Visualase 9735560 (UDI 00763000416430)Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00763000416430), received between Feb 18, 2022 and Sep 28, 2026 — classified as 5 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (38 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 14, 2022Open, Classified

   Due to a defect in the outer pouch sterile seal

   Z-0244-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916378 ↗
• MalfunctionApr 23, 2026Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT A NEWLY OPENED COOLING CATHETER IN A 10 MM KIT WAS KINKED. THE CUSTOMER WAS ABLE TO OPEN A NEW ONE AND MOVE FORWARD WITH THEIR CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24974792 ↗
• MalfunctionApr 15, 2026Leak/Splash

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED AFTER A CASE THEY NOTICED AN UNUSUAL AMOUNT OF LIQUID, POSSIBLY SALINE FROM THE COOLING CATHETER, PRESENT AROUND THE PATIENT'S HEAD. THERE WERE NO ISSUES DURING THE PROCEDURE; NO INDICATION OF A POSSIBLE LEAK PRIOR TO THE PROCEDURE. THERE WAS NO DELAY. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886967 ↗
• MalfunctionMar 23, 2026Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE CYLINDER THAT CONNECTS TO THE RETURN BAG WAS MOUNTED UPSIDE DOWN, SO THE HOLDER DID NOT WORK WITHOUT KINKING THE TUBE TO THE BAG CONNECTOR. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665040 ↗
• MalfunctionJan 23, 2026Thermal Decomposition of Device; Leak/Splash

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A NEURO ABLATION PROCEDURE.. IT WAS REPORTED THAT ONE OF THE CATHETERS HAD A CHARRED TIP. THIS WAS SEEN UPON REMOVING THE CATHETER. THE LOCAL REPRESENTATIVE (REP) TESTED WITH SALINE INSIDE OF THE CATHETER TO SEE IF THERE WAS A LEAK, AND THERE WAS FOUND TO BE A VERY SMALL LEAK AT THE TIP OF THE CATHETER. NO HARM TO THE PATIENT WAS FOUND AND THE SURGEON WAS AWARE. THERE WAS NO DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24164295 ↗
• MalfunctionDec 30, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE CATHETER WAS TIGHT WHEN TRYING TO INSERT THE STIFFENING STYLET. NEW CATHETER NEEDED TO BE OPENED. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922214 ↗
• MalfunctionNov 17, 2025Insufficient Heating; Insufficient Heating

