QUATTRO® Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin E IC-4593AERecalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 00849111075275), received between Oct 20, 2017 and Sep 23, 2026 — classified as 2 deaths, 11 injuries, 85 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (63 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Fluid/Blood Leak; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876460 ↗
• MalfunctionApr 23, 2026Fluid/Blood Leak; Material Integrity Problem

  THE QUATTRO CATHETER (LOT#: 209655) WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN TO INDUCE HYPOTHERMIA. APPROXIMATELY 20 HOURS INTO TREATMENT, DURING THE COOLING PHASE, THE THERMOGARD SYSTEM GENERATED AN "AIR TRAP" ALARM. THE 500-ML SALINE BAG WAS FOUND TO BE EMPTY. THERE WAS NO FLUID ON THE FLOOR, THE PATIENT'S BED, OR THE CONSOLE. THE QUATTRO CATHETER WAS REMOVED. THE CUSTOMER REPORTED OBSERVING A DAMAGED BALLOON AND SUSPECTED THAT APPROXIMATELY 200 ML OF SALINE MAY HAVE INFUSED INTO THE PATIENT'S BLOODSTREAM. THE CATHETER WAS REPLACED, AND TREATMENT CONTINUED AND COMPLETED USING THE SAME THERMOGARD CONSOLE. NO PATIENT INJURY OCCURRED, AND THE PATIENT REMAINED ALIVE AND STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24974070 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT WITH TRAUMATIC BRAIN INJURY (TBI) RECEIVED IVTM THERAPY FOR FEVER MANAGEMENT. THE QUATTRO CATHETER (LOT # UNKNOWN) WAS SMOOTHLY INSERTED INTO THE PATIENT'S FEMORAL VEIN IN A SINGLE ATTEMPT. NO ADDITIONAL TEMPERATURE MANAGEMENT OR RELATED PROCEDURES WERE PERFORMED PRIOR TO THE IVTM TREATMENT. ACCORDING TO THE PROVIDER, THE PATIENT WAS CONSIDERED HIGH RISK FOR DEEP VEIN THROMBOSIS (DVT) DUE TO THEIR INTENSIVE CARE STATUS. COAGULATION RESULTS WERE AVAILABLE BEFORE THERAPY STARTED. THE PROVIDER REPORTED AN OCCURRENCE OF DEEP VEIN THROMBOSIS WITH PULMONARY EMBOLISM; HOWEVER, NO FURTHER DETAILS WERE PROVIDED TO CLARIFY WHETHER THE PATIENT EXPERIENCED BOTH CONDITIONS. THE DVT WAS IN THE SAME VESSEL WHERE THE CATHETER WAS PLACED. DVT PROPHYLAXIS CONSISTED OF APPROXIMATELY 400-500 I.E. OF HEPARIN PER HOUR, WITH HIGHER DOSES GIVEN WHEN THERE WAS NO EVIDENCE OF CEREBRAL HEMORRHAGE. THE CATHETER REMAINED IN PLACE FOR A TOTAL DWELL TIME OF 96 HOURS. NO FURTHER INFORMATION WAS PROVIDED ON THE PATIENT'S CONDITION.

  Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 24654360 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT WITH TRAUMATIC BRAIN INJURY (TBI) RECEIVED IVTM THERAPY FOR FEVER MANAGEMENT. THE QUATTRO CATHETER (LOT # UNKNOWN) WAS SMOOTHLY INSERTED INTO THE PATIENT'S FEMORAL VEIN IN A SINGLE ATTEMPT. NO ADDITIONAL TEMPERATURE MANAGEMENT OR RELATED PROCEDURES WERE PERFORMED PRIOR TO THE IVTM TREATMENT. ACCORDING TO THE PROVIDER, THE PATIENT WAS CONSIDERED HIGH RISK FOR DEEP VEIN THROMBOSIS (DVT) DUE TO THEIR INTENSIVE CARE STATUS. COAGULATION RESULTS WERE AVAILABLE BEFORE THERAPY STARTED. THE PROVIDER REPORTED AN OCCURRENCE OF DEEP VEIN THROMBOSIS WITH PULMONARY EMBOLISM; HOWEVER, NO FURTHER DETAILS WERE PROVIDED TO CLARIFY WHETHER THE PATIENT EXPERIENCED BOTH CONDITIONS. THE DVT WAS IN THE SAME VESSEL WHERE THE CATHETER WAS PLACED. DVT PROPHYLAXIS CONSISTED OF APPROXIMATELY 400-500 I.E. OF HEPARIN PER HOUR, WITH HIGHER DOSES GIVEN WHEN THERE WAS NO EVIDENCE OF CEREBRAL HEMORRHAGE. THE CATHETER REMAINED IN PLACE FOR A TOTAL DWELL TIME OF 96 HOURS. NO FURTHER INFORMATION WAS PROVIDED ON THE PATIENT'S CONDITION.

  Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 24654304 ↗
• InjuryDec 17, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE QUATTRO CATHETER (LOT #208953) WAS SMOOTHLY INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN TO INDUCE HYPOTHERMIA FOLLOWING CARDIAC ARREST. THE PATIENT'S INITIAL BODY TEMPERATURE AT THE START OF TREATMENT WAS 36 °C. THE TARGET TEMPERATURE WAS SET AT 34 °C, WITH THE MAXIMUM COOLING RATE APPLIED. DURING THE FIRST PHASE OF THE TREATMENT, THE 500-ML SALINE BAG WAS EMPTY, AND THE THERMOGARD SYSTEM GENERATED AN "AIR TRAP" ALARM. THE PUMP ROTOR STOPPED, AND THE CONSOLE ENTERED STANDBY MODE. THERE WAS NO LEAKAGE FROM THE START-UP KIT (SUK), AND NO FLUID WAS SEEN ON OR UNDER THE THERMOGARD CONSOLE. IT WAS THEREFORE SUSPECTED THAT THE CATHETER LEAKED. AN INFUSION OF 250 MILLILITERS OF SALINE WAS SUSPECTED TO HAVE ENTERED THE PATIENT'S BLOODSTREAM. THE CATHETER WAS REPLACED. THE DWELL TIME OF THE CATHETER WAS 2 TO 4 HOURS. AFTERWARDS, THE "AIR TRAP" ALARM CLEARED, AND THE TREATMENT WAS CONTINUED AND COMPLETED USING THE SAME THERMOGARD CONSOLE. NO PATIENT INJURY WAS REPORTED. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23833948 ↗
• MalfunctionSep 16, 2025Difficult to Insert; Difficult to Insert

  THE CUSTOMER REPORTED AN INABILITY TO ADVANCE THE CATHETER OVER THE GUIDEWIRE WHILE ATTEMPTING TO INSERT THE QUATTRO CATHETER TO INITIATE IVTM THERAPY FOR A 39-YEAR-OLD MALE PATIENT (WEIGHT: 85 KG). THE CUSTOMER EXPERIENCED THE SAME ISSUE WITH TWO QUATTRO CATHETERS (LOT #208148 AND 209490). ADDITIONALLY, THE CUSTOMER REPORTED THAT THE VESSEL DILATOR GOT KINKED WHEN ATTEMPTING TO DILATE THE BLOOD VESSEL FOR CATHETER INSERTION. WHEN ATTEMPTING TO PULL THE GUIDEWIRE OUT OF THE CATHETER, THE WIRE MESH CAME APART EASILY, MAKING THE GUIDEWIRE UNUSABLE FOR ANOTHER PUNCTURE ATTEMPT. THE CUSTOMER WAS ABLE TO INSERT ANOTHER QUATTRO CATHETER WITHOUT ANY PROBLEMS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066502 ↗
