UROLIFT IPN924184Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10814932020343), received between May 4, 2023 and Sep 8, 2026 — classified as 1 death, 17 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668890 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 50212471 ↗
• MalfunctionApr 3, 2025Fracture; Fracture

  ON JANUARY 29, 2025, NEOTRACT HAS BEEN MADE AWARE THAT ¿DURING A PROSTATIC URETHRAL LIFT (PUL) PROCEDURE, THE FIRST IMPLANT FAILED TO DEPLOY. THE PHYSICIAN REPORTED THAT THE IMPLANT MISFIRED, AND THE ENTIRE DEVICE HAD TO BE REMOVED AS THE HANDLE WAS NOT FUNCTIONING. ACCORDING TO A NEOTRACT REPRESENTATIVE PRESENT DURING THE PROCEDURE, THERE WAS A NOTABLE AMOUNT OF BLEEDING AS THE PHYSICIAN EXTRACTED THE DEVICE. THE PHYSICIAN USED GRASPERS TO REMOVE THE IMPLANT AND OPENED A NEW HANDLE TO COMPLETE THE PROCEDURE SUCCESSFULLY.¿ ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 05, 2025, INDICATED THAT ¿ACCORDING TO THE PHYSICIAN, THE NEEDLE WOULD NOT GO BACK IN, WHICH IS WHY THE HANDLE DID NOT WORK. THE PATIENT'S BLEEDING RESOLVED OVER THE WEEKEND, AND NO INTERVENTION WAS NEEDED.¿ ON MARCH 07, 2025, THE INVESTIGATION OF THE RETURNED SAMPLE FOUND THAT 3MM OF THE NEEDLE WAS NOT RETURNED WITH THE DEVICE. FURTHER ADDITIONAL INFORMATION RECEIVED ON MARCH 19, 2025, INDICATED THAT ¿THERE WAS A SMALL FRAGMENT OF THE NEEDLE THAT WAS REMOVED FROM THE PATIENT.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21763619 ↗
• MalfunctionMar 31, 2025Misfire; Misfire

  ON JANUARY 28, 2025, NEOTRACT HAS BEEN MADE AWARE THAT ¿A 72 YEAR OLD MALE PATIENT WITH A 36 GRAM PROSTATE AND NO KNOWN PRE-EXISTING UROLOGICAL CONDITIONS, UNDERWENT AN IN-OFFICE PROCEDURE THAT WAS PERFORMED UNDER A PROSTATE BLOCK AND NITROUS GAS. DURING THE FIRST IMPLANT ATTEMPT, THE PHYSICIAN FOLLOWED THE STANDARD TECHNIQUE, STARTING AT THE BLADDER NECK, ANGLING THE HANDLE AT 10 O¿CLOCK WITH 5¿10 DEGREES OF COMPRESSION, AND PULLING THE TRIGGER THREE TIMES, BUT NO SUTURE WAS VISIBLE IN THE KEYHOLE. FOLLOWING GUIDANCE, HE WITHDREW THE DEVICE AND PERFORMED THE FOURTH PULL ON THE SIDE TABLE, BUT NO IMPLANT WAS RELEASED. THE BACK OF THE CARTRIDGE WAS CHECKED, AND NO BUCKLE WAS FOUND. A SECOND ATTEMPT WITH A NEW CARTRIDGE FOLLOWED THE SAME STEPS, YIELDING THE SAME RESULT. A THIRD ATTEMPT WITH A NEW HANDLE, WITH CAREFUL HAND MOVEMENTS, ALSO FAILED. OBSERVING BOTH THE PHYSICIAN¿S HANDS AND THE SCREEN, THE REPRESENTATIVE CONFIRMED PROPER TECHNIQUE WAS FOLLOWED. AFTER ABORTING THE PROCEDURE, AN INVESTIGATION ON THE SIDE TABLE SHOWED THAT ALL THREE CARTRIDGE INDICATORS WERE RECESSED AS IF AN IMPLANT HAD BEEN PLACED. WHEN RUNNING THROUGH THE FOUR TRIGGER PULLS ON SPENT CARTRIDGES, THE CAPSUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21732117 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON FEBRUARY 05, 2025, NEOTRACT HAS BEEN MADE AWARE THAT ¿A PATIENT UNDERWENT A UROLIFT PROCEDURE IN WHICH FIVE IMPLANTS WERE PLACED AND WAS DISCHARGED TO HOME WITH A CATHETER. THE NIGHT POST-PROCEDURE THE PATIENT PASSED OUT AND SOUGHT MEDICAL ATTENTION. UPON EVALUATION, IT WAS OBSERVED THAT THE PATIENT HAD SIGNIFICANT PELVIC BLEEDING DUE TO PELVIC HEMATOMA. THE PATIENT RECEIVED BLOOD TRANSFUSIONS AS PART OF THE TREATMENT.¿