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE 10MM TIP HAD ABNORMAL HEATING. THE TIP WAS ONLY HEATING IN THE PROXIMAL 1/3 RATHER THAN THE FULL LENGTH. IT WAS NOTED THAT IT APPEARED TO BE AN ISSUE WITH THE DISPOSABLE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570229 ↗
• MalfunctionOct 16, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT WHEN THE SITE OPENED A CATHETER KIT TO PREP FOR SURGERY, IT WAS DISCOVERED THAT THE STIFFENING STYLET WOULD NOT FIT INTO THE COOLING CATHETER AS EXPECTED. SITE OPENED A NEW KIT FOR A NEW CATHETER, AND HAD NO ISSUES PLACING THE STIFFENING STYLET INTO THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23314512 ↗
• MalfunctionSep 5, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT WHEN INSERTING A 10MM LASER FIBER, IT WAS NOTICED THAT THE SHEATH WAS NOT CONNECTED TO THE HUB PORTION OF THE CATHETER AND BECAME SEPARATED. THEY WERE ABLE TO OPEN UP ANOTHER CATHETER AND PLACE IT SUCCESSFULLY. HOWEVER, IT WAS NOTED THAT THE NON-FUNCTIONING CATHETER WAS DISCARDED AND THEY WERE UNABLE TO RETRIEVE IT IN THE SHARPS. THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983623 ↗
• MalfunctionAug 19, 2025Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THERE WAS A LEAK IN THE EXTERNAL PORTION OF THE CATHETER. THERE WAS NO DELAY AND NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841418 ↗
• MalfunctionJul 15, 2025Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THERE WAS A SALINE LINE LEAK. THE SALINE RETURN LINE HAD A FAILURE. THIS CAUSED A LEAK AT THE RETURN LINE CONNECTION POINT. NO WATER WAS IN THE SCANNER OR ON THE PATIENT. THERE WAS NO REPORTED DELAY TO THE CASE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22504728 ↗
• MalfunctionJul 8, 2025Thermal Decomposition of Device; Temperature Problem; Thermal Decomposition of Device; Temperature Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT AFTER A PROCEDURE IN WHICH THREE LASER CATHETERS WERE SEQUENTIALLY CONNECTED, A MANUFACTURER REPRESENTATIVE (REP) NOTICED THE THIRD CATHETER'S TIP WAS CHARRED. THERE WERE NO ISSUES WITH THE PROCEDURE OUTCOME. THE FIRST TWO LASER ABLATIONS HAD NO ISSUES, BUT ON THE THIRD THE REP NOTICED SOME ABNORMAL HEATING AT THE TIP. SEVERAL MINUTES IN, THERE MAY HAVE BEEN A "BUBBLE EVENT" OR "STEAM EVENT". THE SYSTEM SHUT OFF, BUT AFTER IT REBOOTED THE PROCEDURE PROCEEDED NORMALLY. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437672 ↗
• MalfunctionJun 13, 2025Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT DURING A MULTIPLE CATHETER CASE THE SYSTEM WORKED AS EXPECTED FOR THE FIRST THREE CATHETERS. AFTER SWITCHING THE SALINE TUBING CONNECTION FOR THE NEXT CATHETERS, SALINE STOPPED GETTING PULLED OUT OF THE BAG TO CIRCULATE THROUGH THE TUBING SYSTEM. IT MAY HAVE STARTED INITIALLY BUT THEN STOPPED. TURNED OFF THE PUMP AND TRIED SEVERAL TROUBLESHOOTING ATTEMPTS ON THE PUMP SIDE, INCLUDING RESEATING THE TUBING, CHANGING THE SHORT SECTION OF THE TUBING, A NEW SALINE BAG AND A SECOND PUMP, AS THIS ACCOUNT HAS AN EXTRA ONE. SALINE WOULD NOT COME OUT OF THE BAG. MADE A SEPARATE SALINE CIRCUIT WITH DIFFERENT TUBING AND A DEMO CATHETER AND THAT WORKED, SO THAT ELIMINATED THE PUMP AS A PROBLEM. DECIDED TO CHANGE THE LONG SET OF TUBING AND CHECK IF THE CURRENT TUBING WAS PINCHED AN YWHERE. NO OBVIOUS KINKS OR PINCHES IN THE EXISTING TUBING SET WERE OBSERVED, BUT IT WAS REPLACED, AS THAT HAS NOT BEEN TRIED YET. IT TOOK SOME TIME TO DISCONNECT THE TUBING. WHILE CHANGING THE TUBING, THE FELLOW NOTICED THAT ONE OF THE BOLTS WAS A LITTLE WOBBLY. THIS BOLT D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206497 ↗
• MalfunctionMay 22, 2025Mechanical Problem; Biocompatibility; Mechanical Problem; Biocompatibility