• MalfunctionSep 16, 2025Difficult to Insert; Difficult to Insert

  THE CUSTOMER REPORTED AN INABILITY TO ADVANCE THE CATHETER OVER THE GUIDEWIRE WHILE ATTEMPTING TO INSERT THE QUATTRO CATHETER TO INITIATE IVTM THERAPY FOR A 39-YEAR-OLD MALE PATIENT (WEIGHT: 85 KG). THE CUSTOMER EXPERIENCED THE SAME ISSUE WITH TWO QUATTRO CATHETERS (LOT #208148 AND 209490). ADDITIONALLY, THE CUSTOMER REPORTED THAT THE VESSEL DILATOR GOT KINKED WHEN ATTEMPTING TO DILATE THE BLOOD VESSEL FOR CATHETER INSERTION. WHEN ATTEMPTING TO PULL THE GUIDEWIRE OUT OF THE CATHETER, THE WIRE MESH CAME APART EASILY, MAKING THE GUIDEWIRE UNUSABLE FOR ANOTHER PUNCTURE ATTEMPT. THE CUSTOMER WAS ABLE TO INSERT ANOTHER QUATTRO CATHETER WITHOUT ANY PROBLEMS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066436 ↗
• MalfunctionSep 9, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE IVTM THERAPY WAS INITIATED FOR A 75-YEAR-OLD MALE PATIENT (BODY WEIGHT: 100 KG) FOLLOWING CARDIAC ARREST. COOLING WAS PERFORMED WITH THE QUATTRO CATHETER (LOT# 208095) VIA RIGHT FEMORAL INSERTION, WHICH WAS COMPLETED SMOOTHLY WITHOUT MULTIPLE ATTEMPTS. THE PATIENT'S INITIAL TEMPERATURE AT THE START OF THERAPY WAS 36.5°C, WITH A TARGET TEMPERATURE OF 34°C. AFTER 10 MINUTES OF THERAPY, THE CONSOLE STOPPED AS THE SALINE LEVEL HAD DECREASED IN THE BAG. NO SALINE WAS OBSERVED AROUND THE INSERTION SITE OR THE BED. PER THE INSTRUCTIONS FOR USE (IFU), THE CATHETER WAS CHECKED FOR LEAKAGE. THE CUSTOMER SUSPECTED THE 250ML SALINE INFUSION INTO THE PATIENT'S BLOODSTREAM. THE PHYSICIAN REPLACED THE CATHETER TO CONTINUE THE THERAPY. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23002709 ↗
• MalfunctionSep 4, 2025Use of Device Problem; Use of Device Problem

  THE QUATTRO CATHETER (LOT #208095) WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN TO COOL THE PATIENT AFTER CARDIAC ARREST. THE PATIENT'S BODY TEMPERATURE AT THE START OF TREATMENT WAS 36.5 °C, AND THE TARGET TEMPERATURE WAS SET AT 34 °C, WITH THE MAXIMUM COOLING RATE APPLIED. THE CUSTOMER REPORTED THAT 10 MINUTES AFTER INSERTION, IT WAS NOT POSSIBLE TO "FILL" THE QUATTRO CATHETER. THE CUSTOMER DID NOT PROVIDE FURTHER CLARIFICATION ON THE ISSUE. THE PHYSICIAN REPLACED THE CATHETER, AND IT WORKED WELL WITHOUT ANY PROBLEMS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22972918 ↗
