IcePearl® 2.1 CX 90° Cryoablation Needle FPRPR3601Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 07290104830990), received between Jun 1, 2017 and Nov 4, 2025 — classified as 15 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (22 reports).

2 FDA recall records name this device's identifier.

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.

Recalls naming this device

1. Nov 18, 2020Class IICompleted

   Complaint trend regarding needle shaft gas leaks.

   Z-0660-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jun 4, 2020Class IITerminated

   The needle surface deteriorated due to unexpected electrolysis during procedure.

   Z-2674-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 78 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS THAT PNEUMOTHORAX OCCURRED, REQUIRING AN ADDITIONAL DEVICE. AN ICEPEARL 2.1 CX 90 DEGREE NEEDLE WAS SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT CANCER THAT HAD SPREAD TO THE LUNGS FROM THE COLON. THE ICEPEARL 2.1 CX 90 DEGREE NEEDLE PERFORMED AS EXPECTED DURING THE TESTING PERIOD AND WAS PLACED IN THE PATIENT. UPON PLACEMENT OF SUBSEQUENT UNKNOWN DEVICES, THE PATIENT DEVELOPED A PNEUMOTHORAX, AND A CHEST TUBE WAS PLACED. AFTER THE CHEST TUBE WAS PLACED, THE PHYSICIAN OPTED TO START THE FREEZE CYCLE FOR THE ICEPEARL 2.1 CX 90 DEGREE NEEDLE. DURING THE PROCEDURE, FROST OCCURRED ON THE SHAFT OF THE DEVICE WHERE THE NEEDLE CONNECTS TO THE HANDLE OF THE DEVICE. THE ORIGINAL DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Pneumothorax

  MAUDE report 23470794 ↗
• MalfunctionOct 30, 2025Nonstandard Device; Defective Device; Nonstandard Device; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ICEPEARL 2.1 CX 90 DEGREE NEEDLE WAS CHOSEN FOR A CRYOABLATION PROCEDURE TO TREAT A TUMOR IN THE KIDNEY. DURING THE PROCEDURE, THE PHYSICIAN REQUESTED FOR ACTIVE THAW TO ALLOW FOR REPOSITIONING OF THE ICEFORCE 2.1 CX 90 DEGREE NEEDLE TO IMPROVE TREATMENT OF THE TARGET LESION. THE PHYSICIAN NOTED EXCESSIVE ICE FORMATION IN THE KIDNEY DUE TO EXTENDED STICK FREEZE. THE PHYSICIAN REQUESTED THAT BOTH DEVICES ENGAGE ACTIVE THAW. THIS CAUSED THE ICEFORCE 2.1 CX 90 DEGREE NEEDLE AND ICEPEARL 2.1 CX 90 DEGREE NEEDLE DEVICES TO BECOME DISLODGED FROM THE KIDNEY LESION. THE DESIRED POSITIONING OF THE DEVICES IN THE TARGET AREA OF THE KIDNEY WAS LOST DUE TO THE EXCESSIVE ICE FORMATION. THE CASE WAS NOT COMPLETED AND CANCELLED POST-SEDATION BY THE PHYSICIAN DUE TO LOSS OF ACCESS TO THE TARGET AREA. BLEEDING WAS VISUALIZED IN TWO SCANS CONDUCTED AFTER LOSS OF ACCESS. THE BLEEDING AND THE PATIENT CONDITION WAS STABLE AFTER APPROXIMATELY FIFTEEN MINUTES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23430592 ↗
• InjuryJul 31, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THE PATIENT EXPERIENCED A SKIN BURN. AN ICEPEARL 2.1 CX 90 DEGREE NEEDLE WAS CHOSEN FOR A RENAL CRYOABLATION PROCEDURE TO TREAT A RENAL CELL CARCINOMA. THE TREATMENT WAS COMPLETED AND THE ICEPEARL 2.1 CX 90 DEGREE NEEDLE FUNCTIONED AS EXPECTED. DURING CLOSURE, A STERILE TOWEL WAS REMOVED AND REVEALED A BURN OF AN UNKNOWN DEGREE ON THE PATIENT'S SKIN. THE PHYSICIAN STATED THAT HE HAD PLACED SEVERAL WET STERILE TOWELS ON TOP OF THE ARGON HOSE CONNECTED TO THE ICEPEARL 2.1 CX 90 DEGREE NEEDLE, AND THE ARGON HOSE FROZE THROUGH A STERILE TOWEL COVERING THE PATIENT'S SKIN RESULTING IN THE BURN. FROST ON THE CABLE OF THE DEVICE WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THE PATIENT WAS TREATED FOR THE SKIN BURN DURING RECOVERY; HOWEVER, THE SPECIFIC DETAILS OF POST-PROCEDURE TREATMENT IS UNKNOWN.

