RELIEVA SPINPLUS NAV RSP0616MFSNRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10705031241015), received between Aug 30, 2018 and Sep 25, 2026 — classified as 1 death, 5 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Incorrect Interpretation of Signal” (17 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Incorrect Interpretation of Signal

  It was reported that initially the SPINPLUS NAV 6x16mm 3 Guide (b)(6) "was tracking accurately until midway through the case it stopped being accurate." Inaccuracy was reportedly determined by "trying to get into frontal and showed the balloon in the brain. Inaccuracy was observed posterior. It was "off by 5 mm or more and then stopped tracking altogether". Staff opened a new SPINPLUS which was accurate from then on. There was no patient injury or delay in surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893073 ↗
• DeathFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Cardiac Arrest

  MAUDE report 24324825 ↗
• InjuryFeb 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A TRUDI¿ NAVIGATION CASE IN THE OPERATING ROOM (OR), A CEREBROSPINAL FLUID OR CSF LEAK WAS NOTICED IN THE PATIENT. THE CALLER REPORTED THAT THERE WERE NO ISSUES OR ERRORS OBSERVED ON THE TRUDI¿ NAVIGATION SYSTEM. THE CALLER REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN HAD NOTICED A SMALL CEREBROSPINAL FLUID LEAK IN THE PATIENT. THE CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED TO THE PATIENT WAS A MUCOSAL PATCH OR GRAFT. THE CALLER REPORTED THAT THE PATIENT WAS THEN SENT TO THE HOSPITAL FOR FURTHER MONITORING. THE CALLER WAS UNABLE TO CONFIRM IF THE PATIENT IS IN STABLE CONDITION AT THIS TIME. IT WAS ALSO REPORTED THAT THE FOLLOWING ACCLARENT PRODUCTS WERE USED DURING THIS CASE: RELIEVA SPINPLUS® NAV BALLOON - RSP0616MFSN, TRUDI¿ PROBE (70 DEGREE) - TDP0705, TRUDI¿ NAV SUCTION DEVICE (0 DEGREE) - TDNS000Z, TRUDI¿ NAV SUCTION DEVICE (70 DEGREE) - TDNS070Z, TRUDI¿ NAV SUCTION DEVICE (90 DEGREE) - TDNS090Z.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 21367347 ↗
• MalfunctionFeb 7, 2025Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT MIDWAY THROUGH A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) WITH BALLOON DILATION IN THE OPERATING ROOM, A TRUDI SYSTEM LOST ACCURACY. IT WAS STATED THAT THE TRUDI SUCTION DEVICE (TDNS000Z, LOT UNKNOWN), THE TRUDI SHAVER BLADE ¿ STRAIGHT, DOUBLE SERRATED, 4.0MM X 110MM (TSB4STR, UNKNOWN LOT) AND A RELEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM, 6X16MM (RSP0616MFSN, UNKNOWN LOT) WERE INACCURATELY DISPLAYED ON THE TRUDI SYSTEM. THE CALLER STATED THAT THE ISSUE OCCURRED THREE TIMES DURING THE CASE. THE PATIENT WAS REREGISTERED THE FIRST TWO TIMES THE ISSUE OCCURRED, AND THE ISSUE WOULD BE RESOLVED. THE THIRD TIME THAT THE ISSUE OCCURRED, THE PROCEDURE WAS CONTINUED WITHOUT RESOLUTION. THERE WAS NO ALLEGATION THAT A DEATH OR SERIOUS INJURY OCCURRED DUE TO THE USE OF THE PRODUCT. THERE WAS NO REPORT OF THE PATIENT REQUIRING MEDICAL INTERVENTION. NON ACCLARENT DEVICES WERE USED. ADDITIONAL EVENT INFORMATION RECEIVED ON 04-FEB-2025 INDICATED THAT THE CUSTOMER CONFIRMED ACCURACY USING THE REGISTRATION PROBE AFTER REGISTRATION PROCESS WAS COMPLETED. THE CUSTOMER CONFIRM ACCURACY MULTIPLE TIMES IN THE KNOWN LANDMARKS IN ENDOSCOPI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21334872 ↗