• MalfunctionAug 20, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER REPORTED LEAKAGE OF SALINE INTO THE INJECTION CHANNEL. THERE IS A SUSPECTED LEAK OF THE QUATTRO CATHETER (LOT 198225), CAUSING LEAKAGE OF SALINE INTO THE PATIENT'S BLOOD. THE 500 ML SALINE BAG WAS EMPTY. THE CATHETER WAS REMOVED AND NOT REPLACED. THE ISSUE WAS NOTICED DURING THE FIRST HOURS OF THERAPY. NO CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851819 ↗
• MalfunctionJun 4, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AFTER PLACING THE QUATTRO CATHETER (LOT 207662), IT WAS NOTICED THAT THE 500 ML NACL BAG HAD RUN OUT, NO OTHER LEAKAGE COULD BE DETECTED. THE CATHETER HAD BEEN SMOOTHLY INSERTED INTO THE RIGHT FEMORAL VEIN OF THE 66-YEAR-OLD, 180 KG MALE PATIENT. THE CATHETER WAS REMOVED. NO IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143724 ↗
• MalfunctionFeb 12, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  IVTM THERAPY WAS INITIATED FOR A PATIENT UTILIZING A QUATTRO CATHETER (LOT # 204002) TO ADDRESS HYPOTHERMIA. THE CATHETER WAS PLACED INTO THE LEFT FEMORAL VEIN. AFTER 30 HOURS OF THERAPY, IT WAS OBSERVED THAT THE 500 ML SALINE BAG WAS EMPTY. NO EXTERNAL SALINE LEAKS WERE NOTED BY THE CUSTOMER. THE CUSTOMER PERFORMED THE CATHETER LEAK CHECK PER IFU. THE CUSTOMER SUSPECTED THE 200-250ML SALINE INFUSION INTO THE PATIENT'S BLOODSTREAM. THE CATHETER WAS REPLACED TO CONTINUE THE TEMPERATURE MANAGEMENT THERAPY UTILIZING THE SAME CONSOLE AS IT WAS VERIFIED TO BE FUNCTIONAL. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21368791 ↗
• MalfunctionFeb 5, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER REPORTED THE QUATTRO CATHETER (LOT UNKNOWN) HAS A LEAK. THE CATHETER WAS SMOOTHLY INSERTED ON THE FIRST ATTEMPT INTO THE RIGHT FEMORAL VEIN OF AN 84 KG MALE PATIENT. THE LEAK WAS SPOTTED SOMETIME AFTER INSERTION BECAUSE THE RED PINWHEEL ON THE START-UP KIT (SUK) DIDN´T ROTATE AND THE SALINE SOLUTION VOLUME HAD DECREASED. NO LEAKED FLUID WAS OBSERVED ON OR AROUND THE CONSOLE OR PATIENT. THE DWELL TIME IS UNKNOWN. THE CUSTOMER PERFORMED A LEAK CHECK PER IFU AND REMOVED THE CATHETER. THEY SPOTTED A LEAK AND ACCIDENTALLY THREW THE CATHETER AWAY. IT WAS REPLACED WITH A NEW CATHETER WITHOUT ANY PROBLEMS. NO IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315600 ↗
• MalfunctionFeb 4, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A 70-YEAR-OLD MALE PATIENT (90 KG) RECEIVED IVTM THERAPY FOLLOWING CPR AND VENTRICULAR FIBRILLATION. THE QUATTRO CATHETER (LOT # 198059) WAS SUCCESSFULLY INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN ON THE FIRST ATTEMPT. THE PATIENT'S TEMPERATURE AT THE START OF THERAPY WAS 36°C, WITH A TARGET TEMPERATURE OF 34°C AT THE MAX RATE. DURING TREATMENT, THE SALINE BAG WAS FOUND EMPTY, TRIGGERING AN AIR TRAP ALARM ON THE CONSOLE. INSPECTION