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT WHEN STARTING THE SALINE PUMP FOR THE FIRST LASER (RIGHT SIDE) THEY NOTICED NOISY ARTIFACT ON THE TEMPERATURE MAP (TMAP) IMAGING. THEY NOTICED SALINE HAD NOT MADE IT BACK TO THE RETURN BAG. THEY CHECKED FOR LEAKS NEAR THE BOLT CAP OR ANYWHERE NEAR THE CATHETERS, THERE WERE NO LEAKS VISIBLE. THE MEDTRONIC REP EXPRESSED CONCERN TO SURGEON. THEY RAN T1 T2 3D IMAGING SCANS. IT SEEMED LIKE THE ARTIFACT WAS AIR. IT WAS NOTED THAT THE 2 LASERS USED WERE DAISY CHAINED TOGETHER. THE SURGEON DECIDED TO PROCEED WITH THE SECOND LASER (LEFT SIDE) AND CHANGED THE TUBING CONNECTION TO JUST FLOW TO THE SECOND CATHETER (LEFT). THEY PROCEEDED WITH NO COMPLICATIONS. AT THE END OF THE CASE, UPON REMOVAL OF THE RIGHT CATHETER, IT WAS NOTED THAT THE TIP OF THE CATHETER WAS BENT. THE REP PRESSURE TESTED IT WITH SALINE, SALINE LEAKED AT THE TIP AND NOTHING WOULD ENTER THE RETURN LINE OF CATHETER. IT WAS NOTED THAT THERE WAS A BEND NEAR THE 95MM MARK ON THE CATHETER. THAT HAPPENED AFTER TRANSPORTING PATIENT OUT OF MRI. IT HAD NOTHING TO DO WITH WHY THE TIP WAS B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069759 ↗
• InjuryApr 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT A BLEED IN THE BRAIN OCCURRED AFTER THE VISUALASE COOLING LASER APPLICATOR SYSTEM (VCLAS) CATHETER WAS PLACED. THE BLEED WAS DETECTED IN THE MAGNETIC RESONANCE IMAGING (MRI) SCANNER PRIOR TO LASER ABLATION. THE SURGEON MADE THE DECISION TO ABORT THE LASER ABLATION AND DO AN OPEN CRANIOTOMY TO FIX THE BLEED AND REMOVE THE INTENDED LESION. IN DISCUSSIONS WITH THE NEUROSURGEON AND NEUROLOGIST, IT WAS DETERMINED THAT THE BURR HOLE FOR THE CATHETER PLACEMENT DIFFERED FROM THE PLANNED TRAJECTORY. THIS CONTRIBUTED TO THE BIOPSY OCCURRING IN THE INCORRECT LOCATION, LIKELY RESULTING IN A BLEED. BLOOD WAS SEEN COMING OUT OF THE TOP OF THE BONE ANCHOR, PRIOR TO THE CATHETER BEING PLACED, INDICATING THAT THE BLEED OCCURRED DURING THE BIOPSY. IT WAS NOTED THAT A POSSIBLE REASON FOR THE INACCURACY OF THE BURR HOLE PLACEMENT WAS THAT THE COSMAN-ROBERTS-WELLS (CRW) STEREOTACTIC HEAD FRAME HAD SLIPPED FROM THE PLANNED COORDINATES. ANOTHER POSSIBLE REASON WAS THAT THE HEAD PINS OF THE FRAME HAD SLIPPED FROM THE POSITION THEY WERE IN DURING THE INITIAL COMPUTED TOMO

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21927978 ↗
• MalfunctionMar 31, 2025Thermal Decomposition of Device; Mechanical Problem; Thermal Decomposition of Device; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THERE WAS A TUMOR IN THE AMYGDALA WITH A LARGE CALCIUM DEPOSIT IN THE MIDDLE WHICH OBSCURED THE IMAGING, HEAT SPREAD, AND TEMPERATURE MAP (TMAP). AFTER TWO INITIAL HEAT ATTEMPTS AND UNEVEN, INACCURATE HEAT READINGS CORRESPONDING TO THE AMOUNT OF POWER, A PULLBACK WAS MADE TO DETERMINE IF IT WAS THE CALCIUM DEPOSIT THAT WAS THE ISSUE, OR IF IT WAS THE FIBER. THEY REHEATED IN A NEW SPOT AND HAD THE SAME LOW HEAT PROFILE. THE LASER FIBER WAS BROKEN CLEAN AT THE TIP WITH SLIGHT CHARRING DISCOLORATION, BUT IT WAS NOT MELTING THE FIBER NOR THE CATHETER. ALSO, THE CATHETER HAD BEEN TIGHTENED TOO TIGHTLY AT THE BONE ANCHOR AND WAS BROKEN AT THE ANCHOR SITE. IT HELD TOGETHER AND WAS NOT DETECTABLE UNTIL THEY HAD TO REMOVE THE BROKEN LASER FIBER, WHICH WAS NOT EASILY REMOVED DUE TO THE TIGHTENING AT THE BONE ANCHOR. THE BONE ANCHOR BLUE CAP WAS LOOSENED, THE FIBERS WERE EXCHANGED AND THAT WAS WHEN THE SURGEON SAW BENDING ON THE CATHETER. WATER WAS RAN TO DETERMINE THE DAMAGE AND WATER RETURN. IT WAS NOTED THAT SALINE WAS RETURNING TO THE DRAINAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731698 ↗
• MalfunctionMar 19, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SURGEON WAS HAVING DIFFICULTY ADVANCING THE CATHETER THROUGH THE BOLT. THE CATHETER WAS WITHDRAWN, AND IT WAS CONFIRMED THAT THE DURA WAS OPEN USING A SPINAL NEEDLE. THEY TRIED AGAIN AND WERE STILL MET RESISTANCE. THE SURGEON WAS ABLE TO PASS THE ALIGNMENT ROD THROUGH THE BOLT AND THE SKULL EASILY. THE PLASTIC BONE ANCHOR WAS OPENED TO SEE IF THE CATHETER WOULD PASS SMOOTHLY THROUGH IT AND THAT ALSO WAS MET WITH RESISTANCE. THE SURGEON TOUCHED THE CATHETER AND NOTICED AN AREA THAT WAS NOT SMOOTH TOWARD THE DISTAL END. ANOTHER PRODUCT WAS OPENED, AND THAT CATHETER WENT THROUGH THE BOLT AS USUAL. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643979 ↗
• MalfunctionMar 18, 2025Mechanical Problem; Biocompatibility; Mechanical Problem; Biocompatibility