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21510612 ↗
• MalfunctionJan 23, 2025

  THE SURGEON WAS PERFORMING SURGERY AND USING THE UROLIFT 2 IMPLANT CARTRIDGE, AND IT MISFIRED. THE CARTRIDGE WAS REMOVED FROM THE FIELD AND REPLACED WITH A NEW DEVICE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21216772 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OCTOBER 7, 2024, NEOTRACT HAS BEEN MADE AWARE THAT ¿A PATIENT REQUIRED MULTIPLE PROCEDURES AND SEVERAL ER VISITS. THE PROCEDURE WAS STANDARD, WITH FOUR IMPLANTS PLACED IN THE CORRECT LOCATIONS. THE PATIENT LATER PRESENTED TO THE ER WITH URINARY RETENTION AND SUBSEQUENTLY RETURNED WITH A HEMATOMA. THE PATIENT WAS TREATED WITH A PAE (PROSTATIC ARTERY EMBOLIZATION) AND HAD TO UNDERGO SURGERY DUE TO CONTINUED BLEEDING." ADDITIONAL INFORMATION RECEIVED ON OCTOBER 22, 2024, INDICATED THAT A NEOTRACT REPRESENTATIVE WAS INFORMED OF THE EVENT ON (B)(6) 2024. THE UROLIFT PROCEDURE WAS PERFORMED IN JULY, EXACT DATE WAS NOT PROVIDED. TWO DAYS POST-PROCEDURE, THE PATIENT DEVELOPED A PELVIC HEMATOMA. ON THE FIRST NIGHT FOLLOWING THE PROCEDURE, THE PATIENT RETURNED TO THE EMERGENCY ROOM DUE TO URINARY RETENTION AND WAS CATHETERIZED. THE NEXT NIGHT, THE PATIENT WAS READMITTED WITH A SEVERE PELVIC HEMATOMA. TREATMENT INCLUDED PROSTATIC ARTERY EMBOLIZATION (PAE), AN OPEN LAPAROTOMY, AND A BLOOD TRANSFUSION. THE PATIENT¿S CURRENT CONDITION IS STABLE.

  Patient problems: Hematoma

  MAUDE report 20518629 ↗
• InjuryOct 10, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ON AUGUST 16, 2024, NEOTRACT WAS MADE AWARE BY A PHYSICIAN, VIA A DOCMATTER DISCUSSION THREAD TITLED ¿NICKEL ALLERGY DEVELOPED POST UROLIFT. BEST WAY TO REMOVE ALL IMPLANTS?¿, THAT ¿PHYSICIAN HAVE A 50 YEAR OLD MALE WHO DEVELOPED A GENERALIZED MILD RASH AFTER UROLIFT. NO OTHER NEW MEDS OR CONDITIONS THAT WERE SUGGESTIVE OF A CAUSE, THEREFORE, THE PHYSICIAN URGED HIM TO GO GET ALLERGY TESTED. PATIENT COME BACK ALLERGIC TO MOST METALS INCLUDING NICKEL. PATIENT HAS NEVER HAD THIS ISSUE BEFORE AND WAS WELL INFORMED, AS PATIENT IS ACTUALLY A CLINICAL TRIAL PATIENT. PATIENT WOULD LIKE ALL THE CLIPS REMOVED. WHAT'S THE BEST WAY OF REMOVING ALL THE CLIPS (INCLUDING THE CAPSULAR TAB WHERE THE NICKEL IS LOCATED) AND THE LEAST INVASIVE / LEAST TRAUMATIC MANNER?¿ ADDITIONAL INFORMATION RECEIVED ON JULY 30, 2024, INDICATED THAT THE PATIENT PARTICIPATED IN THE UROLIFT IMPACT STUDY AND UNDERWENT A PUL PROCEDURE USING THE UL2 DEVICE. THE RASH WAS DESCRIBED AS INTERMITTENT, AND THE PATIENT TOOK BENADRYL TO ALLEVIATE SYMPTOMS. FURTHER CLARIFICATION RECEIVED ON THE SAME DATE (JULY 30, 2024) DESCRIBED THE PATIENT'S SYMPTOMS AS MORE OF AN ITCHY SENSATION RATHER THAN A RASH, BEGINNING TWO WEEKS POST-PRO