PER INSTRUCTIONS FOR USE (IFU) IDENTIFIED A LEAK AT THE PROXIMAL INFUSION OPENING OF THE CATHETER. SUBSEQUENTLY, A REPLACEMENT QUATTRO CATHETER (LOT # 198059) WAS USED; HOWEVER, ANOTHER SALINE DECREASE OCCURRED AFTER AN UNSPECIFIED PERIOD, AGAIN REVEALING A LEAK AT THE PROXIMAL INFUSION SITE UPON INSPECTION. PER THE REPORTER, THE INFUSION OF 500 ML INTO THE PATIENT'S BLOODSTREAM WAS SUSPECTED. PER THE REPORTER, THE CONSOLE WAS DETERMINED TO BE FUNCTIONAL. FOLLOWING TWO UNSUCCESSFUL ATTEMPTS, THE PHYSICIAN DETERMINED TO DISCONTINUE TEMPERATURE MANAGEMENT FOR THE PATIENT. NO FURTHER DETAILS WERE PROVIDED IF AN ALTERNATIVE TEMPERATURE MANAGEMENT THERAPY WAS UTILIZED. THE PATIENT IS STABLE, AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21301742 ↗
• MalfunctionFeb 3, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A 70-YEAR-OLD MALE PATIENT (90 KG) RECEIVED IVTM THERAPY FOLLOWING CPR AND VENTRICULAR FIBRILLATION. THE QUATTRO CATHETER (LOT # 198059) WAS SUCCESSFULLY INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN ON THE FIRST ATTEMPT. THE PATIENT'S TEMPERATURE AT THE START OF THERAPY WAS 36°C, WITH A TARGET TEMPERATURE OF 34°C AT THE MAX RATE. DURING TREATMENT, THE SALINE BAG WAS FOUND EMPTY, TRIGGERING AN AIR TRAP ALARM ON THE CONSOLE. INSPECTION PER INSTRUCTIONS FOR USE (IFU) IDENTIFIED A LEAK AT THE PROXIMAL INFUSION OPENING OF THE CATHETER. SUBSEQUENTLY, A REPLACEMENT QUATTRO CATHETER (LOT # 198059) WAS USED; HOWEVER, ANOTHER SALINE DECREASE OCCURRED AFTER AN UNSPECIFIED PERIOD, AGAIN REVEALING A LEAK AT THE PROXIMAL INFUSION SITE UPON INSPECTION. PER THE REPORTER, THE INFUSION OF 500 ML INTO THE PATIENT'S BLOODSTREAM WAS SUSPECTED. PER THE REPORTER, THE CONSOLE WAS DETERMINED TO BE FUNCTIONAL. FOLLOWING TWO UNSUCCESSFUL ATTEMPTS, THE PHYSICIAN DETERMINED TO DISCONTINUE TEMPERATURE MANAGEMENT FOR THE PATIENT. NO FURTHER DETAILS WERE PROVIDED IF AN ALTERNATIVE TEMPERATURE MANAGEMENT THERAPY WAS UTILIZED. THE PATIENT IS STABLE, AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289973 ↗
• MalfunctionJan 30, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AFTER SMOOTHLY PLACING THE QUATTRO CATHETER (LOT 195538), IT WAS NOTICED THAT THE 500 ML NACL BAG HAD RUN OUT. APPROXIMATELY 250 ML OF SALINE INFUSION INTO THE PATIENT IS SUSPECTED. NO OTHER LEAKAGE COULD BE DETECTED. THERE WAS NO LIQUID AROUND THE THERMOGARD XP IVTM SYSTEM OR THE PATIENT. THE DWELL TIME WAS BETWEEN 16-18 HOURS. THE CATHETER AND SALINE BAG WERE REPLACED TO CONTINUE THERAPY. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275221 ↗
