Arctic Front Advance™ 2AF284 (UDI 00763000341480)Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00763000341480), received between Jan 7, 2021 and Nov 6, 2024 — classified as 13 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (18 reports).

1 other recall cover devices cleared under the same FDA submission (P100010); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE TEMPERATURES WERE DROPPING FASTER THAN EXPECTED. THE ELECTRICAL UMBILICAL CABLE WAS REPLACED WITHOUT RESOLUTION. A BACKUP CONSOLE WAS THEN PUT INTO USE WITH A NEW AUTO CONNECTION BOX, BUT THE CATHETER HAD TO BE REPLACED BECAUSE THE DATE AND TIME ON THE CONSOLE WAS INCORRECT. THE BALLOON CATHETER, ELECTRICAL UMBILICAL CABLE AND AUTO CONNECTION BOX WERE REPLACED TO RESOLVE THE ISSUES. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20623161 ↗
• MalfunctionNov 4, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE TEMPERATURES DROPPED FASTER THAN EXPECTED ON ALL ABLATIONS. THE CONSOLE WAS REBOOTED AND THE ISSUE REMAINED. THE AUTO CONNECTION BOX WAS REPLACED WHICH DID NOT RESOLVE THE ISSUE. THE BALLOON CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. THE DATA FILES WERE REVIEWED AND TEMPERATURE OSCILLATIONS WERE OBSERVED. AFTER THE PROCEDURE, TEST ABLATIONS WERE PERFORMED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20600828 ↗
• MalfunctionOct 17, 2024Leak/Splash; Excessive Cooling; Infusion or Flow Problem; Protective Measures Problem; Leak/Splash; Excessive Cooling; Infusion or Flow Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE FLOW WAS HIGHER THAN EXPECTED, THERE WERE TEMPERATURE OVERSHOOTS, AND FROST FORMING ON THE COAXIAL CONNECTION. IT WAS ALSO REPORTED THAT A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE VACUUM WAS DISABLED DUE TO A PROBLEM WITH THE COAXIAL UMBILICAL CABLE. THE BALLOON CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20473230 ↗
• MalfunctionOct 16, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, TEMPERATURE FLUCTUATIONS WHERE OBSERVED DURING ABLATIONS. THE TEMPERATURES QUICKLY BECAME VERY COLD. IT WAS CONFIRMED BY FLUOROSCOPY AND INTRACARDIAC ECHOCARDIOGRAPHY (ICE) THAT THEY WERE NOT DEEP INSIDE THE VEIN. THE ELECTRICAL UMBILICAL CABLE AND COAXIAL UMBILICAL CABLE WERE REPLACED WHICH DID NOT RESOLVE THE ISSUE. THE BALLOON CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20468013 ↗
• MalfunctionOct 16, 2024Use of Device Problem; Excessive Cooling; Use of Device Problem; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE TEMPERATURE WAS NOT AS EXPECTED SO THE PHYSICIAN STOPPED THE ABLATIONS EARLY FOR PATIENT SAFETY. POST MAPPING WAS PERFORMED USING ANOTHER MANUFACTURER'S DEVICE. THERE WAS MINIMAL EVIDENCE OF ANY ABLATIONS HAVING BEEN DONE, AND EACH OF THE VEINS STILL HAD LOCAL PULMONARY VEIN SIGNALS. A TEST ABLATION WAS PERFORMED IN A STERILE BOWL OF SALINE. THE CONSOLE TEMPERATURES SHOWED VERY RAPID COOLING. THE ICE CAP ON TOP OF THE BALLOON WAS INCONSISTENT AND PART OF THE EXPECTED ICE CAP AREA HAD LITTLE TO NO ICE. THE BALLOON CATHETER WAS REPLACED WITH ANOTHER MODEL BALLOON CATHETER WHICH RESOLVED THE ISSUE. ALL OF THE ABLATIONS WERE REPEATED. THE TEMPERATURE WAS AS EXPECTED. POST MAPPING WAS PERFORMED AGAIN AND IT SHOWED COMPLETE PULMONARY VEIN AND POSTERIOR WALL ISOLATION. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20463795 ↗
• MalfunctionOct 16, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE TEMPERATURES WERE COLDER THAN EXPECTED AND THE TEMPERATURES DROPPED FASTER THAN EXPECTED WITHIN FIFTY SECONDS. THE ELECTRICAL UMBILICAL CABLE WAS REPLACED WITHOUT RESOLUTION. SUBSEQUENTLY, THE BALLOON CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20462613 ↗