• MalfunctionMay 6, 2024Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY HYBRID BILATERAL FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) AND BALLOON SINUPLASTY (BSP) PROCEDURE ON (B)(6) 2024, UPON STARTING THE TRUDI SYSTEM, THE CONSOLE WAS DISPLAYED AS RED AND AN INSTRUMENT HUB CALIBRATION ERROR (UNKNOWN CODE) WAS DISPLAYED ON THE TRUDI SYSTEM. THE TRUDI SYSTEM WAS REBOOTED AND THE ISSUE WAS RESOLVED. THE PROCEDURE RESUMED. IT WAS ALSO REPORTED THAT THE ACCURACY WAS OFF BY APPROXIMATELY 4MM. THE 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / LOT# UNKNOWN), 4.0MM ¿ STRAIGHT (0°) TRUDI NAVIGATION SHAVER BLADE (TSB4STR / LOT# UNKNOWN), AND 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN / LOT# UNKNOWN) HAD ACCURACY ISSUES. NO TROUBLESHOOTING WAS PERFORMED. THE PROCEDURE WAS CONTINUED WITHOUT RESOLUTION. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED. THERE WAS NO MEDICAL INTERVENTION REQUIRED NOR REPORTED AS A RESULT OF THE REPORTED ISSUE WITH ACCURACY.ON 03-MAY-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE ADDITIONAL INFORMATION, ACCURACY WAS CONFIRMED BEFORE USING THE REGISTRATION PROBE AFTER THE REGISTRATION PROCESS WAS COMPLETED. ACCURACY WAS CONFIRMED VIA KNOWN LAND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19256245 ↗
• MalfunctionApr 25, 2024Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THE SPIN PLUS NAV BALLOON (RSP0616MFSN, LOT UNKNOWN) WAS BEING DISPLAYED INAPPROPRIATELY ON THE TRUDI SYSTEM VERSION 2.3.2.3 (400089). THE CALLER NOTED THAT THE ACCURACY AND LOCATION OF THE BALLOON WAS NOT DISPLAYED PROPERLY. TO TROUBLESHOOT, THE CABLE WAS RESEATED WITHOUT RESOLUTION. THE DONGLE WAS EXCHANGED WITHOUT RESOLUTION. THE BALLOON WAS EXCHANGED, AND THE ISSUE RESOLVED. THE CASE CONTINUED. THERE WAS NO ALLEGATION THAT A DEATH OR SERIOUS INJURY OCCURRED DUE TO THE USE OF THE PRODUCT. THERE WAS NO REPORT OF THE PATIENT REQUIRING MEDICAL INTERVENTION AS A RESULT OF THE ALLEGED PRODUCT ISSUE. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 03-APR-2024 INDICATING THAT THERE WAS NO MOVEMENT WITH THE PATIENT TRACKER OR THE PATIENT TRACKER CABLE UNDER TENSION IN RELATION TO THIS EVENT. NO MORE THAN ONE CT SCAN WAS ATTEMPTED TO BE USED WITH ONE DEVICE. THE CT IMAGE USED AS THE PRIMARY IMAGE. THERE WAS NO FERROMAGNETIC MATERIAL PLACED WITHIN THE TRUDI ZONE. THE EMITTER PAD NOR WAS PATIENT MOVED. WHEN THE ACCURACY ISSUE WAS OBSERVED, THE COLOR ON THE BAR WAS ¿GREEN¿ ON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19180136 ↗
• InjuryMar 22, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A BALLOON SINUPLASTY (BSP) PROCEDURE, THE PATIENT SUSTAINED AN INJURY TO HER CAROTID ARTERY THAT RESULTED IN HER SUFFERING A CATASTROPHIC STROKE. THE REPORTED DEVICES USED DURING THE PROCEDURE WERE: A RELIEVA TRACT BALLOON (RT1640A / 211202A-PC), TWO 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN), ONE FROM LOT 220419A-PC AND ONE FROM LOT 220504A-PC, A DISPOSABLE TRUDI PROBE 0-DEGREE, 5IN (TDP0005 / 210201B-PC), AN ACCLARENT BALLOON INFLATION DEVICE (BID30 / 96375250), AND A TRUDI NAV CABLE (TDNC001 / 211206C-PC) AND THE TRUDI NAVIGATION SYSTEM. IT IS REPORTED THAT THE PATIENT BELIEVED THAT THE ACCLARENT NAVIGATION BALLOON DILATION SYSTEM AND ITS COMPONENT PARTS, INCLUDING ANY AI (ARTIFICIAL INTELLIGENCE SOFTWARE) MAY HAVE MALFUNCTIONED AND FAILED TO PERFORM AS INTENDED DURING THE PROCEDURE, AND THAT AS A RESULT, THE PATIENT¿S CAROTID ARTERY WAS INJURED.