  Patient problems: Burn(s)

  MAUDE report 22681312 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERMAL BURNS OCCURRED. AN ICEPEARL 2.1 CX 90 DEGREE NEEDLE WAS SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT RENAL CELL CARCINOMA (RCC) RECURRENCE. THE PATIENT WAS ANESTHETIZED IN PRONE POSITION. TWO CRYOABLATION NEEDLES WERE USED FOR THE ABLATION. AFTER THE PROCEDURE WAS COMPLETED IT WAS NOTED THAT THE ABLATION NEEDLE TUBING HAD COME IN CONTACT WITH THE SKIN DESPITE THE USAGE OF DRAPING TO PROTECT THE SKIN. THERMAL BURNS OCCURRED AS A RESULT.

  Patient problems: Burn(s)

  MAUDE report 22018235 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERMAL BURNS OCCURRED. AN ICEPEARL 2.1 CX 90 DEGREE NEEDLE WAS SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT RENAL CELL CARCINOMA (RCC) RECURRENCE. THE PATIENT WAS ANESTHETIZED IN PRONE POSITION. TWO CRYOABLATION NEEDLES WERE USED FOR THE ABLATION. AFTER THE PROCEDURE WAS COMPLETED, IT WAS NOTED THAT THE ABLATION NEEDLE TUBING HAD COME IN CONTACT WITH THE SKIN DESPITE THE USAGE OF DRAPING TO PROTECT THE SKIN. THERMAL BURNS OCCURRED AS A RESULT.

  Patient problems: Burn(s)