• MalfunctionOct 15, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE TEMPERATURE CURVE DROPPED MORE QUICKLY THAN EXPECTED. THE AUTO CONNECTION BOX WAS REPLACED WITHOUT RESOLUTION. IT WAS SUGGESTED TO REPLACED THE ELECTRICAL UMBILICAL CABLE, BUT THE PHYSICIAN DECLINED. DESPITE THE ISSUE, THE CASE WAS COMPLETED WITH CRYO. THE DATA FILES WERE LATER REVIEWED AND TEMPERATURE FLUCTUATIONS WERE OBSERVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453089 ↗
• MalfunctionOct 15, 2024Excessive Cooling; Insufficient Device Problem Information; Excessive Cooling; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, TEMPERATURES WERE FLUCTUATING UNEXPECTEDLY DURING ABLATIONS AND WOULD GET ABNORMALLY COLDER MORE QUICKLY THAN EXPECTED. THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT AND A TEST FREEZE WAS PERFORMED. DURING THE TEST FREEZE, IT APPEARED THAT ONLY ONE SIDE OF THE BALLOON CATHETER WAS DEVELOPING ICE FORMATION. IT WAS SUSPECTED THAT A COOLANT JET MAY HAVE BEEN CLOGGED. DESPITE THE ISSUES, THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20451690 ↗
• MalfunctionOct 15, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE TEMPERATURES WERE NOT AS EXPECTED. IT WAS NOTED THAT THE TEMPERATURES DURING ABLATION BECAME VERY COLD ALMOST IMMEDIATELY. THE PHYSICIAN HAD TO CUT ALL THE ABLATIONS SHORT DUE TO THE COLD TEMPERATURES. ALL PULMONARY VEINS WERE ISOLATED, AND THE BALLOON CATHETER WAS NOT REPLACED. THE CASE WAS COMPLETED WITH CRYO. THE DATA FILES WERE REVIEWED AFTER THE CASE AND SLIGHT TEMPERATURE FLUCTUATIONS WERE OBSERVED IN SOME OF THE ABLATIONS., OVERALL THE CONSOLE CONTROLLED THE PRESSURE AND FLOW AS EXPECTED. IT WAS SURMISED THAT THE TEMPERATURE FLUCTUATIONS COULD HAVE BEEN DUE TO EXTERNAL INTERFERENCE OR RELATED TO A CONSUMABLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20451323 ↗
• MalfunctionOct 14, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, DURING THE FIRST FREEZE THE TEMPERATURE DROPPED UNEXPECTEDLY. THERAPY WAS STOPPED AND IMAGING THEN CONFIRMED THAT THE BALLOON CATHETER WAS OUTSIDE THE VEIN AND ROUND IN SHAPE. THE SECOND FREEZE WAS THEN ABORTED. THE ELECTRICAL UMBILICAL CABLE WAS REPLACED WITHOUT RESOLVE. THE BALLOON CATHETER WAS THEN REPLACED TO RESOLVE THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441137 ↗
• MalfunctionOct 11, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE TEMPERATURE DROPPED FASTER AND COLDER THEN EXPECTED. THE BALLOON CATHETER WAS REPLACED TO RESOLVE THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20428301 ↗
• MalfunctionMar 21, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SYSTEM DID NOT RECOGNIZE THE CATHETER. THE ELECTRICAL UMBILICAL CABLE WAS RECONNECTED WITHOUT RESOLVE. THE ELECTRICAL UMBILICAL CABLE WAS REPLACED WITHOUT RESOLVE. THE BALLOON CATHETER DEFLATED AND THE SYSTEM INTEGRITY TEST / SYSTEM FLUSH WAS REATTEMPTED. AFTER A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A COMPROMISED OUTER VACUUM. THE BALLOON CATHETER WAS REPLACED TO RESOLVE THE ISSUE. THE NEW BALLOON CATHETER WAS INSERTED INTO THE PATIENT AND A KINK WAS OBSERVED VIA IMAGING. THE BALLOON CATHETER WAS THEN REPLACED TO RESOLVE THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18953889 ↗
• MalfunctionMar 18, 2024Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE LOW PRESSURE REGULATOR (LPR) WAS HIGHER THAN EXPECTED AND A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE BALLOON WAS DEFLATED. THE CONSOLE WAS VENTED WITHOUT RESOLUTION. THE COAXIAL UMBILICAL CABLE WAS REPLACED WITHOUT RESOLUTION. THE CONSOLE WAS VENTED AGAIN WITHOUT RESOLUTION. THE BALLOON CATHETER WAS ALSO REPLACED WITHOUT RESOLUTION. RAPID INFLATION AND DEFLATION WERE INITIATED WITHOUT RESOLUTION. IT WAS ALSO REPORTED THAT THE BALLOON CATHETER IN USE WAS EXPIRED. THE CASE WAS COMPLETED AND SWITCHED TO RADIOFREQUENCY. THE OUTCOME OF THIS CASE IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN R EPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18920488 ↗
