Cool Line® Intravascular Heat Exchange Catheter Kit (Non Heparin) CL-2295AERecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00849111075039), received between Feb 15, 2018 and Feb 16, 2018 — classified as 2 deaths, 14 injuries.

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE JOURNAL ARTICLE "ENDOVASCULAR COOLING VERSUS STANDARD FEMORAL CATHETERS AND INTRAVASCULAR COMPLICATIONS: A (B)(6) STUDY," THAT TWELVE (12) PATIENTS IN THE TARGETED TEMPERATURE MANAGEMENT (TTM) GROUP PRESENTED MAJOR COMPLICATIONS. THIS REPORT IS 7 OF 12. ON AN UNSPECIFIED DATE BETWEEN (B)(6) 2012 AND (B)(6) 2014, A COOLGARD CATHETER WAS PLACED IN PATIENT'S FEMORAL VEIN. THE PATIENT WAS FOUND TO HAVE THROMBOTIC COMPLICATIONS DURING COOLING. ACCORDING TO THE PHYSICIAN, THE PATIENT DID NOT HAVE A CATHETER-RELATED BLOODSTREAM INFECTION. THE CATHETER DWELL TIME WAS 4.2 DAYS. IN THE CLINICAL STUDY, THE PHYSICIAN INDICATED THAT THE CATHETERIZATION TIME WAS LONGER THAN RECOMMENDED FOR THE TTM PERIOD FOR COOLGARD CATHETER. THE SPECIFIC CATHETER USED IN THE STUDY HAS NOT BEEN REPORTED TO ZOLL. AS DEFAULT, THE COOL LINE CATHETER WAS SELECTED. PATIENT 1 OF 12 ((B)(4)) - MFR 3010617000-2018-00183, PATIENT 2 OF 12 ((B)(4)) - MFR 3010617000-2018-00184, PATIENT 3 OF 12 ((B)(4)) - MFR 3010617000-2018-00185, PATIENT 4 OF 12 ((B)(4)) - MFR 3010617000-2018-00186, PATIENT 5 OF 12 ((B)(4)) - MFR 3010617000-2018-00187, PATIENT 6 OF 12 ((B)(4)) - MFR 3010617000-2018-00188, PATIENT 8

  Patient problems: Thrombosis

  MAUDE report 7277451 ↗
• InjuryFeb 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE JOURNAL ARTICLE "ENDOVASCULAR COOLING VERSUS STANDARD FEMORAL CATHETERS AND INTRAVASCULAR COMPLICATIONS: A PROPENSITY-MATCHED COHORT STUDY," THAT TWELVE (12) PATIENTS IN THE TARGETED TEMPERATURE MANAGEMENT (TTM) GROUP PRESENTED MAJOR COMPLICATIONS. THIS REPORT IS 8 OF 12. ON AN UNSPECIFIED DATE BETWEEN AUGUST 2012 AND NOVEMBER 2014, A COOLGARD CATHETER WAS PLACED IN PATIENT'S FEMORAL VEIN. THE PATIENT WAS FOUND TO HAVE THROMBOTIC COMPLICATIONS DURING COOLING. ACCORDING TO THE PHYSICIAN, THE PATIENT DID NOT HAVE A CATHETER-RELATED BLOODSTREAM INFECTION. THE CATHETER DWELL TIME WAS 4.2 DAYS. IN THE CLINICAL STUDY, THE PHYSICIAN INDICATED THAT THE CATHETERIZATION TIME WAS LONGER THAN RECOMMENDED FOR THE TTM PERIOD FOR COOLGARD CATHETER. THE SPECIFIC CATHETER USED IN THE STUDY HAS NOT BEEN REPORTED TO ZOLL. AS DEFAULT, THE COOL LINE CATHETER WAS SELECTED. PATIENT 1 OF 12 ((B)(6))- MFR 3010617000-2018-00183, PATIENT 2 OF 12 ((B)(6))- MFR 3010617000-2018-00184, PATIENT 3 OF 12 ((B)(6))- MFR 3010617000-2018-00185, PATIENT 4 OF 12 ((B)(6))- MFR 3010617000-2018-00186, PATIENT 5 OF 12 ((B)(6))- MFR 3010617000-2018-00187, PATIENT 6 OF 12 ((B)(6))- MFR 3010617000-2018-00