  MAUDE report 22018233 ↗
• MalfunctionMar 29, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED A GAS/AIR LEAK OCCURRED ON THE SHAFT OF THE DEVICE. DURING PREPARATION, AN ICEPEARL 2.1 CX 90 DEGREE NEEDLE WAS REPORTED TO HAVE A GAS/AIR LEAK FROM THE SHAFT OF THE DEVICE, AN AIR BUBBLE WAS PRESENT. TO TROUBLESHOOT THE EVENT THE DEVICE WAS SWITCHED TO ANOTHER CHANNEL, DEVICE WAS NOT USED IN THE PROCEDURE. ANOTHER DEVICE OF A DIFFERENT MODEL WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19005774 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FROST ON THE GAS CABLE, CAUSING A SECOND-DEGREE THERMAL BURN ON THE PATIENT SKIN. A ICEPEARL 2.1 CX 90 DEGREE NEEDLE WAS SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT RENAL CELL CARCINOMA. THE PATIENT WAS PRONE ON THE TABLE DURING THE PROCEDURE, AND THE GAS CABLE WAS LYING ON TOWELS ABOVE THE PATIENT SKIN. DURING THE FREEZE MODE, THE CABLE BECAME VERY COLD, AS IS EXPECTED, SO FROST FORMED ON THE CABLE. SINCE THE TOWELS WERE WET, THE THERMAL ENERGY TRANSFERRED TO THE PATIENT SKIN AND CAUSED A SECOND-DEGREE THERMAL BURN. THE BURN WAS DISCOVERED POST-PROCEDURE. THE ORIGINAL DEVICE WAS USED TO COMPLETE THE PROCEDURE. LOOSE BANDAGES WERE APPLIED TO COVER THE AREA OF THE BURN, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 16460045 ↗
• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SECOND-DEGREE BURN WAS OBSERVED ON THE PATIENT SKIN. AN ICEPEARL 2.1 CX 90 DEGREE NEEDLE WAS USED FOR A RENAL CRYOABLATION PROCEDURE TO TREAT CANCER. NO DEVICE ISSUES WERE REPORTED; HOWEVER, AROUND SIX MINUTES INTO THE FIRST FREEZE, ICE HAD FORMED ON THE TOWEL BETWEEN THE GAS LINE AND THE PATIENT SKIN. THE ICE HAD PASSED TO THE PATIENT SKIN, SO THE TOWEL WAS REMOVED. WARM SALINE, A HEAT PACK, AND EXTRA LAYERS OF TOWELS WERE PLACED UNDER THE LINE TO PROTECT THE SKIN. AFTER COMPLETION OF THE TREATMENT A SKIN BRUISE AND SOME BLISTERS WERE SEEN. THE PATIENT WAS SENT HOME THE SAME DAY AFTER SETTING UP AN APPOINTMENT WITH A DERMATOLOGIST FOR FURTHER OBSERVATION.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 16403757 ↗
• MalfunctionNov 29, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE NEEDLE SHAFT WAS LEAKING GAS. DURING DEVICE PREPARATION FOR THE CRYOABLATION PROCEDURE, THERE WAS A GAS BUBBLE OBSERVED ON THE SHAFT OF THE ICEPEARL 2.1 CX 90 DEGREE NEEDLE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. THE NEEDLE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15880591 ↗
• InjuryAug 16, 2022Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT THE ITHAW AND CAUTERY OPTIONS WERE UNAVAILABLE AND BLEEDING OCCURRED REQUIRING ADDITIONAL INTERVENTION. AN ICEFX CRYOABLATION SYSTEM AND THREE ICEPEARL 2.1 CX 90 DEGREE NEEDLES WERE SELECTED FOR THE TREATMENT OF RENAL CELL CARCINOMA. THE FIRST FREEZE CYCLE WAS PERFORMED IN THE KIDNEY, FOLLOWED BY PASSIVE AND FAST THAW CYCLES. THE GAS TANK WAS CHANGED. THE SECOND FREEZE CYCLE WITH PASSIVE THAW WAS COMPLETED. THE GAS TANK WAS CHANGED AGAIN. AN ITHAW ERROR OCCURRED AND BOTH ITHAW AND CAUTERY OPTIONS WERE UNAVAILABLE (GREYED OUT ON SCREEN). TROUBLESHOOTING WAS PERFORMED BUT BOTH I-THAW AND CAUTERY WERE STILL UNAVAILABLE AND TO USE PASSIVE THAW. THE PHYSICIAN EASILY REMOVED THE NEEDLES AFTER 6-8 MINUTES OF PASSIVE THAW. AS SOON AS THE NEEDLES WERE REMOVED, THE PATIENT STARTED BLEEDING. PRESSURE AND A NON-BSC EMBOLIZATION GELATIN WERE USED IN THE NEEDLES TRACKS, DOWN TO THE KIDNEY. AN ARTERIAL COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED TO CHECK THAT THE BLEEDING HAD STOPPED. THE PROCEDURE WAS CUT SHORT AS ANOTHER FREEZE CYCLE ON ANOTHER AREA OF THE LESION HAD BEEN PLANNED. THE PATIENT WAS THEN EXTUBATED AND SENT OVERNIGHT TO THE WARD FOR OBSERVATION. TWO DAYS POST-P

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15232090 ↗
• InjuryAug 16, 2022Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT THE ITHAW AND CAUTERY OPTIONS WERE UNAVAILABLE AND BLEEDING OCCURRED REQUIRING ADDITIONAL INTERVENTION. AN ICEFX CRYOABLATION SYSTEM AND THREE ICEPEARL 2.1 CX 90 DEGREE NEEDLES WERE SELECTED FOR THE TREATMENT OF RENAL CELL CARCINOMA. THE FIRST FREEZE CYCLE WAS PERFORMED IN THE KIDNEY, FOLLOWED BY PASSIVE AND FAST THAW CYCLES. THE GAS TANK WAS CHANGED. THE SECOND FREEZE CYCLE WITH PASSIVE THAW WAS COMPLETED. THE GAS TANK WAS CHANGED AGAIN. AN ITHAW ERROR OCCURRED AND BOTH ITHAW AND CAUTERY OPTIONS WERE UNAVAILABLE (GREYED OUT ON SCREEN). TROUBLESHOOTING WAS PERFORMED BUT BOTH I-THAW AND CAUTERY WERE STILL UNAVAILABLE AND TO USE PASSIVE THAW. THE PHYSICIAN EASILY REMOVED THE NEEDLES AFTER 6-8 MINUTES OF PASSIVE THAW. AS SOON AS THE NEEDLES WERE REMOVED, THE PATIENT STARTED BLEEDING. PRESSURE AND A NON-BSC EMBOLIZATION GELATIN WERE USED IN THE NEEDLES TRACKS, DOWN TO THE KIDNEY. AN ARTERIAL COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED TO CHECK THAT THE BLEEDING HAD STOPPED. THE PROCEDURE WAS CUT SHORT AS ANOTHER FREEZE CYCLE ON ANOTHER AREA OF THE LESION HAD BEEN PLANNED. THE PATIENT WAS THEN EXTUBATED AND SENT OVERNIGHT TO THE WARD FOR OBSERVATION. TWO DAYS POST-P