• MalfunctionFeb 7, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A KINK WAS OBSERVED IN THE BALLOON PORTION OF THE BALLOON CATHETER. THE BALLOON CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664032 ↗
• InjuryDec 11, 2023Leak/Splash; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Temperature Problem; Leak/Splash; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE TEMPERATURES DROPPED FASTER THAN EXPECTED AND THE MAXIMUM FLOW WAS REACHED EARLIER THAN EXPECTED; THE PRESSURES AND FLOW WERE IN THE EXPECTED RANGE. IT WAS FURTHER REPORTED THAT FROST WAS NOTED ON THE COAXIAL UMBILICAL CABLE WHERE IT WAS CONNECTED TO THE BALLOON CATHETER. THE PHYSICIAN ELECTED TO ABORT THE PROCEDURE, AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18305941 ↗
• MalfunctionNov 13, 2023Material Integrity Problem; Temperature Problem; Material Integrity Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE TEMPERATURE READINGS WERE COLDER THAN NORMAL AND TEMPERATURE SPIKES WERE NOTED. IT WAS SUSPECTED THAT THE THERMOCOUPLE OF THE BALLOON CATHETER MAY HAVE BEEN BAD. THE BALLOON CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18121508 ↗
• MalfunctionNov 13, 2023Material Integrity Problem; Material Twisted/Bent; Protective Measures Problem; Material Integrity Problem; Material Twisted/Bent; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. THE ELECTRICAL AND COAXIAL UMBILICAL CABLES WERE RECONNECTED AND THEN REPLACED, BUT THE ISSUE PERSISTED. THE BALLOON CATHETER WAS THEN REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120637 ↗
• MalfunctionOct 19, 2023Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, MULTIPLE SYSTEM NOTICES WERE RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED BLOOD IN THE CATHETER HANDLE, THE INJECTION WAS STOPPED AND THE VACUUM DISABLED. IT WAS NOTED THAT THERE WAS BLOOD ON THE COAXIAL UMBILICAL CABLE AND BALLOON CATHETER SIDE AND NONE IN THE CONSOLE. THE COAXIAL UMBILICAL CABLE AND BALLOON CATHETER WERE REPLACED TO RESOLVE THE ISSUES. THE CASE WAS COMPLETED WITH CRYO. IMAGES AND DATA FILES WERE PROVIDED, PRESSURE AND FLOW WERE AS EXPECTED. TEST INJECTIONS WERE CARRIED OUT AND THE ISSUES WERE NOT REPRODUCED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17963500 ↗
• MalfunctionOct 18, 2023Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CONSOLE AND THE SYSTEM IN INOPERABLE. IT WAS NOTED THAT THERE WAS BLOOD ON THE BALLOON CATHETER CONNECTION. THERE WAS NO BLOOD INSIDE THE COAXIAL PORT OF THE CONSOLE. THE BALLOON CATHETER, COAXIAL UMBILICAL CABLE WERE REPLACED AND THE CONSOLE REBOOTED TO RESOLVE THE SYSTEM NOTICE. INJECTION PRESSURE WAS LOWER THAN EXPECTED. THE CASE WAS COMPLETED WITH CRYO. TEST INJECTIONS WERE LATER CARRIED OUT AND NO ISSUES WERE NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17958107 ↗
• MalfunctionOct 16, 2023Compatibility Problem; Material Integrity Problem; Material Twisted/Bent; Protective Measures Problem; Compatibility Problem; Material Integrity Problem; Material Twisted/Bent; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER WAS UNABLE TO ADVANCE IN THE BALLOON CATHETER AFTER TRANSITIONING TO ANOTHER PULMONARY VEIN (PV). A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. THE MAPPING CATHETER AND BALLOON CATHETER WERE REMOVED AND REPLACED TO RESOLVE THE ISSUE. UPON REMOVAL OF THE MAPPING CATHETER AND BALLOON CATHETER, THE SHEATH APPEARED TWISTED ON THE ULTRASOUND. THE SHEATH WAS REPLACED TO RESOLVE THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940398 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PHRENIC NERVE  ABRUPTLY STOPPED FUNCTIONING. AFTER WAITING APPROXIMATELY TWENTY FIVE MINUTES THE PHRENIC NERVE FUNCTION DID NOT RETURN. THE CASE WAS COMPLETED WITH CRYO. THE PATIENT'S HOSPITALIZATION WAS EXTENDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 17539906 ↗