  Patient problems: Thrombosis

  MAUDE report 7277450 ↗
• DeathFeb 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE JOURNAL ARTICLE "ENDOVASCULAR COOLING VERSUS STANDARD FEMORAL CATHETERS AND INTRAVASCULAR COMPLICATIONS: A PROPENSITY-MATCHED COHORT STUDY," THAT FOUR (4) PATIENTS IN THE TARGETED TEMPERATURE MANAGEMENT (TTM) GROUP PRESENTED MAJOR COMPLICATIONS. THIS REPORT IS 4 OF 4. ON AN UNSPECIFIED DATE BETWEEN AUGUST 2012 AND NOVEMBER 2014, A COOLGARD CATHETER WAS PLACED IN PATIENT'S FEMORAL VEIN. THE PATIENT SUFFERED FROM SYMPTOMATIC PULMONARY EMBOLI. AN UNSPECIFIED TIME LATER, THE PATIENT EXPIRED AFTER CEREBRAL HAEMORRHAGE SECONDARY TO INTRAVENOUS THROMBOLYSIS. THE CATHETER DWELL TIME WAS 4.2 DAYS. IN THE CLINICAL STUDY, THE PHYSICIAN INDICATED THAT THE CATHETERIZATION TIME WAS LONGER THAN RECOMMENDED FOR THE TTM PERIOD FOR COOLGARD CATHETER. THE SPECIFIC CATHETER USED IN THE STUDY HAS NOT BEEN REPORTED TO ZOLL. AS DEFAULT, THE COOL LINE CATHETER WAS SELECTED. PATIENT 1 OF 4 ((B)(4))- MFR 3010617000-2018-00176. PATIENT 2 OF 4 ((B)(4))- MFR 3010617000-2018-00180. PATIENT 3 OF 4 ((B)(4))- MFR 3010617000-2018-00181.

  Patient problems: Hemorrhage, Cerebral; Pulmonary Embolism; Thrombosis

  MAUDE report 7277448 ↗
• DeathFeb 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE JOURNAL ARTICLE "ENDOVASCULAR COOLING VERSUS STANDARD FEMORAL CATHETERS AND INTRAVASCULAR COMPLICATIONS: A PROPENSITY-MATCHED COHORT STUDY," THAT FOUR (4) PATIENTS IN THE TARGETED TEMPERATURE MANAGEMENT (TTM) GROUP PRESENTED MAJOR COMPLICATIONS. THIS REPORT IS 3 OF 4. ON AN UNSPECIFIED DATE BETWEEN AUGUST 2012 AND NOVEMBER 2014, A COOLGARD CATHETER WAS PLACED IN PATIENT'S FEMORAL VEIN. THE PATIENT SUFFERED FROM SYMPTOMATIC PULMONARY EMBOLI. AN UNSPECIFIED TIME LATER, THE PATIENT EXPIRED FROM REFRACTORY CARDIOGENIC SHOCK. THE CATHETER DWELL TIME WAS 4.2 DAYS. IN THE CLINICAL STUDY, THE PHYSICIAN INDICATED THAT THE CATHETERIZATION TIME WAS LONGER THAN RECOMMENDED FOR THE TTM PERIOD FOR COOLGARD CATHETER. THE SPECIFIC CATHETER USED IN THE STUDY HAS NOT BEEN REPORTED TO ZOLL. AS DEFAULT, THE COOL LINE CATHETER WAS SELECTED. PATIENT 1 OF 4 ((B)(4))- MFR 3010617000-2018-00176. PATIENT 2 OF 4 ((B)(4))- MFR 3010617000-2018-00180. PATIENT 4 OF 4 ((B)(4)- MFR 3010617000-2018-00182.