  Patient problems: Perforation of Vessels; Stroke/CVA

  MAUDE report 18963025 ↗
• InjuryMar 22, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A BALLOON SINUPLASTY (BSP) PROCEDURE, THE PATIENT SUSTAINED AN INJURY TO HER CAROTID ARTERY THAT RESULTED IN HER SUFFERING A CATASTROPHIC STROKE. THE REPORTED DEVICES USED DURING THE PROCEDURE WERE: A RELIEVA TRACT BALLOON (RT1640A / 211202A-PC), TWO 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN), ONE FROM LOT 220419A-PC AND ONE FROM LOT 220504A-PC, A DISPOSABLE TRUDI PROBE 0-DEGREE, 5IN (TDP0005 / 210201B-PC), AN ACCLARENT BALLOON INFLATION DEVICE (BID30 / 96375250), AND A TRUDI NAV CABLE (TDNC001 / 211206C-PC) AND THE TRUDI NAVIGATION SYSTEM. IT IS REPORTED THAT THE PATIENT BELIEVED THAT THE ACCLARENT NAVIGATION BALLOON DILATION SYSTEM AND ITS COMPONENT PARTS, INCLUDING ANY AI (ARTIFICIAL INTELLIGENCE SOFTWARE) MAY HAVE MALFUNCTIONED AND FAILED TO PERFORM AS INTENDED DURING THE PROCEDURE, AND THAT AS A RESULT, THE PATIENT¿S CAROTID ARTERY WAS INJURED.

  Patient problems: Perforation of Vessels; Stroke/CVA

  MAUDE report 18962997 ↗
• MalfunctionDec 14, 2023Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, RIGHT AFTER DILATING THE RIGHT SPHENOID SINUS, WHEN THE 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN / 231002A-PC) WAS REMOVED, IT BROKE IN HALF ACROSS THE DIAMETER AND SEPARATED FROM THE FLEXIBLE CATHETER. IT WAS REPORTED THAT TO TROUBLESHOOT, THE RELIEVA SPINPLUS NAV WAS REPLACED, THE ISSUE WAS RESOLVED AND THE PROCEDURE WAS RESUMED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 08-DEC-2023, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE SPINPLUS NAV WAS USED TO TREAT LEFT SPHENOID SINUS FIRST; THE RIGHT SPHENOID SINUS WAS DILATED SECOND. IT WAS NOT KNOWN IF THE SPINPLUS NAV BROKE AFTER IT WAS REMOVED FROM THE PATIENT¿S ANATOMY; PER THE ACCLARENT CLINICAL REPRESENTATIVE, ¿IT WAS BROUGHT TO MY ATTENTION OUTSIDE OF THE PATIENT¿S ANATOMY.¿ IT WAS UNKNOWN IF THE BALLOON CATHETER COMPONENT BROKE INTO TWO OR MORE PIECES. IT WAS NOT KNOWN IF THERE WERE ANY FRAGMENTS OF THE BALLOON CATHETER INSIDE THE PATIENT¿S RIGHT SPHENOID, ¿THE DR. DID A VISUAL EXAM UNDER DIRECT ENDOSCOPE VISUALIZATION. AND PROCEEDED WITH THE CASE.¿ I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18332266 ↗
• MalfunctionNov 3, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE PRIMARY BALLOON SINUPLASTY (BSP) PROCEDURE USING A 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN / 230911A-PC) A DAY AFTER THE COMPLETION OF A SOFTWARE UPDATE ON THE TRUDI NAVIGATION SYSTEM (FG200000 / SERIAL #: (B)(6)) , THE ACCURACY SEEMED TO BE OFF ACCORDING TO THE PHYSICIAN. IT WAS REPORTED THAT THE ACCURACY WAS OFF ¿BY MULTIPLE MILLIMETERS.¿ REBOOTING DID NOT RESOLVE THE ISSUE. THE COMPLAINT BALLOON WAS REPLACED AND THE ACCURACY ¿SEEMED TO BE IMPROVED BUT NOT COMPLETELY RESOLVED.¿ THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 24-OCT-2023, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, COMPUTED TOMOGRAPHY (CT) IMAGE WAS USED AS THE PRIMARY IMAGE. THE NUMBER OF SLICES CONTAINED ON THE CT SCAN IS NOT KNOWN. NOT MORE THAN ONE C SCAN WAS ATTEMPTED TO BE USED WITH THE DEVICE. THE PATIENT TRACKER DID NOT MOVE AND THE PATIENT TRACKER CABLE WAS NOT UNDER TENSION IN RELATION TO THE REPORTED ACCURACY BEING OFF ISSUE. THERE WAS NO FERROMAGNETIC MATERIAL PLACED WITHIN THE TRUDI ZONE. THE EMITTER PAD DID NOT MOVE. THE PATIENT DID NOT MOVE. WHEN THE ACCURACY ISSUE WAS OBSERVED, T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070079 ↗