• MalfunctionAug 9, 2023Protective Measures Problem; Temperature Problem; Protective Measures Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE COAXIAL UMBILICAL CABLE WAS RECONNECTED, WITHOUT RESOLUTION. THE BALLOON CATHETER WAS NOT REACHING THE EXPECTED TEMPERATURE, SO THE SYSTEM INTEGRITY TEST WAS NOT PASSING. THE BALLOON CATHETER WAS REPLACED WHICH RESOLVED THE ISSUES. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494854 ↗
• MalfunctionAug 1, 2023Material Integrity Problem; Material Twisted/Bent; Protective Measures Problem; Material Integrity Problem; Material Twisted/Bent; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. THE CONSOLE WAS REBOOTED TWICE WITHOUT RESOLVE. THE BALLOON CATHETER WAS REPLACED TO RESOLVE THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17436686 ↗
• MalfunctionJul 27, 2023Flushing Problem; Leak/Splash; Flushing Problem; Leak/Splash

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE SHEATH WAS ABLE TO BE ASPIRATED PRIOR TO BALLOON CATHETER INSERTION; HOWEVER, ONCE THE BALLOON CATHETER WAS INSERTED, IT BECAME DIFFICULT TO ASPIRATE AND AIR BUBBLES APPEARED TO BE CREATED WITH A VACUUM EFFECT ON THE SIDE PORT OF THE SHEATH. IT WAS CONFIRMED THAT THE SHEATH WAS NOT KINKED AND THE BALLOON CATHETER WAS RE-PREPPED MULTIPLE TIMES WITHOUT RESOLUTION. ASPIRATION WAS ALSO ATTEMPTED WITH THE BALLOON CATHETER INSIDE THE SHEATH AT DIFFERENT ADVANCEMENTS WITHOUT RESOLUTION. THE BALLOON CATHETER WAS REPLACED WITHOUT RESOLUTION. THE SHEATH WAS REPLACED WITHOUT RESOLUTION. IT WAS ALSO REPORTED THAT UNKNOWN SYSTEM NOTICES WERE RECEIVED AND THE ELECTRICAL UMBILICAL CABLE AND COAXIAL UMBILICAL CABLE WERE RECONNECTED WHICH RESOLVED THOSE ISSUES. DESPITE THE UNRESOLVED ASPIRATION ISSUE, THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17404465 ↗
• MalfunctionJul 27, 2023Flushing Problem; Leak/Splash; Flushing Problem; Leak/Splash

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE SHEATH WAS ABLE TO BE ASPIRATED PRIOR TO BALLOON CATHETER INSERTION; HOWEVER, ONCE THE BALLOON CATHETER WAS INSERTED, IT BECAME DIFFICULT TO ASPIRATE AND AIR BUBBLES APPEARED TO BE CREATED WITH A VACUUM EFFECT ON THE SIDE PORT OF THE SHEATH. IT WAS CONFIRMED THAT THE SHEATH WAS NOT KINKED AND THE BALLOON CATHETER WAS RE-PREPPED MULTIPLE TIMES WITHOUT RESOLUTION. ASPIRATION WAS ALSO ATTEMPTED WITH THE BALLOON CATHETER INSIDE THE SHEATH AT DIFFERENT ADVANCEMENTS WITHOUT RESOLUTION. THE BALLOON CATHETER WAS REPLACED WITHOUT RESOLUTION. THE SHEATH WAS REPLACED WITHOUT RESOLUTION. IT WAS ALSO REPORTED THAT UNKNOWN SYSTEM NOTICES WERE RECEIVED AND THE ELECTRICAL UMBILICAL CABLE AND COAXIAL UMBILICAL CABLE WERE RECONNECTED WHICH RESOLVED THOSE ISSUES. DESPITE THE UNRESOLVED ASPIRATION ISSUE, THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17404457 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100010. One submission often covers many models, so check the product and lot details in each record.

• Z-0149-2012 · Aug 29, 2011 · Terminated
  Medtronic Arctic Front Catheter, Sterile EO, Medtronic CryoCath LP, Kirkland, Quebec, H9H 5 H3, Canada, Model 2AF282 and 2AF231 ( not distributed in US) Product Usage: The Medtr