• MalfunctionJan 29, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER REPORTED THE THERMOGARD XP IVTM SYSTEM DISPLAYED AN AIR TRAP ALARM. THE AIR TRAP WAS SLIGHTLY MORE THAN HALF FULL. THERE WAS PROBABLY ALSO SOME BLOOD IN THE TUBE. A LEAK CHECK WAS PERFORMED PER THE IFU. THEY FLUSHED THE QUATTRO CATHETER (LOT 196299) AGAIN, BUT ONLY A LITTLE SALINE CAME OUT OF THE OUTER LUER AND THE SALINE WAS ALSO SLIGHTLY BLOODY. THE CATHETER HAD BEEN SMOOTHLY INSERTED ON THE FIRST ATTEMPT INTO THE LEFT FEMORAL VEIN OF A 63-YEAR-OLD, 130KG MALE PATIENT. THE DWELL TIME WAS 10 HOURS. THE CATHETER WAS NOT REPLACED. THE ALARM ON THE CONSOLE WAS CLEARED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21270316 ↗
• MalfunctionDec 30, 2024Difficult to Advance; Difficult to Advance

  THE CUSTOMER REPORTED AN ISSUE WITH ADVANCING THE QUATTRO CATHETER (LOT # 200089) AND RETRACTING THE GUIDEWIRE DURING CATHETER INSERTION INTO A PATIENT'S FEMORAL VEIN. THE GUIDEWIRE BECAME STUCK AND COULD NOT BE REMOVED, SO BOTH THE CATHETER AND GUIDEWIRE WERE TAKEN OUT TOGETHER WITHOUT ANY SURGICAL INTERVENTION OR ISSUES. A NEW GUIDEWIRE WAS USED TO INSERT A REPLACEMENT CATHETER AT THE SAME INSERTION SITE. THIS INCIDENT OCCURRED IN THE PAST AND WAS NOT REPORTED TO ZOLL AT THE TIME. UNFORTUNATELY, THE ATTENDING PHYSICIAN NO LONGER RECALLS WHICH PATIENT IT WAS, ONLY THAT THE PATIENT HAD DIED FROM ANOTHER CAUSE. THE CUSTOMER SUSPECTS THAT THERE WAS A TIGHTER BEND IN THE VESSEL, WHICH MADE IT SOMEWHAT MORE DIFFICULT TO ADVANCE THE CATHETER AND REMOVE THE GUIDEWIRE. NO PATIENT INJURY RELATED TO THE ZOLL DEVICE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044635 ↗
• MalfunctionDec 6, 2024Difficult to Insert; Difficult to Insert

  DURING MULTIPLE ATTEMPTS, THE CUSTOMER HAD DIFFICULTY REMOVING THE GUIDEWIRE FROM THE QUATTRO CATHETER. THREE QUATTRO CATHETERS AND ZOLL GUIDEWIRES WERE ATTEMPTED TO INSERT INTO THE FEMORAL VEIN (RIGHT AND LEFT SIDES). EACH ATTEMPT WAS DIFFICULT AND REQUIRED MULTIPLE INSERTIONS. THE CUSTOMER REPORTED THAT THE GUIDEWIRE COULD NOT BE REMOVED FROM ANY OF THE THREE CATHETERS, AND THE CATHETER HAD TO BE REMOVED ALONG WITH THE GUIDEWIRE EACH TIME. PER THE CUSTOMER, THE PHYSICIAN'S EXPERIENCE WITH INTRAVASCULAR CATHETER PLACEMENT WAS FREQUENT, AND PER THE PHYSICIAN, THERE WAS NO INCREASED TORTUOSITY IN THE VEIN. NO PATIENT INJURY WAS REPORTED. THE CUSTOMER SAVED ONLY ONE CATHETER (LOT #198059) WITH GUIDEWIRE (LOT #199681) FOR INVESTIGATION. THE LOT NUMBERS OF THE TWO OTHER CATHETERS AND THE GUIDEWIRES ARE UNKNOWN, AND THE CUSTOMER HAS DISPOSED OF THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860871 ↗
• MalfunctionDec 6, 2024Difficult to Insert; Difficult to Insert