• MalfunctionApr 5, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A REVISION HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE ON (B)(6) 2023, THERE WAS ACCURACY ISSUES WITH THE PATIENT TRACKER. WHEN THE PATIENT TRACKER WAS TAKEN OFF THE TEGADERM, IT LOOKED LIKE THERE WAS A TEAR ON THE RUBBER PIECE ON THE TRACKER. THE VISUAL LINE OF THE PATIENT AND THE VISUALS APPEARED OFF. IT WAS REPORTED THAT TO TROUBLESHOOT, THE 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (B)(4) WITHOUT RESOLUTION. THE PATIENT WAS RE-REGISTERED SEVERAL TIMES; THE PATIENT TRACKER WAS TAKEN OFF THE TEGADERM AND SAW THE SMALL TEAR IN THE TRACKER ITSELF. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. THE COMPLAINT DEVICE IS REPORTED AS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT WHEN THE ACCURACY ISSUE WAS OBSERVED, THE COLOR OF THE BAR BELOW THE BALLOON ICON ON THE TRUDI SYSTEM MONITOR WAS GREEN. THERE WAS NO ERROR MESSAGE ON THE TRUDI NAV MONITOR FOR THE DEVICE. THE DEVICE WAS PLUGGED IN THE FIRST TIME AFTER REGISTRATION. THE INFORMATION INDICATED THAT THE PATIENT TRACKER DID NOT MOVE; THE PATIENT T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686722 ↗
• MalfunctionMar 10, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, ¿UPON USING THE BALLOON CATHETER [A 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN / 221130B-PC)] IT WAS OBSERVED THAT IT WAS UNABLE TO NAVIGATE CORRECTLY.¿ THE BALLOON CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED AND THE PROCEDURE CONTINUED. THERE WAS REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 23-FEB-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION PROVIDED CLARIFICATION TO THE EVENT DESCRIPTION, ¿UNABLE TO NAVIGATE CORRECTLY¿ AS FOLLOWS, ¿NO ERROR MESSAGE, THE PHYSICIAN COULD TELL THE ACCURACY WAS OFF. NO OTHER INSTRUMENTS HAD BAD ACCURACY.¿ THERE WAS NO DIFFICULTY EXPERIENCED DURING THE ADVANCEMENT OF THE DEVICE INSIDE THE PATIENT¿S ANATOMY. THERE WAS NO DAMAGE OBSERVED TO THE DEVICE. WHEN THE ACCURACY ISSUE WAS OBSERVED, THE ICON ON THE TRUDI SYSTEM WAS GREEN. THE DEVICE WAS PLUGGED IN AFTER REGISTRATION. THE PATIENT TRACKER WAS NOT MOVED AND THE PATIENT TRACKER CABLE WAS NOT UNDER TENSION IN RELATION TO THE REPORTED ACCURACY ISSUE. COMPUTER TOMOGRAPHY (CT) IMAGE WAS THE PRIMARY IMAGE USED; THE CT SLICES WERE 0.5MM. IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16524735 ↗
• MalfunctionFeb 27, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE ON (B)(6) 2023, THE TRUDI NAVIGATION SYSTEM (S/N: (B)(4)) WAS SHOWING INACCURACIES AFTER SEVERAL ROUNDS OF REGISTRATION. A DISPOSABLE PATIENT TRACKER WAS INITIALLY USED, AND AFTER INACCURACIES WERE OBSERVED, A DECISION WAS MADE TO SWITCH TO THE REUSABLE PATIENT TRACKER. A SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN / LOT# UNKNOWN) AND A 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / 2111120) WERE USED. ONCE REGISTERED, THE INACCURACIES CONTINUED. REGISTRATION WAS DONE FOR A THIRD TIME WITH CONTINUED INACCURACY. THE PHYSICIAN WAS UNABLE TO DO ALL THEY WANTED TO DO WITH NAVIGATION DURING THE PROCEDURE; THEREFORE, THE NAVIGATION PORTION OF THE PROCEDURE WAS ABORTED. AFTER THE PROCEDURE, THE ACCLARENT REPRESENTATIVE REPORTEDLY SPENT 2.5 HOURS TROUBLESHOOTING WITH A MODEL HEAD. A NEW PATIENT PROBE, A REUSABLE PATIENT TRACKER, A NEW SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN) WERE USED DURING THE TROUBLESHOOTING; IT WAS REPORTED THAT THE 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / 2111120) USED DURING THE PROCEDURE WAS RE-STERILIZED AND WAS USED DURING THE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16449033 ↗