  Patient problems: Cardiogenic Shock; Pulmonary Embolism

  MAUDE report 7277447 ↗
• InjuryFeb 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE JOURNAL ARTICLE "ENDOVASCULAR COOLING VERSUS STANDARD FEMORAL CATHETERS AND INTRAVASCULAR COMPLICATIONS: A PROPENSITY-MATCHED COHORT STUDY," THAT TWELVE (12) PATIENTS IN THE TARGETED TEMPERATURE MANAGEMENT (TTM) GROUP PRESENTED MAJOR COMPLICATIONS. THIS REPORT IS 9 OF 12. ON AN UNSPECIFIED DATE BETWEEN AUGUST 2012 AND NOVEMBER 2014, A COOLGARD CATHETER WAS PLACED IN PATIENT'S FEMORAL VEIN. THE PATIENT WAS FOUND TO HAVE THROMBOTIC COMPLICATIONS DURING COOLING. ACCORDING TO THE PHYSICIAN, THE PATIENT DID NOT HAVE A CATHETER-RELATED BLOODSTREAM INFECTION. THE CATHETER DWELL TIME WAS 4.2 DAYS. IN THE CLINICAL STUDY, THE PHYSICIAN INDICATED THAT THE CATHERTERIZATION TIME WAS LONGER THAN RECOMMENDED FOR THE TTM PERIOD FOR COOLGARD CATHETER. THE SPECIFIC CATHETER USED IN THE STUDY HAS NOT BEEN REPORTED TO ZOLL. AS DEFAULT, THE COOL LINE CATHETER WAS SELECTED. PATIENT 1 OF 12 ((B)(6))- MFR 3010617000-2018-00183, PATIENT 2 OF 12 ((B)(6))- MFR 3010617000-2018-00184, PATIENT 3 OF 12 ((B)(6))- MFR 3010617000-2018-00185, PATIENT 4 OF 12 ((B)(6))- MFR 3010617000-2018-00186, PATIENT 5 OF 12 ((B)(6))- MFR 3010617000-2018-00187, PATIENT 6 OF 12 ((B)(6))- MFR 3010617000-2018-0

  Patient problems: Thrombosis

  MAUDE report 7277446 ↗
• InjuryFeb 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE JOURNAL ARTICLE "ENDOVASCULAR COOLING VERSUS STANDARD FEMORAL CATHETERS AND INTRAVASCULAR COMPLICATIONS: A PROPENSITY-MATCHED COHORT STUDY," THAT FOUR (4) PATIENTS IN THE TARGETED TEMPERATURE MANAGEMENT (TTM) GROUP PRESENTED MAJOR COMPLICATIONS. THIS REPORT IS 1 OF 4. ON AN UNSPECIFIED DATE BETWEEN (B)(6) 2012 AND (B)(6) 2014, A COOLGARD CATHETER WAS PLACED IN PATIENT'S FEMORAL VEIN. HAEMORRHAGIC SHOCK COMPLICATED THE CATHETER INSERTION. THE CATHETER DWELL TIME WAS 4.2 DAYS. IN THE CLINICAL STUDY, THE PHYSICIAN INDICATED THAT THE CATHERTERIZATION TIME WAS LONGER THAN RECOMMENDED FOR THE TTM PERIOD FOR COOLGARD CATHETER. THE SPECIFIC CATHETER USED IN THE STUDY HAS NOT BEEN REPORTED TO ZOLL. AS DEFAULT, THE COOL LINE CATHETER WAS SELECTED. PATIENT 2 OF 4 (CCR 38934)- MFR 3010617000-2018-00180, PATIENT 3 OF 4 (CCR 38935)- MFR 3010617000-2018-00181, PATIENT 4 OF 4 (CCR 38936)- MFR 3010617000-2018-00182.