  DURING MULTIPLE ATTEMPTS, THE CUSTOMER HAD DIFFICULTY REMOVING THE GUIDEWIRE FROM THE QUATTRO CATHETER. THREE QUATTRO CATHETERS AND ZOLL GUIDEWIRES WERE ATTEMPTED TO INSERT INTO THE FEMORAL VEIN (RIGHT AND LEFT SIDES). EACH ATTEMPT WAS DIFFICULT AND REQUIRED MULTIPLE INSERTIONS. THE CUSTOMER REPORTED THAT THE GUIDEWIRE COULD NOT BE REMOVED FROM ANY OF THE THREE CATHETERS, AND THE CATHETER HAD TO BE REMOVED ALONG WITH THE GUIDEWIRE EACH TIME. PER THE CUSTOMER, THE PHYSICIAN'S EXPERIENCE WITH INTRAVASCULAR CATHETER PLACEMENT WAS FREQUENT, AND PER THE PHYSICIAN, THERE WAS NO INCREASED TORTUOSITY IN THE VEIN. NO PATIENT INJURY WAS REPORTED. THE CUSTOMER SAVED ONLY ONE CATHETER (LOT #198059) WITH GUIDEWIRE (LOT #199681) FOR INVESTIGATION. THE LOT NUMBERS OF THE TWO OTHER CATHETERS AND THE GUIDEWIRES ARE UNKNOWN, AND THE CUSTOMER HAS DISPOSED OF THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860192 ↗
• MalfunctionDec 5, 2024Difficult to Insert; Difficult to Insert

  DURING MULTIPLE ATTEMPTS, THE CUSTOMER HAD DIFFICULTY REMOVING THE GUIDEWIRE FROM THE QUATTRO CATHETER. THREE QUATTRO CATHETERS AND ZOLL GUIDEWIRES WERE ATTEMPTED TO INSERT INTO THE FEMORAL VEIN (RIGHT AND LEFT SIDES). EACH ATTEMPT WAS DIFFICULT AND REQUIRED MULTIPLE INSERTIONS. THE CUSTOMER REPORTED THAT THE GUIDEWIRE COULD NOT BE REMOVED FROM ANY OF THE THREE CATHETERS, AND THE CATHETER HAD TO BE REMOVED ALONG WITH THE GUIDEWIRE EACH TIME. PER THE CUSTOMER, THE PHYSICIAN'S EXPERIENCE WITH INTRAVASCULAR CATHETER PLACEMENT WAS FREQUENT, AND PER THE PHYSICIAN, THERE WAS NO INCREASED TORTUOSITY IN THE VEIN. NO PATIENT INJURY WAS REPORTED. THE CUSTOMER SAVED ONLY ONE CATHETER (LOT #198059) WITH GUIDEWIRE (LOT #199681) FOR INVESTIGATION. THE LOT NUMBERS OF THE TWO OTHER CATHETERS AND THE GUIDEWIRES ARE UNKNOWN, AND THE CUSTOMER HAS DISPOSED OF THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20859478 ↗
• MalfunctionNov 19, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AN IVTM THERAPY WAS INITIATED FOR A 62-YEAR-OLD MALE PATIENT (WEIGHT: 110 KG), AND THE PRIMARY CAUSE OF HOSPITALIZATION AND NEED FOR IVTM THERAPY WAS SEVERE HYPOTHERMIA. A QUATTRO CATHETER (LOT #201328) WAS INSERTED SMOOTHLY INTO THE PATIENT'S LEFT FEMORAL VEIN. AT THE START OF IVTM THERAPY, THE PATIENT'S TEMPERATURE WAS 29.2°C, AND THE TARGET TEMPERATURE WAS 36°C AT 0.5°C/HOUR. DURING THE THERAPY, THE THERMOGARD XP IVTM SYSTEM GENERATED AN "AIR TRAP WARNING" ALARM, AND THE CUSTOMER NOTED A DECREASING VOLUME OF SALINE IN THE SALINE BAG. NO LEAKED FLUID WAS OBSERVED ON THE THERMOGARD SYSTEM, PATIENT BED, FLOOR, ETC. THE TEMPERATURE AT THE TIME OF THE ISSUE WAS 30.1°C, AND THE DWELL TIME OF THE CATHETER WAS 2 HOURS. THE PATIENT DIED IN THE COURSE OF HIS ITS (INTENSIVE CARE UNIT) TREATMENT AND DURING THE REWARMING PHASE OF THE IVTM THERAPY. AS A CRIMINAL CASE CANNOT BE RULED OUT AS THE CAUSE OF HIS HOSPITALIZATION, THE QUATTRO CATHETER COULD NOT BE REMOVED ACCORDING TO THE INSTRUCTIONS OF THE GERMAN POLICE AND THE LAW. THE CAUSE OF DEATH WAS DUE TO SEVERE HYPOTHERMIA AND THE OVERALL VERY POOR GENERAL CONDITION OF THE PATIENT OR THE SEVERITY OF THE CURRENT ILLNESS AS AN EXPRESSION OF A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20730656 ↗