• MalfunctionNov 21, 2022Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE WITH BALLOON SINUPLASTY, THE FOLLOWING DEVICES WERE USED: A 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN / LOT# UNKNOWN), A 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / LOT#: UNKNOWN), AND AN UNKNOWN CURVE SUCTION DEVICE (CATALOG / LOT# UNKNOWN) WERE USED AND THERE WERE ACCURACY ISSUES WITH ALL OF THE DEVICES USED WITH THE TRUDI SYSTEM DURING THE ENTIRE PROCEDURE. THE HEALTHCARE PROFESSIONAL REPORTED THAT THE ACCURACY ISSUE WAS OFF FROM THE START OF THE PROCEDURE. THE DEVICES WERE RE-REGISTERED TWO OR THREE TIMES WITHOUT RESOLUTION. THE DEVICES WERE DISPLAYED ON THE TRUDI SYSTEM AS 3 ¿ 4MM OFF. THE PROCEDURE WAS ABLE TO BE COMPLETED WITHOUT ANY NEGATIVE IMPACT TO THE PATIENT. THE DEVICES ARE REPORTEDLY NOT AVAILABLE TO BE RETURNED. ON 21-NOV-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT WHEN THE ACCURACY ISSUE WAS OBSERVED, THE ICON ON THE TRUDI SYSTEM WAS GREEN. THERE WAS NO ERROR MESSAGE ON THE TRUDI NAV MONITOR FOR THE DEVICE. THE DEVICES WERE PLUGGED IN INITIALLY AFTER FIRST REGISTRATION BUT WERE ALREADY PLUGGED IN FOR N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15840773 ↗
• MalfunctionNov 21, 2022Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY STANDARD FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE WITH BALLOON SINUPLASTY, THE FOLLOWING DEVICES WERE USED: A 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / LOT#: UNKNOWN), A 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN / LOT# UNKNOWN), AND AN UNKNOWN CURVE SUCTION DEVICE (CATALOG / LOT# UNKNOWN) WERE USED AND THERE WERE ACCURACY ISSUES INTERMITTENTLY THROUGHOUT THE CASE ON ALL THREE DEVICES. THE HEALTHCARE PROFESSIONAL REPORTED THAT THE ACCURACY ISSUE WAS OFF FROM THE START OF THE PROCEDURE. THE EMITTER PAD WAS CHECKED WITHOUT RESOLUTION. THE TRUDI SYSTEM WAS RESTARTED BY DOING A FULL SHUTDOWN, THE PATIENT WAS RE-REGISTERED, AND THE REGISTRATION TECHNIQUE WAS CHANGED ¿ THE ACCURACY ISSUE WAS REPORTEDLY BETTER, BUT STILL OFF. IT WAS REPORTED THAT THE REGISTRATION TECHNIQUE WAS CHANGED BECAUSE THEY HAD ORIGINALLY USED A MINI COMPUTERIZED AXIAL TOMOGRAPHY (CAT) SCAN INSTEAD OF A FULL CAT SCAN. ALL DEVICES WERE SHOWN GREEN ON THE TRUDI SYSTEM. THE PROCEDURE WAS COMPLETED WITHOUT RESOLUTION. THERE WAS NO NEGATIVE PATIENT IMPACT. THE DEVICES ARE REPORTEDLY NOT AVAILABLE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15837825 ↗
• MalfunctionNov 17, 2022Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STANDARD REVISION FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE ON (B)(6) 2022, THE FOLLOWING DEVICES WERE USED: TRUDI CURETTE (TDC0005 / LOT# UNKNOWN), 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / LOT#: UNKNOWN), 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN / LOT# UNKNOWN), A TRUDI PROBE (CATALOG / LOT# UNKNOWN), AND A CURVE SUCTION DEVICE (CATALOG / LOT# UNKNOWN). THERE WERE CONSTANT ACCURACY ISSUES ON THE TRUDI SYSTEM WITH ALL OF THE DEVICES ABOUT HALFWAY THROUGH THE PROCEDURE. THE DEVICES WERE RE-REGISTERED A FEW TIMES AND THE ISSUE WOULD TEMPORARILY BE RESOLVED, AND AS THE CASE PROCEEDED, THE ISSUE WOULD RECUR. IT WAS REPORTED THAT THE EMITTER PAD HAD MOVED SLIGHTLY AND THE PATIENT¿S HEAD HAD MOVED A FEW TIMES THROUGHOUT THE PROCEDURE; IT WAS NOTED THAT THE PATIENT WAS IN A REVERSE TRENDELENBURG AND ANGLED TO THE PHYSICIAN. THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED ON THE SAME DAY FOLLOWING THE PROCEDURE AND THE PATIENT WENT TO THE EMERGENCY ROOM (ER) ON (B)(6) 2022, DUE TO A CEREBROSPINAL FLUID (CSF) LEAK. INFORMATION RELATED TO THE PATIENT¿S SYMPTOMS AND H