  Patient problems: Shock

  MAUDE report 7277443 ↗
• InjuryFeb 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE JOURNAL ARTICLE "ENDOVASCULAR COOLING VERSUS STANDARD FEMORAL CATHETERS AND INTRAVASCULAR COMPLICATIONS: A PROPENSITY-MATCHED COHORT STUDY," THAT TWELVE (12) PATIENTS IN THE TARGETED TEMPERATURE MANAGEMENT (TTM) GROUP PRESENTED MAJOR COMPLICATIONS. THIS REPORT IS 10 OF 12. ON AN UNSPECIFIED DATE BETWEEN (B)(6) 2012 AND (B)(6) 2014, A COOLGARD CATHETER WAS PLACED IN PATIENT'S FEMORAL VEIN. THE PATIENT WAS FOUND TO HAVE THROMBOTIC COMPLICATIONS IN COOLING. ACCORDING TO THE PHYSICIAN, THE PATIENT DID NOT HAVE A CATHETER-RELATED BLOODSTREAM INFECTION. THE CATHETER DWELL TIME WAS 4.2 DAYS. IN THE CLINICAL STUDY, THE PHYSICIAN INDICATED THAT THE CATHETERIZATION TIME WAS LONGER THAN RECOMMENDED FOR THE TTM PERIOD FOR COOLGARD CATHETER. THE SPECIFIC CATHETER USED IN THE STUDY HAS NOT BEEN REPORTED TO ZOLL. AS DEFAULT, THE COOL LINE CATHETER WAS SELECTED. PATIENT 1 OF 12 ((B)(4)) - MFR 3010617000-2018-00183, PATIENT 2 OF 12 ((B)(4)) - MFR 3010617000-2018-00184, PATIENT 3 OF 12 ((B)(4)) - MFR 3010617000-2018-00185, PATIENT 4 OF 12 ((B)(4)) - MFR 3010617000-2018-00186, PATIENT 5 OF 12 ((B)(4)) - MFR 3010617000-2018-00187, PATIENT 6 OF 12 ((B)(4)) - MFR 3010617000-2018-0

  Patient problems: Thrombosis

  MAUDE report 7277441 ↗
• InjuryFeb 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE JOURNAL ARTICLE "ENDOVASCULAR COOLING VERSUS STANDARD FEMORAL CATHETERS AND INTRAVASCULAR COMPLICATIONS: A PROPENSITY-MATCHED COHORT STUDY," THAT FOUR (4) PATIENTS IN THE TARGETED TEMPERATURE MANAGEMENT (TTM) GROUP PRESENTED MAJOR COMPLICATIONS. THIS REPORT IS 2 OF 4. ON AN UNSPECIFIED DATE BETWEEN AUGUST 2012 AND NOVEMBER 2014, A COOLGARD CATHETER WAS PLACED IN PATIENT'S FEMORAL VEIN. THE PATIENT SUFFERED FROM SYMPTOMATIC PULMONARY EMBOLI. THE PATIENT SURVIVED FOLLOWING SEVERE ACUTE RESPIRATORY DISTRESS. THE CATHETER DWELL TIME WAS 4.2 DAYS. IN THE CLINICAL STUDY, THE PHYSICIAN INDICATED THAT THE CATHETERIZATION TIME WAS LONGER THAN RECOMMENDED FOR THE TTM PERIOD FOR COOLGARD CATHETER. THE SPECIFIC CATHETER USED IN THE STUDY HAS NOT BEEN REPORTED TO ZOLL. AS DEFAULT, THE COOL LINE CATHETER WAS SELECTED. PATIENT 1 OF 4 ((B)(4)) MFR 3010617000-2018-00176, PATIENT 3 OF 4 ((B)(4)) MFR 3010617000-2018-00181, PATIENT 4 OF 4 ((B)(4)) MFR 3010617000-2018-00182.