  Patient problems: Itching Sensation; Rash

  MAUDE report 20419245 ↗
• MalfunctionOct 10, 2024Fracture; Fracture

  ON AUGUST 16, 2024, NEOTRACT HAS BEEN MADE AWARE THAT ¿TWO UL2CHK HAD SEPARATE ISSUES FROM THE SAME LOT NUMBER. ONE WAS OPENED AND THE ALUMINUM PART OF THE SHAFT ON THE HANDLE WAS BENT. THE OTHER ONE STOPPED WORKING AFTER A FEW IMPLANTS WERE DELIVERED AND JAMMED UP.¿ THE PROCEDURE WAS COMPLETED, AND NO ADVERSE EVENT WAS REPORTED IN THE PATIENT. ON SEPTEMBER 10, 2024, THE INVESTIGATION OF ONE OF THE DEVICES REVEALED THAT THE NEEDLE TIP WAS BROKEN AND APPROXIMATELY 2MM OF NEEDLE TIP MATERIAL WAS MISSING AND NOT RETURNED WITH THE DEVICE. THE PHYSICIAN WAS INFORMED ABOUT THE BROKEN NEEDLE FRAGMENT, BUT NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20419112 ↗
• DeathSep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AUGUST 29, 2024, A PHYSICIAN REPORTED TO NEOTRACT THE FOLLOWING: A PATIENT HAD GONE TO THE EMERGENCY ROOM WITH LOWER ABDOMINAL PAIN THE EVENING AFTER HIS UROLIFT PROCEDURE ON (B)(6) 2024. THE PATIENT WAS ADMITTED TO EMERGENCY DEPARTMENT AFTER A CT SCAN SHOWED A SMALL PELVIC HEMATOMA. AN INFERIOR VENA CAVA (IVC) FILTER WAS PLACED BY INTERVENTIONAL RADIOLOGY ON (B)(6) 2024. EMERGENCY DEPARTMENT DISCHARGED THE PATIENT ON (B)(6) 2024. ON (B)(6) 2024, THE REPORTING PHYSICIAN TOLD NEOTRACT THAT THE PATIENT HAD DIED DUE TO A PULMONARY EMBOLISM (PE). THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED BY NEOTRACT FROM THE REPORTING PHYSICIAN ON (B)(6) 2024: THE PATIENT HAD SUCCESSFULLY COMPLETED AN UNCOMPLICATED UROLIFT PROCEDURE ON (B)(6) 2024, WITH NO APPARENT COMPLICATIONS AND MINIMAL BLEEDING OBSERVED. AFTER COMPLETING THE UROLIFT, THE PHYSICIAN ALSO REMOVED KIDNEY STONES, AND A CATHETER WAS PLACED. THE PATIENT WAS 68 YEARS OLD WITH A PROSTATE SIZE OF 41CC. PROSTATE ANATOMY INCLUDED A HIGH MEDIAN BAR AND BULKY, ASYMMETRICAL TISSUE/LOBES THAT INDICATED THE USE OF AN ADVANCED TECHNIQUE CATHETER (ATC). THE PATIENT HAD BEEN HOSPITALIZED FROM (B)(6) 2024, FOR A PE AND HAD STARTED ELIQUIS T

