UroLift UL400-4 (UDI 00814932020001)Recalls & reported problems

Summary

The FDA's MAUDE database contains 144 adverse event reports that list this exact device (DI 00814932020001), received between Sep 16, 2016 and Sep 2, 2022 — classified as 9 deaths, 106 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Fracture” (25 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 18, 2026.

Recalls naming this device

1. Jun 24, 2022Class IIOpen, Classified

   There is the potential that during implant deployment, the device may not properly deliver a implant.

   Z-1502-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 144 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2022Fracture; Fracture

  ON 30 JUNE 2022, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2022. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS RELEASED WITHOUT A CATHETER AFTER A SUCCESSFUL VOID TRIAL. HOWEVER, IT WAS NOTED THAT TWO DEVICES DID NOT PROPERLY DEPLOY AN IMPLANT. INVESTIGATION OF ONE OF THE RETURNED DEVICES ON 4 AUGUST 2022 IDENTIFIED THAT LESS THAN 1MM OF THE NEEDLE TIP WAS MISSING AND UNACCOUNTED FOR. THE PHYSICIAN WAS INFORMED BUT DID NOT PROVIDE DETAILS REGARDING PATIENT FOLLOW-UP. NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353260 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, NEOTRACT WAS MADE AWARE OF A PUBLISHED CLINICAL ARTICLE THAT REPORTED A PATIENT WHO UNDERWENT A PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON AN UNSPECIFIED DATE. FOLLOWING THE PROCEDURE, THE PATIENT REQUIRED SELF-CATHETERIZATION AND WAS REPORTED TO HAVE DEVELOPED RECURRENT URINARY TRACT INFECTIONS, TREATED WITH ORAL ANTIBIOTICS. THE PATIENT IS REPORTED TO HAVE DEVELOPED SHORTNESS OF BREATH AND ACTIVITY INTOLERANCE THAT RESOLVED WITH REST, AND EXPERIENCED WEIGHT LOSS SECONDARY TO DECREASED APPETITE. UPON FURTHER EVALUATION BY CARDIOLOGIST, HE WAS FOUND TO HAVE TACHYCARDIA AND BILATERAL LOWER EXTREMITY EDEMA. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR CONGESTIVE HEART FAILURE AND TREATED WITH IV DIURETICS. DURING THIS HOSPITALIZATION, HE WAS DIAGNOSED WITH INFECTIVE ENDOCARDITIS, TREATED WITH IV ANTIBIOTICS AND REQUIRED MITRAL AND AORTIC VALVE REPLACEMENT. THE PATIENT WAS REPORTED AS HAVING A NEAR COMPLETE RETURN TO BASELINE HEALTH.

  Patient problems: Heart Failure/Congestive Heart Failure; Urinary Retention; Urinary Tract Infection

  MAUDE report 15256840 ↗
• InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, NEOTRACT WAS MADE AWARE OF A PATIENT WITH A PAST MEDICAL HISTORY OF HEMOPHILIA THAT RECEIVED A PROSTATIC URETHRAL LIFE (PUL) ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE, ONE IMPLANT FAILED TO PROPERLY DEPLOY, AND THE PHYSICIAN INSTRUCTED THE PATIENT THAT HE WOULD PASS A PORTION OF THE IMPLANT IN HIS URINE. POST PROCEDURE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PELVIC PAIN AND HEMATURIA. ON (B)(6) 2022, NEOTRACT RECEIVED ADDITIONAL INFORMATION FROM THE PATIENT, WHO REPORTED THAT HE WAS ADMITTED TO THE HOSPITAL FROM 24-28 JUNE 2021 AND MANAGED WITH MEDICATION AND CATHETERIZATION. UPON DISCHARGE THE CATHETER WAS REMOVED AND THE PATIENT WAS ABLE TO VOID. THE PATIENT FURTHER REPORTED BEING HOSPITALIZED FROM 7-12 JULY 2021 FOR HEMATURIA AND TREATED WITH MEDICATION. THE PATIENT ALSO UNDERWENT AN ULTRASOUND WHICH IDENTIFIED A MISFIRED URETHRAL ENDPIECE. RIGID CYSTOSCOPY WAS PERFORMED TO REMOVE THE CLIP WITH BIOPSY GRASPERS. NO SIGNIFICANT BLEEDING WAS REPORTED. THE PATIENT REPORTED THAT ON (B)(6) 2021, HE PRESENTED TO THE EMERGENCY DEPARTMENT FOR PAIN, HEMATURIA, AND POOR FLOW, BUT WAS DISCHARGED WITH NO SPECIFIC INTERVENTION SPECIFIED. THE PATIENT REPOR