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE WAS A LASER THERMAL ABLATION UNDER MAGNETIC RESONANCE IMAGING (MRI). THERE WAS A 10 MINUTE DELAY TO THE CASE. THE LIQUID DID NOT LEAK INTO THE PATIENT. THE LEAK OCCURRED CLOSE TO THE END OF THE CATHETER; WHERE THE BLUE SHRINKAGE TUBING STARTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21631644 ↗
• MalfunctionMar 13, 2025Thermal Decomposition of Device; Mechanical Problem; Infusion or Flow Problem; Thermal Decomposition of Device; Mechanical Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE PUMP WAS ONLY WORKING IN THE EXTREMES. IT WAS SET TO LOW AND DID NOT ALLOW WATER OUT, OR HIGH AND TOO MUCH FLUID. IT SEEMED THAT THE LOW FLOW OF FLUID RESULTED IN TWO MELTED CATHETERS. DURING THE ABLATION THE SURGEON NOTICED IT HEATING UP TOO QUICKLY, AND THERE WAS NO SALINE RETURN. UPON SETUP AND PRIOR TO THE LASER BEING TURNED ON, THERE WAS SALINE RETURN. THE SURGEON EXAMINED THE 10MM LASER FIBER AND FOUND THAT THE TIP HAD MELTED. THE SURGEON PERFORMED A TEST DOSE AT 30%, AND THEN WENT UP TO 65%. THE SURGEON THEN PLACED A SECOND 10MM CATHETER AND COMPLETED THE ABLATION. AT THE END OF THE CASE, THE SURGEON NOTICED A SMALL AMOUNT OF BLOOD IN THE SALINE TUBING ON THE CATHETER AND FOUND THAT THE TIP OF THAT CATHETER HAD A SMALL AMOUNT OF CHARRING. THE TIP HAD ALSO MELTED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596383 ↗
• MalfunctionMar 13, 2025Thermal Decomposition of Device; Infusion or Flow Problem; Thermal Decomposition of Device; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE PUMP WAS ONLY WORKING IN THE EXTREMES. IT WAS SET TO LOW AND DID NOT ALLOW WATER OUT, OR HIGH AND TOO MUCH FLUID. IT SEEMED THAT THE LOW FLOW OF FLUID RESULTED IN TWO MELTED CATHETERS. DURING THE ABLATION THE SURGEON NOTICED IT HEATING UP TOO QUICKLY, AND THERE WAS NO SALINE RETURN. UPON SETUP AND PRIOR TO THE LASER BEING TURNED ON, THERE WAS SALINE RETURN. THE SURGEON EXAMINED THE 10MM LASER FIBER AND FOUND THAT THE TIP HAD MELTED. THE SURGEON PERFORMED A TEST DOSE AT 30%, AND THEN WENT UP TO 65%. THE SURGEON THEN PLACED A SECOND 10MM CATHETER AND COMPLETED THE ABLATION. AT THE END OF THE CASE, THE SURGEON NOTICED A SMALL AMOUNT OF BLOOD IN THE SALINE TUBING ON THE CATHETER AND FOUND THAT THE TIP OF THAT CATHETER HAD A SMALL AMOUNT OF CHARRING. THE TIP HAD ALSO MELTED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596378 ↗
• MalfunctionMar 6, 2025Thermal Decomposition of Device; Mechanical Problem; Thermal Decomposition of Device; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE CATHETER TIP MELTED, RESULTING IN A SALINE LEAK INTO THE ABLATION ZONE IN THE BRAIN'S FRONTAL LOBE. RETURN FLOW APPEARED CONSISTENT WITH SUPPLY FLOW, SO IT WAS DIFFICULT TO DETECT. THE ISSUE WAS DISCOVERED DURING THE MAGNETIC RESONANCE IMAGING (MRI) WORKFLOW. THE ABLATION WAS STOPPED TO PERFORM DIFFUSION, FLARE, AND T1 SCANS TO CONFIRM THAT NO BLEED IN THE BRAIN OCCURRED. DESPITE THE ISSUE, THE SURGEON CHOSE TO CONTINUE WITH THE ABLATION, ALTHOUGH THE HEAT WAS MUCH MORE DIFFUSED IN SUBSEQUENT ABLATIONS. IT WAS NOTED THAT THERE WERE FOUR ABLATIONS PERFORMED THAT DID NOT OVERLAP. EACH PULLBACK WAS MEASURED TO BE 5-6MM. THE EVENT WAS NOTIFIED AT THE END OF THE FIRST ABLATION. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21537638 ↗
• MalfunctionFeb 21, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT WHEN OPENING A COOLING CATHER, IT WAS DISCOVERED THAT IT HAD A KINK IN IT. THERE WAS NO DELAY OR IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432838 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A GENERALIZED CONVULSIVE SEIZURE. IT HAPPENED WHEN THE PATIENTS WAS ALREADY AT HOME 8 DAYS AFTER THE PROCEDURE. THE PATIENT PRESENTED CONVULSIVE SEIZURES AND HAD BEEN HOSPITALIZED FOR 1 WEEK. THEY RECEIVED CORTICOTHERAPY IV 100MG FROM (B)(6). THE FOLLOWING EXAMS HAD BEEN PERFORMED: TDM ON (B)(6), EEG ON (B)(6), IRM ON (B)(6), RX ON (B)(6), TDM THORAX ON (B)(6), TDM ON (B)(6). THEY WERE RELEASED FROM THE HOSPITAL WITHOUT CONSEQUENCES.