  Patient problems: Pulmonary Embolism; Respiratory Distress

  MAUDE report 7277435 ↗
• InjuryFeb 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE JOURNAL ARTICLE "ENDOVASCULAR COOLING VERSUS STANDARD FEMORAL CATHETERS AND INTRAVASCULAR COMPLICATIONS: A PROPENSITY-MATCHED COHORT STUDY," THAT TWELVE (12) PATIENTS IN THE TARGETED TEMPERATURE MANAGEMENT (TTM) GROUP PRESENTED MAJOR COMPLICATIONS. THIS REPORT IS 12 OF 12. ON AN UNSPECIFIED DATE BETWEEN (B)(6) 2012 AND (B)(6) 2014, A COOLGARD CATHETER WAS PLACED IN PATIENT'S FEMORAL VEIN. THE PATIENT WAS FOUND TO HAVE THROMBOTIC COMPLICATIONS DURING COOLING. ACCORDING TO THE PHYSICIAN, THE PATIENT DID NOT HAVE A CATHETER-RELATED BLOODSTREAM INFECTION. THE CATHETER DWELL TIME WAS 4.2 DAYS. IN THE CLINICAL STUDY, THE PHYSICIAN INDICATED THAT THE CATHETERIZATION TIME WAS LONGER THAN RECOMMENDED FOR THE TTM PERIOD FOR COOLGARD CATHETER. THE SPECIFIC CATHETER USED IN THE STUDY HAS NOT BEEN REPORTED TO ZOLL. AS DEFAULT, THE COOL LINE CATHETER WAS SELECTED. PATIENT 1 OF 12 ((B)(4)) - MFR 3010617000-2018-00183, PATIENT 2 OF 12 ((B)(4)) - MFR 3010617000-2018-00184, PATIENT 3 OF 12 ((B)(4)) - MFR 3010617000-2018-00185, PATIENT 4 OF 12 ((B)(4)) - MFR 3010617000-2018-00186, PATIENT 5 OF 12 ((B)(4)) - MFR 3010617000-2018-00187, PATIENT 6 OF 12 ((B)(4)) - MFR 3010617000-20

  Patient problems: Thrombosis

  MAUDE report 7275563 ↗
• InjuryFeb 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE JOURNAL ARTICLE "ENDOVASCULAR COOLING VERSUS STANDARD FEMORAL CATHETERS AND INTRAVASCULAR COMPLICATIONS: A PROPENSITY-MATCHED COHORT STUDY," THAT TWELVE (12) PATIENTS IN THE TARGETED TEMPERATURE MANAGEMENT (TTM) GROUP PRESENTED MAJOR COMPLICATIONS. THIS REPORT IS 11 OF 12. ON AN UNSPECIFIED DATE BETWEEN (B)(6) 2012 AND (B)(6) 2014, A COOLGARD CATHETER WAS PLACED IN PATIENT'S FEMORAL VEIN. THE PATIENT WAS FOUND TO HAVE THROMBOTIC COMPLICATIONS DURING COOLING. ACCORDING TO THE PHYSICIAN, THE PATIENT DID NOT HAVE A CATHETER-RELATED BLOODSTREAM INFECTION. THE CATHETER DWELL TIME WAS 4.2 DAYS. IN THE CLINICAL STUDY, THE PHYSICIAN INDICATED THAT THE CATHETERIZATION TIME WAS LONGER THAN RECOMMENDED FOR THE TTM PERIOD FOR COOLGARD CATHETER. THE SPECIFIC CATHETER USED IN THE STUDY HAS NOT BEEN REPORTED TO ZOLL. AS DEFAULT, THE COOL LINE CATHETER WAS SELECTED. PATIENT 1 OF 12 ((B)(4))- MFR 3010617000-2018-00183. PATIENT 2 OF 12 ((B)(4))- MFR 3010617000-2018-00184. PATIENT 3 OF 12 ((B)(4))- MFR 3010617000-2018-00185. PATIENT 4 OF 12 ((B)(4))- MFR 3010617000-2018-00186. PATIENT 5 OF 12 ((B)(4))- MFR 3010617000-2018-00187. PATIENT 6 OF 12 ((B)(4))- MFR 3010617000-2018-001