• MalfunctionSep 26, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE THERMOGARD XP IVTM SYSTEM DISPLAYED AN ALARM TO CHECK THE SALINE SOLUTION LEVEL. THE SALINE BAG WAS EMPTY. THE USERS CHECKED THE CONNECTIONS ON THE CATHETER, START-UP KIT (SUK), AND THE AIR BUBBLE TRAP. NO LEAKAGE WAS FOUND. A LEAK CHECK WAS PERFORMED PER THE CATHETER IFU. THE USERS FLUSHED THE QUATTRO CATHETER (LOT 196842) WITH SALINE AND NO SALINE CAME BACK OUT OF THE CATHETER. SO, THEY DECIDED TO STOP THE THERAPY. THE DWELL TIME WAS 23 HOURS. THE CATHETER WAS INSERTED INTO THE RIGHT FEMORAL VEIN OF THE FEMALE PATIENT SMOOTHLY ON THE FIRST ATTEMPT. THE CATHETER AND SALINE BAG WERE REPLACED TO CONTINUE THERAPY WITH THE SAME CONSOLE. NO IMPACT OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20314055 ↗
• MalfunctionSep 20, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  IVTM THERAPY WAS INITIATED FOR A MALE PATIENT USING A QUATTRO CATHETER (LOT #UNKNOWN), WHICH WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN ON THE FIRST ATTEMPT. THE PATIENT'S INITIAL TEMPERATURE WAS 35.2°C, WITH A TARGET TEMPERATURE OF 37°C SET AT THE MAX RATE. WHEN THE TEMPERATURE REACHED 36.5°C, THE THERMOGARD XP IVTM SYSTEM TRIGGERED AN "AIR TRAP WARNING" ALARM, AND THE CUSTOMER NOTED AN EMPTY SALINE BAG. THE CUSTOMER INSPECTED THE CONNECTIONS ON THE CATHETER, START-UP KIT (SUK), AND THE SUK AIR TRAP, FINDING NO LEAKS. AFTER FLUSHING THE CATHETER WITH SALINE, NO SALINE WAS RETURNED, LEADING THE CUSTOMER TO SUSPECT A CATHETER LEAK AND DECIDE TO STOP AND FINISH THE THERAPY. THE CUSTOMER SUSPECTS 250 ML OF SALINE INFUSION INTO THE PATIENT'S BLOODSTREAM. THE DWELL TIME OF THE CATHETER WAS TWO DAYS. THE AIR TRAP ALARM WAS CLEARED AND THE THERMOGARD SYSTEM WAS PLACED BACK ON THE FLOOR FOR FUTURE CLINICAL USE. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268921 ↗
• MalfunctionAug 6, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AN IVTM THERAPY WAS INITIATED USING A QUATTRO CATHETER (LOT #192200). DURING THE THERAPY, THE THERMOGARD XP IVTM SYSTEM GENERATED AN "AIR TRAP WARNING" ALARM, AND THE SALINE BAG WAS NOTED TO BE EMPTIED. THE START-UP KIT (SUK) AIR TRAP HAD ONLY THREE-QUARTERS OF SALINE-FILLED. THE CUSTOMER CALLED THE ZOLL TECH LINE FOR HELP AND PERFORMED THE LEAK CHECK. A LEAK WAS NOTED FROM THE IN LUER CONNECTION TO THE CATHETER. THE DWELL TIME OF THE CATHETER WAS 32 HOURS. THE CATHETER WAS REPLACED TO CONTINUE THE IVTM THERAPY. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19924762 ↗