  Patient problems: Insufficient Information

  MAUDE report 20327169 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, NEOTRACT HAS BEEN MADE AWARE THAT ¿A PATIENT RECEIVED 5 UROLIFT IMPLANTS. NOTHING OUT OF THE ORDINARY AND DISCHARGED THE SAME DAY. THE PATIENT RETURNED THE NEXT DAY AFTER FAINTING AND A CT SCAN REVEALED PROSTATIC ARTERY EMBOLUS (PAE). THE PATIENT RECEIVED 2 UNITS OF BLOOD AND WAS REPORTED TO BE STABLE. THE PATIENT HAS HEART HISTORY. THE APPROXIMATE SIZE OF THE PROSTATE WAS 40CC. THIS DID NOT OCCUR DURING THE TREATMENT OF A MEDIAN LOBE¿. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024, CONFIRMED THAT PAE REFERS TO PROSTATIC ARTERY EMBOLUS AND THAT THE PATIENT RETURNED TO THE ER THE DAY AFTER THE PROCEDURE, WHERE THE CT SCAN WAS PERFORMED. FURTHER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024, INDICATED THAT THE PATIENT HAD FAINTED THE DAY AFTER THE PROCEDURE AND WAS HOSPITALIZED FOR AT LEAST THREE DAYS. A BLOOD TRANSFUSION OF TWO UNITS WAS ADMINISTERED AS PART OF THE TREATMENT. THE PATIENT HAD NO OTHER KNOWN MEDICAL CONDITIONS EXCEPT FOR HEART HISTORY. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Embolism/Embolus; Syncope/Fainting

  MAUDE report 20287612 ↗
• InjuryAug 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED ¿MD STATES PATIENT WAS COMPLAINING OF ABDOMINAL DISCOMFORT WENT TO THE ER, HAD A CT AND IT SHOWED THE IMPLANT IN THE BLADDER. MD IS GOING BACK IN ON TENTATIVE DATE OF (B)(6) TO REMOVE THE CLIP. [PATIENT EXPERIENCED] ABDOMINAL DISCOMFORT, IMPLANT IS TO BE TAKEN OUT ( B)(6) 2024¿. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD ¿RIGHT FLANK PAIN IN WHICH THEY WENT TO CT BUT NOTES STATE PATIENT HAD A KIDNEY STONE AS WELL. PATIENT WAS SENT IN FOR A CYSTO ON 6/17/24 IN WHICH THE IMPLANT WAS CONFIRMED IN THE BLADDER. IMPLANT IS SCHEDULED TO BE REMOVED ON (B)(6) 2024.¿

  Patient problems: Abdominal Pain

  MAUDE report 20056317 ↗
• MalfunctionAug 22, 2024Break; Break

  ON (B)(6) 2024, NEO TRACT WAS INFORMED OF A PATIENT WHO UNDERWENT A PROSTATIC URETHRAL LIFT PROCEDURE THE SAME DAY. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO COMPLETE PULL 4. WHEN THE DEVICE WAS PULLED OUT FROM THE SHEATH, A BLUE NEEDLE WAS STILL STICKING OUT. THE PROCEDURE WAS COMPLETED, AND NO OTHER ADVERSE EVENTS WERE REPORTED. ON 29 JULY 2024, A PRELIMINARY INVESTIGATION OF THE DEVICE REVEALED A BROKEN NEEDLE SEGMENT AT THE DISTAL END STILL CONNECTED TO THE SUTURE WITH NO MISSING PIECES. THE SECTION OF THE BROKEN NEEDLE WAS APPROXIMATELY 20MM LONG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032350 ↗
• MalfunctionJul 23, 2024Break; Break

  ON 24 JUN 2024, NEO TRACT HAS BEEN MADE AWARE OF A 60 YEAR OLD PATIENT WHO UNDERWENT UL2 PROCEDURE ON THE SAME DAY. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED 3 IMPLANTS, AND DURING THE 4TH IMPLANT DEPLOYMENT THE PHYSICIAN WAS NOT ABLE TO SEE THE SUTURE IN THE KEYHOLE AFTER PULL 3 AND OBSERVED THE NEEDLE TIP BROKEN OFF AND FLOATING IN THE FOSSA. THE PHYSICIAN ATTEMPTED TO PULL THE DELIVERY DEVICE FROM THE PATIENT, BUT HE WAS UNABLE AS THE DEVICE WAS STUCK. AFTER THE PULL 4, THE PHYSICIAN TRIED TO REMOVE THE DEVICE FROM THE PATIENT AND USED GRASPERS TO RETRIEVE THE NEEDLE FROM THE PATIENT. THE PHYSICIAN TRIED TO CUT THE SUTURE WHICH WAS TETHERED TO THE LATERAL LOBE WITH THE BUGBEE, BUT IT WAS UNSUCCESSFUL, SO THE PHYSICIAN USED A LASER AND SUCCESSFULLY CUT THE SUTURE. THE PROCEDURE WAS COMPLETED WITH MILD-MODERATE BLEEDING OCCURRENCE TO THE PATIENT AND A CATHETER WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19811716 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 22 APRIL 2024, NEO TRACT WAS INFORMED OF A PATIENT WHO UNDERWENT A PUL PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS UNEVENTFUL, WITH TWO IMPLANTS PLACED. POST-PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH IRRITATION AND WAS BELIEVED TO HAVE A ¿NICK IN THE BLADDER OR A PERFORATED BLADDER¿. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19766217 ↗
• MalfunctionJun 26, 2024Break; Defective Component; Break; Defective Component