  Patient problems: Thrombosis

  MAUDE report 7275560 ↗
• InjuryFeb 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE JOURNAL ARTICLE "ENDOVASCULAR COOLING VERSUS STANDARD FEMORAL CATHETERS AND INTRAVASCULAR COMPLICATIONS: A PROPENSITY-MATCHED COHORT STUDY," THAT TWELVE (12) PATIENTS IN THE TARGETED TEMPERATURE MANAGEMENT (TTM) GROUP PRESENTED MAJOR COMPLICATIONS. THIS REPORT IS 2 OF 12. ON AN UNSPECIFIED DATE BETWEEN AUGUST 2012 AND NOVEMBER 2014, A COOLGARD CATHETER WAS PLACED IN PATIENT'S FEMORAL VEIN. THE PATIENT WAS FOUND TO HAVE THROMBOTIC COMPLICATIONS DURING COOLING. ACCORDING TO THE PHYSICIAN, THE PATIENT DID NOT HAVE A CATHETER-RELATED BLOODSTREAM INFECTION. THE CATHETER DWELL TIME WAS 4.2 DAYS. IN THE CLINICAL STUDY, THE PHYSICIAN INDICATED THAT THE CATHETERIZATION TIME WAS LONGER THAN RECOMMENDED FOR THE TTM PERIOD FOR COOLGARD CATHETER. THE SPECIFIC CATHETER USED IN THE STUDY HAS NOT BEEN REPORTED TO ZOLL. AS DEFAULT, THE COOL LINE CATHETER WAS SELECTED. PATIENT 1 OF 12 (B)(6)- MFR 3010617000-2018-00183. PATIENT 3 OF 12 (B)(6)- MFR 3010617000-2018-00185. PATIENT 4 OF 12 (B)(6)- MFR 3010617000-2018-00186. PATIENT 5 OF 12 (B)(6)- MFR 3010617000-2018-00187. PATIENT 6 OF 12 (B)(6)- MFR 3010617000-2018-00188. PATIENT 7 OF 12 (B)(6)- MFR 3010617000-2018-00189. PATIENT

  Patient problems: Thrombosis

  MAUDE report 7275559 ↗
• InjuryFeb 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE JOURNAL ARTICLE "ENDOVASCULAR COOLING VERSUS STANDARD FEMORAL CATHETERS AND INTRAVASCULAR COMPLICATIONS: A (B)(6) STUDY," THAT TWELVE (12) PATIENTS IN THE TARGETED TEMPERATURE MANAGEMENT (TTM) GROUP PRESENTED MAJOR COMPLICATIONS. THIS REPORT IS 3 OF 12. ON AN UNSPECIFIED DATE BETWEEN (B)(6) 2012 AND (B)(6) 2014, A COOLGARD CATHETER WAS PLACED IN PATIENT'S FEMORAL VEIN. THE PATIENT WAS FOUND TO HAVE THROMBOTIC COMPLICATIONS DURING COOLING. ACCORDING TO THE PHYSICIAN, THE PATIENT DID NOT HAVE A CATHETER-RELATED BLOODSTREAM INFECTION. THE CATHETER DWELL TIME WAS 4.2 DAYS. IN THE CLINICAL STUDY, THE PHYSICIAN INDICATED THAT THE CATHETERIZATION TIME WAS LONGER THAN RECOMMENDED FOR THE TTM PERIOD FOR COOLGARD CATHETER. THE SPECIFIC CATHETER USED IN THE STUDY HAS NOT BEEN REPORTED TO ZOLL. AS DEFAULT, THE COOL LINE CATHETER WAS SELECTED. PATIENT 1 OF 12 ((B)(4)) - MFR 3010617000-2018-00183, PATIENT 2 OF 12 ((B)(4)) - MFR 3010617000-2018-00184, PATIENT 4 OF 12 ((B)(4)) - MFR 3010617000-2018-00186, PATIENT 5 OF 12 ((B)(4)) - MFR 3010617000-2018-00187, PATIENT 6 OF 12 ((B)(4)) - MFR 3010617000-2018-00188, PATIENT 7 OF 12 ((B)(4)) - MFR 3010617000-2018-00189, PATIENT 8