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15820207 ↗
• MalfunctionNov 11, 2022Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE PRIMARY BALLOON SINUPLASTY (BSP) PROCEDURE, THE FIRST 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN / 220719D-PC) WAS BENT. IT WAS REPLACED WITH ANOTHER 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN / 220727D-PC) AND THEN IT WAS REPORTED THAT THE PHYSICIAN FELT THAT THE NAVIGATED BALLOON WAS INACCURATE. THE BALLOON WAS REPLACED ONCE MORE AND THE PROCEDURE WAS CONTINUED AND SUBSEQUENTLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT OR PATIENT INJURY. ON (B)(6) 2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE ACCLARENT REPRESENTATIVE IS NOT SURE WHICH OF THE BALLOONS (FROM LOT 220719D-PC OR 220727D-PC) HAS THE BENT AND WHICH BALLOON WAS REPORTED TO HAVE THE INACCURATE NAVIGATION. THE BALLOON THAT THAT WAS REPORTED TO BE BENT, THE BENT WAS AT THE DISTAL TIP; THE BALLOON CATHETER WAS NOT KINKED. THE PATIENT¿S ANATOMY DID NOT FACTOR INTO THE REPORTED ISSUE. THE ACCURACY ISSUE WAS OBSERVED WHEN THE TRUDI ICON WAS GREEN. THERE WAS NO ERROR MESSAGE ON THE TRUDI NAVIGATION MONITOR. IT IS NOT KNOWN IF THE DEVICE WAS PLUGGED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15785069 ↗
• InjuryNov 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 61-YEAR-OLD MALE PATIENT WITH A HISTORY OF HYPERTENSION, HIGH CHOLESTEROL AND PAST SMOKING UNDERWENT A BALLOON SINUPLASTY (BSP) PROCEDURE ON (B)(6) 2022 THAT WAS TARGETING THE FRONTAL AND SPHENOID SINUSES. AFTER THE PROCEDURE, IN THE RECOVERY ROOM, THE PATIENT STARTED TO COMPLAINT OF PAIN IN THE FOREHEAD AND SUFFERED AN ASTHMA ATTACK. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL VIA AMBULANCE. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL; THERE WAS NO COMPLAINT OF PAIN DURING THE PROCEDURE. THE PROCEDURE WENT WELL AND PER THE PHYSICIAN, THE PATIENT WAS FEELING WELL AND WAS GOING TO BE DISCHARGED THE SAME DAY AS THE PROCEDURE. AT THE TIME OF REPORTING, IT WAS REPORTED THAT THE DEVICE USED WAS A NAVIGATED SPINPLUS BALLOON, HOWEVER, PRODUCT INFORMATION INCLUDING LOT NUMBER WAS NOT AVAILABLE. ON 24-OCT-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN / 220512A-PC) WAS USED. THE PATIENT HAS A HISTORY OF ASTHMA AND IS PRESCRIBED AN ALBUTEROL INHALER. THE INFORMATION INDICATED THAT THE EMERGENT MEDICAL REASON FOR THE PATIE

  Patient problems: Asthma; Pain

  MAUDE report 15723486 ↗
• MalfunctionJul 29, 2022Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE PRIMARY BALLOON SINUPLASTY (BSP) PROCEDURE, THE WIRE OF THE 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN / 220523C-PC) WAS INACCURATELY DISPLAYED ON THE TRUDI SYSTEM. THE PATIENT WAS REGISTERED WITHOUT RESOLUTION. THE BALLOON WAS REPLACED AND THE ISSUE WAS RESOLVED. ON 16-JUL-2022, ADDITIONAL INFORMATION WAS PROVIDED. THE ADDITIONAL INFORMATION INDICATED THAT WHEN THE ACCURACY ISSUE WAS OBSERVED, THE ICON ON THE TRUDI SYSTEM WAS GREEN. THERE WAS NO ERROR MESSAGE ON THE TRUDI NAV MONITOR FOR THE DEVICE. THE DEVICE WAS PLUGGED IN AFTER REGISTRATION. THE PATIENT TRACKER DID NOT MOVE. THE PATIENT TRACKER CABLE WAS NOT UNDER TENSION IN RELATION TO THE REPORTED EVENT. ONLY ONE COMPUTED TOMOGRAPHY (CT) SCAN WAS ATTEMPTED TO BE USED WITH THE DEVICE; THE CT IMAGE USED WAS THE PRIMARY IMAGE. THE NUMBER OF SLICES ON THE CT SCAN IS NOT KNOWN. THE REPORTED INACCURACY ISSUE WAS DETERMINED BY THE PHYSICIAN THAT IT WAS NOT CLOSE TO WHERE HE WAS ON THE ANATOMY. THE INACCURACY WAS NOT WITHIN 2MM. THERE WAS NO FERROMAGNETIC MATERIAL PLACED WITHIN THE TRUDI ZONE. THE CROSSHAIRS DID NOT TURN YELLOW. NEITHER T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136521 ↗