  ON 28 MAY 2024, NEO TRACT WAS MADE AWARE OF A 68-YEAR-OLD PATIENT WHO UNDERWENT A PUL PROCEDURE ON THE SAME DAY. THE PHYSICIAN SUCCESSFULLY PLACED THREE IMPLANTS, WHILE THE 4TH AND 5TH WERE UNSUCCESSFUL. AFTER THE 5TH IMPLANT, WHEN THE PHYSICIAN TRIED TO REMOVE THE URETHRAL END PIECE WITH GRASPER, IT WAS OBSERVED THAT THE NEEDLE, URETHRAL END PIECE, AND CAPSULAR TAB STUCK TOGETHER. ALL LOOSE PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY ADVERSE EVENTS REPORTED. ON 24 JUNE 2024, AN INVESTIGATION CARRIED OUT ON DEVICE 3 REVEALED THAT 14 MM OF THE NEEDLE AT THE DISTAL END WAS BROKEN OFF AND RETURNED SEPARATELY, AND THERE WERE NO MISSING FRAGMENTS OF THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19619711 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 28FEB2024 NEO TRACT WAS MADE AWARE OF A 58-YEAR-OLD PATIENT WHO UNDERWENT A PROSTATIC URETHRAL LIFT ON (B)(6) 2024. THE PROCEDURE WAS UNEVENTFUL, WITH FOUR IMPLANTS PLACED ALONG WITH A PRE-PLANNED TRANSURETHRAL INCISION OF THE PROSTATE AS THE PATIENT HAD A HIGH BLADDER NECK. ON 21 FEB 2021, WHILE THE PATIENT WAS STILL IN HOSPITAL, HE SUFFERED SEVERE ABDOMINAL PAIN, DIZZINESS, AND HYPOTENSION. MRI SCAN REVEALED A PELVIC HEMATOMA. THE PATIENT RECEIVED ONE UNIT OF BLOOD TRANSFUSION AND WAS HOSPITALIZED FOR THREE DAYS. ON (B)(6) 2024, THE PATIENT WAS DISCHARGED AND REPORTED TO BE DOING WELL. NO OTHER ADDITIONAL INTERVENTIONS WERE REQUIRED AND HIS POST-OP FOLLOW-UP WAS SCHEDULED FOR 14 MARCH 2024.

  Patient problems: Hematoma; Low Blood Pressure/ Hypotension; Pain

  MAUDE report 18991057 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 12 JAN 2024, NEO TRACT WAS MADE AWARE OF A PATIENT WHO UNDERWENT A PROSTATIC URETHRAL LIFT PROCEDURE ON (B)(6) 2023. A COUPLE OF MONTHS POST-PROCEDURE THE PATIENT EXPERIENCED PAIN AND INCREASED URINARY FREQUENCY AND ON (B)(6) 2024, A CT SCAN REVEALED A HEMATOMA. ON (B)(6) 2024, 50% OF THE HEMATOMA WAS DRAINED PERCUTANEOUSLY WITH THE REST TO BE REABSORBED NATURALLY. THE PATIENT¿S SYMPTOMS RESOLVED, AND NO COMPLAINTS REPORTED TO DATE.