  Patient problems: Thrombosis

  MAUDE report 7275558 ↗
• InjuryFeb 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE JOURNAL ARTICLE "ENDOVASCULAR COOLING VERSUS STANDARD FEMORAL CATHETERS AND INTRAVASCULAR COMPLICATIONS: A PROPENSITY-MATCHED COHORT STUDY," THAT TWELVE (12) PATIENTS IN THE TARGETED TEMPERATURE MANAGEMENT (TTM) GROUP PRESENTED MAJOR COMPLICATIONS. THIS REPORT IS 5 OF 12. ON AN UNSPECIFIED DATE BETWEEN AUGUST 2012 AND NOVEMBER 2014, A COOLGARD CATHETER WAS PLACED IN PATIENT'S FEMORAL VEIN. THE PATIENT WAS FOUND TO HAVE THROMBOTIC COMPLICATIONS DURING COOLING. ACCORDING TO THE PHYSICIAN, THE PATIENT DID NOT HAVE A CATHETER-RELATED BLOODSTREAM INFECTION. THE CATHETER DWELL TIME WAS 4.2 DAYS. IN THE CLINICAL STUDY, THE PHYSICIAN INDICATED THAT THE CATHERTERIZATION TIME WAS LONGER THAN RECOMMENDED FOR THE TTM PERIOD FOR COOLGARD CATHETER. THE SPECIFIC CATHETER USED IN THE STUDY HAS NOT BEEN REPORTED TO ZOLL. AS DEFAULT, THE COOL LINE CATHETER WAS SELECTED. PATIENT 1 OF 12 ((B)(6))- MFR 3010617000-2018-00183, PATIENT 2 OF 12 ((B)(6))- MFR 3010617000-2018-00184, PATIENT 3 OF 12 ((B)(6))- MFR 3010617000-2018-00185, PATIENT 4 OF 12 ((B)(6))- MFR 3010617000-2018-00186, PATIENT 6 OF 12 ((B)(6))- MFR 3010617000-2018-00188, PATIENT 7 OF 12 ((B)(6))- MFR 3010617000-2018-0

  Patient problems: Thrombosis

  MAUDE report 7275557 ↗
• InjuryFeb 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE JOURNAL ARTICLE "ENDOVASCULAR COOLING VERSUS STANDARD FEMORAL CATHETERS AND INTRAVASCULAR COMPLICATIONS: A PROPENSITY-MATCHED COHORT STUDY," THAT TWELVE (12) PATIENTS IN THE TARGETED TEMPERATURE MANAGEMENT (TTM) GROUP PRESENTED MAJOR COMPLICATIONS. THIS REPORT IS 6 OF 12. ON AN UNSPECIFIED DATE BETWEEN AUGUST 2012 AND NOVEMBER 2014, A COOLGARD CATHETER WAS PLACED IN PATIENT'S FEMORAL VEIN. THE PATIENT WAS FOUND TO HAVE THROMBOTIC COMPLICATIONS DURING COOLING. ACCORDING TO THE PHYSICIAN, THE PATIENT DID NOT HAVE A CATHETER-RELATED BLOODSTREAM INFECTION. THE CATHETER DWELL TIME WAS 4.2 DAYS. IN THE CLINICAL STUDY, THE PHYSICIAN INDICATED THAT THE CATHETERIZATION TIME WAS LONGER THAN RECOMMENDED FOR THE TTM PERIOD FOR COOLGARD CATHETER. THE SPECIFIC CATHETER USED IN THE STUDY HAS NOT BEEN REPORTED TO ZOLL. AS DEFAULT, THE COOL LINE CATHETER WAS SELECTED. PATIENT 1 OF 12 ((B)(4))- MFR 3010617000-2018-00183; PATIENT 2 OF 12 ((B)(4))- MFR 3010617000-2018-00184; PATIENT 3 OF 12 ((B)(4))- MFR 3010617000-2018-00185; PATIENT 4 OF 12 ((B)(4))- MFR 3010617000-2018-00186; PATIENT 5 OF 12 ((B)(4))- MFR 3010617000-2018-00187; PATIENT 7 OF 12 ((B)(4))- MFR 3010617000-2018-00