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15232082 ↗
• InjuryAug 16, 2022Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT THE ITHAW AND CAUTERY OPTIONS WERE UNAVAILABLE AND BLEEDING OCCURRED REQUIRING ADDITIONAL INTERVENTION. AN ICEFX CRYOABLATION SYSTEM AND THREE ICEPEARL 2.1 CX 90 DEGREE NEEDLES WERE SELECTED FOR THE TREATMENT OF RENAL CELL CARCINOMA. THE FIRST FREEZE CYCLE WAS PERFORMED IN THE KIDNEY, FOLLOWED BY PASSIVE AND FAST THAW CYCLES. THE GAS TANK WAS CHANGED. THE SECOND FREEZE CYCLE WITH PASSIVE THAW WAS COMPLETED. THE GAS TANK WAS CHANGED AGAIN. AN ITHAW ERROR OCCURRED AND BOTH ITHAW AND CAUTERY OPTIONS WERE UNAVAILABLE (GREYED OUT ON SCREEN). TROUBLESHOOTING WAS PERFORMED BUT BOTH I-THAW AND CAUTERY WERE STILL UNAVAILABLE AND TO USE PASSIVE THAW. THE PHYSICIAN EASILY REMOVED THE NEEDLES AFTER 6-8 MINUTES OF PASSIVE THAW. AS SOON AS THE NEEDLES WERE REMOVED, THE PATIENT STARTED BLEEDING. PRESSURE AND A NON-BSC EMBOLIZATION GELATIN WERE USED IN THE NEEDLES TRACKS, DOWN TO THE KIDNEY. AN ARTERIAL COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED TO CHECK THAT THE BLEEDING HAD STOPPED. THE PROCEDURE WAS CUT SHORT AS ANOTHER FREEZE CYCLE ON ANOTHER AREA OF THE LESION HAD BEEN PLANNED. THE PATIENT WAS THEN EXTUBATED AND SENT OVERNIGHT TO THE WARD FOR OBSERVATION. TWO DAYS POST-P

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15232081 ↗
• MalfunctionJun 24, 2022Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT FROST OCCURRED ON THE NEEDLE SHAFT. AN ICEPEARL 2.1 CX 90 DEGREE NEEDLE WAS SELECTED FOR A RENAL CRYOABLATION PROCEDURE. DURING THE PROCEDURE AT 2 MINUTES, IT WAS NOTICED THAT THE EXPOSED PORTION OF ONE NEEDLE WAS FROSTING. THE REMAINING TWO NEEDLES WERE SATISFACTORY. THE AFFECTED NEEDLE STOPPED AND ABLATION WAS COMPLETED WITH THE REMAINING TWO ICEPEARL NEEDLES. ALL THREE PROBES PASSED THE LEAKAGE TEST PRIOR TO INSERTION IN THE PATIENT. AN OBSERVATION OF THE SKIN ENTRY POINT REVEALED NO INJURY. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENTS STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14806705 ↗
• MalfunctionMar 29, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT TWO NEEDLES OF THE SAME LOT HAD LEAKS DISCOVERED DURING THE PREP PHASE. TWO ICEPEARL 2.1 CX 90 DEGREE NEEDLES FROM THE SAME BATCH WERE SELECTED FOR TREATMENT OF RENAL CELL CARCINOMA. DURING THE PREP/TESTING PHASE, WHILE OUTSIDE THE PATIENT, THE NEEDLES WERE FULLY SUBMERGED IN SALINE FOR INTEGRITY TESTING AND A GAS LEAK WAS FOUND NEAR THE NEEDLE TIP OF BOTH NEEDLES. IT WAS FURTHER NOTED THAT ONE OF THE NEEDLES ALSO HAD A LEAK AT THE SHAFT TO NEEDLE JOINT. TWO NEW NEEDLES WERE TESTED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13938292 ↗
• MalfunctionMar 29, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT TWO NEEDLES OF THE SAME LOT HAD LEAKS DISCOVERED DURING THE PREP PHASE. TWO ICEPEARL 2.1 CX 90 DEGREE NEEDLES FROM THE SAME BATCH WERE SELECTED FOR TREATMENT OF RENAL CELL CARCINOMA. DURING THE PREP/TESTING PHASE, WHILE OUTSIDE THE PATIENT, THE NEEDLES WERE FULLY SUBMERGED IN SALINE FOR INTEGRITY TESTING AND A GAS LEAK WAS FOUND NEAR THE NEEDLE TIP OF BOTH NEEDLES. IT WAS FURTHER NOTED THAT ONE OF THE NEEDLES ALSO HAD A LEAK AT THE SHAFT TO NEEDLE JOINT. TWO NEW NEEDLES WERE TESTED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13938289 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A MAJOR BLEED OCCURRED. DURING A RIGHT RENAL CRYOABLATION PROCEDURE, TWO ICEPEARL 2.1 CX 90 DEGREE NEEDLES WERE USED. UPON REMOVING THE NEEDLES FROM THE PATIENT, A BLEED WAS VERIFIED IN BOTH PERINEPHRIC AND RENAL COLLECTING SYSTEM WITH SIGNIFICANT HEMATURIA. THE PHYSICIAN PERFORMED AN ANGIOGRAM WHILE THE PATIENT WAS STILL UNDER GENERAL ANESTHESIA AND FOUND A PSEUDOANEURYSM WITH NO OBVIOUS ACTIVE BLEEDING WHICH WAS TREATED BY COIL EMBOLIZATION. THE PATIENT WAS THEN MANAGED CONSERVATIVELY AND STAYED IN THE HOSPITAL FOR A FEW DAYS REQUIRING BLADDER IRRIGATION. THE PHYSICIAN STATED THE CAUSE OF THE BLEED WAS DUE TO AN ICE BALL FRACTURE OF A FAIRLY CENTRAL LESION. A FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN IN 2-3 MONTHS IS EXPECTED.