• MalfunctionJun 27, 2022Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE PRIMARY BALLOON SINUPLASTY (BSP) PROCEDURE, THE ACCURACY OF THE 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM ((B)(4)) WAS OFF BY 2 CENTIMETERS DURING THE TREATMENT IN THE SPHENOID SINUS. THE BALLOON HAS NOT BEEN PREVIOUSLY INFLATED. THE DEVICE WAS USED WITH A ZERO DEGREE SCOPE. THERE WAS NO NON-ACCLARENT DEVICES USED. THE DEVICE WAS REPLACED AND THE REPORTED ISSUE WAS RESOLVED; THE PROCEDURE RESUMED WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 16-JUN-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT WHEN THE REPORTED ACCURACY ISSUE WAS OBSERVED, THE ICON ON THE TRUDI SYSTEM WAS GREEN. THERE WAS NO ERROR MESSAGE ON THE TRUDI NAV MONITOR. THE INFORMATION INDICATED THAT THE DEVICE WAS PLUGGED IN AFTER REGISTRATION. THE PATIENT TRACKER WAS NOT MOVED AND THE TRACKER CABLE WAS NOT UNDER TENSION IN RELATION TO THIS ACCURACY ISSUE. NO MORE THAN ONE COMPUTED TOMOGRAPHY (CT) SCAN WAS ATTEMPTED TO BE USED WITH ONE DEVICE. THE CT SCAN CONTAINS OVER 250 SLICES. THE REPORTED INACCURACY ISSUE WAS DETERMINED VIA VISUAL CONFIRMATION OF A NON-MOV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14830983 ↗
• MalfunctionDec 1, 2021Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE REVISION PRIMARY BALLOON SINUPLASTY (BSP) PROCEDURE, DURING THE TREATMENT OF BILATERAL FRONTAL AND MAXILLARY SINUSES, THE ACCURACY OF THE 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN / 201111A-PC) WAS OFF BY ¿SEVERAL MILLIMETERS.¿ THE PATIENT WAS REGISTERED THREE TIMES WITHOUT RESOLUTION. MAGNETIC INTERFERENCE WAS CHECKED. THE ¿DONGLE¿ WAS REPLACED WITHOUT RESOLUTION. THE 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM WAS REPLACED WITH A NON-NAVIGATION LIGHTED BALLOON AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS SUCCESSFULLY CONTINUED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ADDITIONAL INFORMATION WAS RECEIVED ON 16 NOV 2021. THE INFORMATION INDICATED THAT WHEN THE ACCURACY ISSUE WAS OBSERVED, ALL THE ICONS ON THE TRUDI SYSTEM WERE GREEN. THERE WAS NO ERROR MESSAGE ON THE TRUDI NAV MONITOR FOR THE DEVICE. THE INFORMATION INDICATED THAT IT IS NOT KNOWN IF THE DEVICE WAS PLUGGED IN BEFORE OR AFTER REGISTRATION (I.E., USING THE REGISTRATION PROBE); IT IS POSSIBLE THAT IT WAS PLUGGED IN AFTER BUT THIS IS NOT CONCLUSIVE. THE PATIENT TRACKER WAS NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12910740 ↗
• MalfunctionNov 10, 2021Unsealed Device Packaging; Unsealed Device Packaging

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ON (B)(6) 2021, THE 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN / 210209A-PC) WAS PULLED FOR A CASE, AND AT THE TIME THE DURING THE PROCEDURE PREP, IT WAS NOTED THAT THE OUTER PACKAGING SEAL WAS ¿BARELY¿ BREACHED WHICH RAISED STERILITY CONCERNS; AS A RESULT, THE BALLOON WAS NOT USED. IT WAS REPORTED THAT IT IS THE INNER PRODUCT POUCH (REFERRING TO THE WHITE PACKAGING WITH THE PRODUCT LABEL THAT COVERS THE STERILE CLEAR BALLOON CONTAINER AND THE BALLOON) THAT HAS THE ALLEGED DAMAGED / COMPROMISED SEAL. THERE WAS NO DAMAGE ON THE SHIPPING BOX, THE OUTER PRODUCT BOX WAS NOT DAMAGED. THERE WAS NO PATIENT ADVERSE EVENT; THE PRODUCT WAS NOT USED AFTER IT WAS NOTICED THAT THE SEAL WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12789755 ↗