  Patient problems: Thrombosis

  MAUDE report 7275556 ↗
• InjuryFeb 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE JOURNAL ARTICLE "ENDOVASCULAR COOLING VERSUS STANDARD FEMORAL CATHETERS AND INTRAVASCULAR COMPLICATIONS: A PROPENSITY-MATCHED COHORT STUDY," THAT TWELVE (12) PATIENTS IN THE TARGETED TEMPERATURE MANAGEMENT (TTM) GROUP PRESENTED MAJOR COMPLICATIONS. THIS REPORT IS 4 OF 12. ON AN UNSPECIFIED DATE BETWEEN AUGUST 2012 AND NOVEMBER 2014, A COOLGARD CATHETER WAS PLACED IN PATIENT'S FEMORAL VEIN. THE PATIENT WAS FOUND TO HAVE THROMBOTIC COMPLICATIONS DURING COOLING. ACCORDING TO THE PHYSICIAN, THE PATIENT DID NOT HAVE A CATHETER-RELATED BLOODSTREAM INFECTION. THE CATHETER DWELL TIME WAS 4.2 DAYS. IN THE CLINICAL STUDY, THE PHYSICIAN INDICATED THAT THE CATHERTERIZATION TIME WAS LONGER THAN RECOMMENDED FOR THE TTM PERIOD FOR COOLGARD CATHETER. THE SPECIFIC CATHETER USED IN THE STUDY HAS NOT BEEN REPORTED TO ZOLL. AS DEFAULT, THE COOL LINE CATHETER WAS SELECTED. PATIENT 1 OF 12 (B)(6)- MFR 3010617000-2018-00183, PATIENT 2 OF 12 (B)(6)- MFR 3010617000-2018-00184, PATIENT 3 OF 12 (B)(6)- MFR 3010617000-2018-00185, PATIENT 5 OF 12 (B)(6)- MFR 3010617000-2018-00187, PATIENT 6 OF 12 (B)(6)- MFR 3010617000-2018-00188, PATIENT 7 OF 12 (B)(6)- MFR 3010617000-2018-00189, PATIEN

  Patient problems: Thrombosis

  MAUDE report 7275555 ↗
• InjuryFeb 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE JOURNAL ARTICLE "ENDOVASCULAR COOLING VERSUS STANDARD FEMORAL CATHETERS AND INTRAVASCULAR COMPLICATIONS: A PROPENSITY-MATCHED COHORT STUDY," THAT TWELVE (12) PATIENTS IN THE TARGETED TEMPERATURE MANAGEMENT (TTM) GROUP PRESENTED MAJOR COMPLICATIONS. THIS REPORT IS 1 OF 12. ON AN UNSPECIFIED DATE BETWEEN (B)(6) 2012 AND (B)(6) 2014, A COOLGARD CATHETER WAS PLACED IN PATIENT'S FEMORAL VEIN. THE PATIENT WAS FOUND TO HAVE THROMBOTIC COMPLICATIONS DURING COOLING. ACCORDING TO THE PHYSICIAN, THE PATIENT DID NOT HAVE A CATHETER-RELATED BLOODSTREAM INFECTION. THE CATHETER DWELL TIME WAS 4.2 DAYS. IN THE CLINICAL STUDY, THE PHYSICIAN INDICATED THAT THE CATHETERIZATION TIME WAS LONGER THAN RECOMMENDED FOR THE TTM PERIOD FOR COOLGARD CATHETER. THE SPECIFIC CATHETER USED IN THE STUDY HAS NOT BEEN REPORTED TO ZOLL. AS DEFAULT, THE COOL LINE CATHETER WAS SELECTED. PATIENT 2 OF 12 (CCR (B)(6))- MFR 3010617000-2018-00184. PATIENT 3 OF 12 (CCR (B)(6))- MFR 3010617000-2018-00185. PATIENT 4 OF 12 (CCR (B)(6))- MFR 3010617000-2018-00186. PATIENT 5 OF 12 (CCR (B)(6))- MFR 3010617000-2018-00187. PATIENT 6 OF 12 (CCR (B)(6))- MFR 3010617000-2018-00188. PATIENT 7 OF 12 (CCR (B)(6))-

  Patient problems: Thrombosis

  MAUDE report 7275554 ↗