (HEPARIN DRIP). IN ADDITION, PER HOSPITAL PROTOCOL, ROUTINE ECHO WAS PERFORMED ON (B)(6) 2014 AND INDICATED THAT THERE WAS A SMALL CLOT ON THE WALL OF THE IVC. INITIAL CATHETER WAS REPLACED WITH ANOTHER QUATTRO CATHETER (LOT NUMBER UNKNOWN). UPON REMOVAL OF THE CATHETER, THE RESIDENT DID NOT NOTE A CLOT. ON (B)(6) 2014, A SECOND SCAN SHOWED AN EXTENSIVE, NON-OCCLUSIVE CLOT THROUGH ALMOST THE ENTIRE LENGTH OF IVC. QUATTRO CATHETER WAS REMOVED AND PER THE HOSPITAL PROTOCOL, THE PATIENT WAS MAINTAINED ON HEPARIN DRIP TO MITIGATE THE DVT. PATIENT EXPIRED ON (B)(6) 2014 DUE TO RETROPERITONEAL BLEED. PER THE NURSE EDUCATOR, THE PATIENT'S DEATH WAS NOT ATTRIBUTED TO THE ZOLL DEVICE AT ALL SINCE PATIENT EXPIRED SEVERAL DAYS AFTER COOLING THERAPY. PATIENT HAD SEVERAL COMORBIDITIES INCLUDING DVT IN 2007 AND WAS IN A HIGH RISK CATEGORY FOR DVT.

    Description of Event or Problem · 1

    AN (B)(6) MALE (B)(6) WAS ADMITTED INTO THE HOSPITAL POST ARREST. ON (B)(6) 2014, A ZOLL QUATTRO CATHETER WAS INSERTED INTO THE LEFT FEMORAL VEIN OF THE PATIENT. DURING THE DAY, PATIENT ARRIVED FROM THE CATH LAB WITH THE ZOLL CATHETER IN PLACE, THE TUBING PRIMED AND THE CONSOLE ATTACHED. THERE WERE NO OTHER TEMPERATURE MANAGEMENT OR RELATIVE PROCEDURES PERFORMED ON THE PATIENT PRIOR TO COOLING. THE PATIENT'S TEMPERATURE AT THE START OF IVTM THERAPY WAS 33.2. THE TARGET TEMPERATURE WAS SET TO 34 DEGREES. IN THE EVENING, THE NURSE NOTED THAT THE SALINE HAD GONE FROM THE BAG. HOWEVER, THERE WAS NO FLUID FOUND ON THE FLOOR, BED OR CONSOLE. THE NURSES REPRIMED AND RAN THE SET-UP BUT THERE WAS A LOSS OF FLUID AGAIN. USING THE ZOLL MANUAL, THE CATHETER BALLOONS WERE CHECKED FOR LEAKS. NO BLOOD CAME BACK INTO THE SYRINGE WHEN THE VACUUM WAS PULLED, INDICATING THAT THE CATHETER WAS OK. THE AIR ALARM WAS NOTED DURING TREATMENT AT 34 DEGREES. THE SUK AND THE SALINE BAG WERE CHANGED BECAUSE THE NURSE WAS UNSURE WHERE THE LEAK WAS COMING FROM. AS THERE CONTINUED TO BE A SLOW LEAK, THE CATHETER WAS CHANGED AND REPLACED ON (B)(6) 2014. THE CONSOLE WAS ALSO CHANGED OUT. UPON REMOVAL OF THE CATHETER, THE RESIDENT CHECKING THE CATHETER NOTED THAT THERE WAS A VERY SMALL LEAK BETWEEN THE MOST PROXIMAL AND SECOND BALLOON ON THE CATHETER. AN ECHO WAS DONE AND THERE WAS "QUERY" OF A SMALL CLOT EITHER ON THE WALL OF THE INFERIOR VENA CAVA (IVC) OR ON THE ZOLL CATHETER. PATIENT REMAINS SEDATED, VENTILATED AND READY FOR EXTUBATION. HE OBEYS COMMANDS BUT IS VERY WEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324559 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION, INC 8700-0697-40 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other