• MalfunctionAug 4, 2021Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE PRIMARY BALLOON SINUPLASTY (BSP) PROCEDURE, IT WAS REPORTED THAT THERE WAS A ¿GROSS SYSTEM INACCURACY¿ WITH THE 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN / 210303B-PC). IT WAS REPORTED THAT THEY REGISTERED THE PATIENT WITH THE NAVIGATION SYSTEM AND ¿VERIFIED THE ACCURACY OF THE SYSTEM¿ AND ¿OBSERVED A SUBSTANTIAL INACCURACY AGAINST KNOWN ANATOMICAL STRUCTURES.¿ THERE WERE TWO ATTEMPTS AT RE-REGISTRATION WITHOUT RESOLUTION. THE TRUDI SYSTEM WAS REBOOTED WITHOUT RESOLUTION. THE PROCEDURE WAS CONTINUED WITH A NON-NAVIGATIONAL BALLOON. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ADDITIONAL INFORMATION WAS RECEIVED ON 26 JULY 2021. THE INFORMATION INDICATED THAT WHEN THE ISSUE WAS OBSERVED, THE ICON ON THE TRUDI SYSTEM WAS GREEN. THERE WAS NO ERROR MESSAGE ON THE TRUDI NAV MONITOR FOR THE DEVICE. THE PATIENT TRACKER WAS NOT MOVED NOR WAS THE PATIENT TRACKER CABLE UNDER TENSION IN RELATION TO THIS EVENT. THERE WAS NOT MORE THAN ONE COMPUTED TOMOGRAPHY (CT) SCAN ATTEMPTED TO BE USED WITH ONE DEVICE. THE CT IMAGE WAS USED AS THE PRIMARY IMAGE. THERE WAS NO FERROMAGNETIC M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12277947 ↗
• MalfunctionMar 23, 2021Material Rupture; Material Rupture

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE PRIMARY BALLOON SINUPLASTY (BSP) PROCEDURE ON (B)(6) 2021, THE 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN / 201124A-PC) WAS USED. THE MAXILLARY SINUS WAS BEING TREATED WHEN THE BALLOON SUDDENLY BURST AT 8 ATM ON THE SECOND INFLATION. THE BALLOON WAS REPLACED WITH ANOTHER 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON FROM THE SAME LOT AND THE REPLACEMENT ALSO BURST SUDDENLY ON THE FIRST INFLATION AT 8ATM. THE BALLOON CATHETER WAS REPLACED FOR A THIRD TIME AND THE REPLACEMENT BALLOON WAS SUCCESSFULLY USED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICES WERE RETURNED FOR EVALUATION. DURING THE VISUAL INSPECTION OF ONE OF THE TWO BALLOON CATHETERS, THERE WAS EVIDENCE OF A RADIAL BURST OBSERVED. BASED ON THE PRODUCT ANALYSIS ON 19 MARCH 2021, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11555651 ↗
• MalfunctionJan 19, 2021Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE PRIMARY BALLOON SINUPLASTY (BSP) PROCEDURE TARGETING ALL SIX SINUSES, THERE WERE INACCURACIES IN THE GUIDANCE OF THE GUIDEWIRE OF THE 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN / 200904A-PC) WHEN THE PHYSICIAN WAS MANEUVERING IT INSIDE THE SINUS. TO TROUBLESHOOT, THE BALLOON WAS RE-REGISTERED, THE PATIENT TRACKER WAS RESEATED, AND THE PHYSICIAN TRIED A DIFFERENT SINUS, AND CONFIRMED WITH THE REGIONAL SALES SPECIALIST THAT ALL TROUBLESHOOTING WAS COMPLETED. THE BALLOON WAS REPLACED, AND THE ISSUE WAS RESOLVED; THE PROCEDURE WAS CONTINUED. IT WAS REPORTED THAT THE TRUDI SYSTEM IS OPERATING PER SPECIFICATION AND IS NOT RESPONSIBLE FOR THE REPORTED PRODUCT ISSUE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 21 DECEMBER 2020, ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT THE ICON ON THE TRUDI SYSTEM WAS GREEN, THERE WAS NO ERROR MESSAGE. THE DEVICE WAS PLUGGED IN AFTER REGISTRATION. THE PATIENT TRACKER DID NOT MOVE, AND THE PATIENT TRACKER CABLE WAS NOT UNDER TENSION IN RELATION TO THE REPORTED INACCURACIES. THERE WAS NO MORE THAN ONE COMPUTED TOMOGRAPHY (CT) SC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11198004 ↗