  Patient problems: Hematuria; Hemorrhage/Blood Loss/Bleeding; Pseudoaneurysm

  MAUDE report 13261319 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A MAJOR BLEED OCCURRED. DURING A RIGHT RENAL CRYOABLATION PROCEDURE, TWO ICEPEARL 2.1 CX 90 DEGREE NEEDLES WERE USED. UPON REMOVING THE NEEDLES FROM THE PATIENT, A BLEED WAS VERIFIED IN BOTH PERINEPHRIC AND RENAL COLLECTING SYSTEM WITH SIGNIFICANT HEMATURIA. THE PHYSICIAN PERFORMED AN ANGIOGRAM WHILE THE PATIENT WAS STILL UNDER GENERAL ANESTHESIA AND FOUND A PSEUDOANEURYSM WITH NO OBVIOUS ACTIVE BLEEDING WHICH WAS TREATED BY COIL EMBOLIZATION. THE PATIENT WAS THEN MANAGED CONSERVATIVELY AND STAYED IN THE HOSPITAL FOR A FEW DAYS REQUIRING BLADDER IRRIGATION. THE PHYSICIAN STATED THE CAUSE OF THE BLEED WAS DUE TO AN ICE BALL FRACTURE OF A FAIRLY CENTRAL LESION. A FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN IN 2-3 MONTHS IS EXPECTED.