  Patient problems: Hematoma; Pain

  MAUDE report 18741964 ↗
• InjuryFeb 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THE PATIENT UNDERWENT PROSTATIC URETHRAL LIFT PROCEDURE WHICH WAS UNEVENTFUL. POST PROCEDURE, THE SAME DAY, THE PATIENT EXPERIENCED SEVERE PAIN AND WAS DIAGNOSED WITH PELVIC HEMATOMA AND LOW HEMOGLOBIN LEVEL. HE WAS HOSPITALIZED FOR BLOOD TRANSFUSION AND FOR ANGIOGRAPHIC EMBOLIZATION WHICH WAS UNSUCCESSFUL, AND THE PATIENT WAS DISCHARGED. 4-5 DAYS LATER THE PATIENT PRESENTED WITH FEVER AND WAS HOSPITALIZED FOR PRECAUTION. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Hematoma

  MAUDE report 18646796 ↗
• MalfunctionJan 17, 2024Fracture; Fracture

  ON (B)(6) 2023, A PUL PROCEDURE WAS UNDERWAY USING A UL2 DEVICE WHEN THE NEEDLE TIP BROKE OUTSIDE THE PATIENT. THE PATIENT UNDERWENT A CYSTOSCOPY WHICH CONFIRMED NO NEEDLE FRAGMENT INSIDE THE PATIENT. ON 21DEC23, DURING A DEVICE INVESTIGATION, 2 MM OF THE CAPSULAR TAB AND 1 MM OF THE NEEDLE TIP WAS BROKEN. THE PHYSICIAN WAS INFORMED AND WILL MONITOR THE PATIENT AS NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18524412 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 14 DEC 2023 NEO TRACT HAS BEEN MADE AWARE OF A PATIENT WHO UNDERWENT PROSTATIC URETHRAL LIFT PROCEDURE AS A PART OF THE IMPACT TRAIL ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTED THAT AN IMPLANT WAS ¿PROTRUDING INTO OR IN THE BLADDER¿. A CYSTOSCOPY POST PROCEDURE REVEALED TWO IMPLANTS IN THE BLADDER NECK. THEREFORE, ON (B)(6) 2023 TWO MISPLACED/ENCRUSTED IMPLANTS WERE PLANNED TO BE REMOVED. DURING THE PROCEDURE, THE PHYSICIAN OPTED TO RESECT THE BLADDER NECK TO REMOVE ONE OF THE IMPLANTS. THE PATIENT HAD HIS CATHETER REMOVED ON (B)(6) 2023 AFTER 2 FAILED TRAILS OF VOID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502193 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 13 DEC 2023, NEOTRACT WAS MADE AWARE OF A PATIENT THAT RECEIVED A PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2023. ON THE SAME DAY AFTER THE PROCEDURE, THE PATIENT WAS DIAGNOSED WITH A PELVIC HEMATOMA, CONFIRMED BY CT SCAN, AND UNDERWENT EMBOLIZATION. THE PATIENT WAS HOSPITALIZED FOR ONE NIGHT AND WAS DISCHARGED. THE PATIENT STATUS WAS REPORTED TO BE DOING WELL.

  Patient problems: Hematoma

  MAUDE report 18482668 ↗
• MalfunctionJan 9, 2024

  THE SURGEON PLACED THE HANDLE KIT WITH THE CARTRIDGE, AND IT DID NOT WORK AND WAS CONSIDERED A MISFIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18474605 ↗
• MalfunctionJan 9, 2024

  THE SURGEON PLACED THE HANDLE KIT WITH THE CARTRIDGE, AND IT DID NOT WORK AND WAS CONSIDERED A MISFIRE. THERE WAS ANOTHER DEVICE THAT MISFIRED AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18474556 ↗
• MalfunctionDec 26, 2023Fracture; Fracture

  ON (B)(6) 2023, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE THAT DAY. DURING THE PROCEDURE THE IMPLANT WAS SUCCESSFULLY DEPLOYED; HOWEVER, UPON INSPECTION OF THE DEVICE OUTSIDE THE PATIENT, THE NEEDLE TIP BROKE OFF WHEN IT WAS TOUCHED. A CYSTOSCOPY WAS PERFORMED AND CONFIRMED THAT NO NEEDLE FRAGMENT WAS LEFT IN THE PATIENT AND NO PATIENT HARM OR INJURY WAS REPORTED. INVESTIGATION OF THE RETURNED DEVICE ON 20 DEC 2023, CONFIRMED THAT APPROXIMATELY 1MM OF NEEDLE TIP WAS BROKEN BUT WAS INCLUDED WITH THE RETURNED DEVICE, AND THE ENTIRE LENGTH OF THE NEEDLE WAS ACCOUNTED FOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18394285 ↗