  Patient problems: Convulsion/Seizure

  MAUDE report 21410398 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A GENERALIZED CONVULSIVE SEIZURE. IT HAPPENED WHEN THE PATIENTS WAS ALREADY AT HOME 8 DAYS AFTER THE PROCEDURE. THE PATIENT PRESENTED CONVULSIVE SEIZURES AND HAD BEEN HOSPITALIZED FOR 1 WEEK. THEY RECEIVED CORTICOTHERAPY IV 100MG FROM (B)(6) 2024. THE FOLLOWING EXAMS HAD BEEN PERFORMED: TDM ON (B)(6) 2024, EEG ON (B)(6) 2024, IRM ON (B)(6) 2024, RX ON (B)(6) 2024, TDM THORAX ON (B)(6) 2024, TDM ON (B)(6) 2024. THEY WERE RELEASED FROM THE HOSPITAL WITHOUT CONSEQUENCES.

  Patient problems: Convulsion/Seizure

  MAUDE report 21410371 ↗
• MalfunctionFeb 11, 2025Thermal Decomposition of Device; No Display/Image; Environmental Compatibility Problem; Thermal Decomposition of Device; No Display/Image; Environmental Compatibility Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT AFTER THE CASE, THERE WERE TRACES OF BLOOD FOUND IN THE COOLING LIQUID INSIDE THE CATHETER AND WHERE THEY CONNECT TO THE CATHETER. THE ABLATION WAS DONE ON A BIG CAVERNOMA, RENDERING THE INSIDE OF THE CAVERNOMA VERY NOISY AND HARD TO INTERPRET THE TEMPERATURE MAPPING. ALTHOUGH ADVISED TO STAY BELOW 75% OF LASER POWER, THE SURGEON DECIDED TO GO HIGHER TO REACH MORE OF THE BORDER OF THE CAVERNOMA. DUE TO THE TRACES OF BLOOD, IT WAS SUSPECTED THAT THE CATHETER WAS BURNED, ALLOWING BLOOD TO ENTER. SINCE THE CASE WAS FINISHED, NO FURTHER ACTION WAS TAKEN. DURING THE CASE, NO OBVIOUS INDICATION OF A LEAKING CATHETER WAS DETECTED. THE POST-OPERATIVE 3D IMAGES DID NOT SHOW ANY OBVIOUS EDEMA. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360517 ↗