  Patient problems: Hematuria; Hemorrhage/Blood Loss/Bleeding; Pseudoaneurysm

  MAUDE report 13260523 ↗
• MalfunctionDec 15, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THE NEEDLE SHAFT FROZE. A ICEPEARL 2.1 CX 90 DEGREE NEEDLE WAS BEING USED IN A CRYOABLATION CASE. THE NEEDLE PASSED THE TESTING PHASE BUT WHEN INSERTED INTO THE PATIENT AND THE STICK FUNCTION WAS ACTIVATED, THE NEEDLE BEGAN TO FREEZE DOWN THE SHAFT BUT DID NOT REACH THE PATIENTS SKIN BEFORE IT WAS NOTICED. THE NEEDLE WAS WARMED AND REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT NEEDLE WITH NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13011506 ↗
• MalfunctionDec 15, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT A NEEDLE FROST OCCURRED. AN ICEPEARL 2.1 CX 90 DEGREE NEEDLE WAS SELECTED FOR TREATMENT OF A RENAL CELL CARCINOMA IN THE PATIENT. THE NEEDLE PASSED TESTING AND WAS INSERTED INTO THE PATIENT. WHEN THE STICK OPTION WAS INITIATED THE SHAFT BEGAN TO FREEZE AND ICE WENT DOWN THE NEEDLE SHAFT. THE NEEDLE WAS WARMED AND REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13011322 ↗
• MalfunctionDec 3, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THERE WAS FROST ON NEEDLE SHAFT. AN ICEPEARL 2.1 CX 90 DEGREE NEEDLE WAS SELECTED FOR USE IN A CRYOABLATION PROCEDURE TREATING BACK PAIN. TWO MINUTES INTO THE FIRST FREEZE CYCLE, FROST WAS NOTICED ON THE NEEDLE SHAFT. FREEZING WAS STOPPED, SALINE WAS PUT ON THE SKIN, AND THE NEEDLE WAS THAWED AND REMOVED FROM THE PATIENT. NO SIGN OF FROST BITE WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH A NEW NEEDLE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12927052 ↗
• MalfunctionOct 29, 2021Thermal Decomposition of Device; Insufficient Heating; Thermal Decomposition of Device; Insufficient Heating

  IT WAS REPORTED THERE WAS NEEDLE SHAFT FROST. AN ICEPEARL 2.1 CX 90 DEGREE NEEDLE WAS SELECTED FOR A CRYOABLATION PROCEDURE IN THE LUNG. THERE WAS APPROXIMATELY 5CM OF THE NEEDLE SHAFT OUTSIDE THE SKIN. WITHIN 20-30 SECONDS OF THE INITIAL FREEZE, THE NEEDLE SHAFT FROSTED OVER AND THERE WAS FROST ON THE SKIN. WARM SALINE WAS USED AROUND THE SKIN. THREE FREEZE CYCLES WERE COMPLETED. AT THE END OF THE PROCEDURE THE NEEDLE WAS ABLE TO FAST THAW BUT WAS NOT ABLE TO COME TO TEMPERATURE OR COMPLETE THE CAUTERY FUNCTION. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12721328 ↗
• MalfunctionOct 4, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A NEEDLE SHAFT LEAK OCCURRED. AN ICEPEARL NEEDLE WAS SELECTED FOR USE DURING A CRYOABLATION PROCEDURE. DURING THE NEEDLE TEST PHASE, BUBBLES WERE NOTED COMING FROM THE SHAFT. THE NEEDLE WAS DISCARDED AND THE PROCEDURE CONTINUED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12572690 ↗
• MalfunctionAug 26, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT FROST ON THE NEEDLE SHAFT OCCURRED. AN ICEPEARL 2.1 CX 90 DEGREE NEEDLE WAS IN USE DURING A BREAST CRYOABLATION PROCEDURE WHEN DURING THE SECOND FREEZE CYCLE FROST WAS VISIBLE ON THE NEEDLE SHAFT, AS WELL AS, THE HUB AND CABLES. THE PATIENTS SKIN WAS ALREADY BEING MANAGED WITH WARM WATER IN A STERILE GLOVE AND CHECKED BY THE PHYSICIAN. NO ADVERSE EVENT OCCURRED AS A RESULT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12372233 ↗
• MalfunctionAug 18, 2021Gas/Air Leak; Adverse Event Without Identified Device or Use Problem; Gas/Air Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NEEDLE SHAFT LEAK OCCURRED. AN ICEPEARL 2.1 CX 90 DEGREE NEEDLE WAS SELECTED FOR USE AND DURING DEVICE PREPARATION A SHAFT LEAK WAS NOTED. A NEW NEEDLE WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12337401 ↗
• MalfunctionApr 2, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT FROST ON THE NEEDLE SHAFT OCCURRED. THREE ICEPEARL 2.1 CX 90 DEGREE NEEDLES WERE TESTED SUCCESSFULLY AND USED TO PERFORM A PERCUTANEOUS RENAL ABLATION PROCEDURE. DURING THE FIRST FREEZE CYCLE, ONE OF THE NEEDLES HAD ICE FORMING ON THE ENTIRE NEEDLE SHAFT TO THE SKIN. THE PHYSICIAN WRAPPED THE NEEDLES WITH STERILE GAUZE AT THE SKIN AND CONTINUOUSLY IRRIGATED THE NEEDLE WITH SALINE DURING BOTH FREEZE CYCLES. THE TREATMENT WAS COMPLETED WITH NO EVIDENCE OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11607728 ↗