  Patient problems: Hematuria; Pain

  MAUDE report 15108039 ↗
• DeathJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 23 MAY 2022, NEOTRACT BECAME AWARE OF A 92 YEAR-OLD PATIENT, WITH A HISTORY OF HYPERTENSION AND CARDIAC ARRHYTHMIA, WHO UNDERWENT A SUCCESSFULLY COMPLETED PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2022. POST PROCEDURE, THE PATIENT STAYED OVERNIGHT AT THE HOSPITAL FOR HIS COMFORT AND WAS RELEASED THE NEXT DAY WITHOUT A CATHETER, WAS URINATING WELL AND WITH NO INTERCURRENCE. IT WAS REPORTED THAT PATIENT DIED IN HIS SLEEP ON (B)(6) 2022. IT WAS REPORTED VIA THE MEDICAL REPORT THAT THE PATIENT¿S MEDICATION WAS CHANGED FROM RITMONORM TO AMIODARONE 200 ML/DAY, AND THE PATIENT DIED DUE TO HIS COMORBIDITIES. THE PHYSICIAN STATED HE DOES NOT BELIEVE THE PROCEDURE CAUSED THE PATIENT¿S DEATH.

  Patient problems: Cardiac Arrest

  MAUDE report 14761703 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, NEOTRACT WAS MADE AWARE OF A PATIENT THAT HAD RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT EXPERIENCED DIZZINESS AND WEAKNESS. ON (B)(6) 2022, HE PRESENTED TO THE HOSPITAL DUE TO ONGOING SYMPTOMS WHERE HE RECEIVED A BLOOD TRANSFUSION OF 2 UNITS DUE TO A HEMATOMA. NO ADDITIONAL INTERVENTIONS OCCURRED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2022. DURING A FOLLOW UP APPOINTMENT ON (B)(6) 2022, THE PATIENT WAS REPORTED AS DOING FINE.

  Patient problems: Hematoma

  MAUDE report 14686551 ↗
• MalfunctionMar 29, 2022Fracture; Fracture

  ON 12 JANUARY 2022, NEOTRACT WAS MADE AWARE OF A PATIENT WHO HAD RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT A DEVICE DID NOT PROPERLY DEPLOY. ON (B)(6) 2022, INVESTIGATION OF THE RETURNED DEVICE CONFIRMED THAT A 33MM NEEDLE FRAGMENT WAS MISSING AND UNACCOUNTED FOR. THE PHYSICIAN WAS INFORMED BUT NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13943656 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 29 NOVEMBER 2021, NEOTRACT WAS MADE AWARE OF A PUBLISHED ARTICLE WHICH DESCRIBED A PATIENT WHO UNDERWENT A PROSTATIC URETHRAL LIFT (PUL) PROCEDURE FIFTY MONTHS AFTER UNDERGOING AN INFLATABLE PENILE PROSTHESIS PROCEDURE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UROSEPSIS WITHIN 90 DAYS OF THE PUL PROCEDURE, WHICH WAS MANAGED WITH FLUIDS AND IV ANTIBIOTICS. IT WAS REPORTED THE PATIENT WAS HOSPITALIZED FOR FIVE DAYS. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Sepsis

  MAUDE report 13019408 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 17-NOVEMBER-2021, NEOTRACT WAS MADE AWARE OF A PUBLISHED ARTICLE WHICH DESCRIBED A PATIENT THAT UNDERWENT A PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON AN UNSPECIFIED DATE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEMATURIA WHICH REQUIRED ENDOSCOPIC HEMOSTATIC INTERVENTION. THE DETAILS OF THE INTERVENTION WERE NOT SPECIFIED, BUT IT WAS REPORTED THE PATIENT WAS HOSPITALIZED FOR THREE DAYS. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Hematuria

  MAUDE report 13014656 ↗
• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(4) 2021, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) ON (B)(6) 2021. POST PROCEDURE, IT WAS REPORTED THAT THE PATIENT WAS BLEEDING FROM THE DORSAL VEIN COMPLEX, RESULTING FROM A BONE STRIKE, AND REQUIRED SUTURE LIGATION AND TRANSFUSION. IT WAS REPORTED THE PATIENT WAS HOSPITALIZED FOR A WEEK. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Hematoma

  MAUDE report 12969224 ↗
• InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2021. AS A PRE-PROCEDURAL ANTIBIOTIC, THE PATIENT WAS PRESCRIBED ANCEF. IN THE DAYS FOLLOWING THE PROCEDURE (TIMING UNKNOWN), THE PATIENT UNDERWENT EMERGENCY HEMORRHOID SURGERY WHICH UROLOGIST SAID WAS ¿UNRELATED TO THE PUL PROCEDURE.¿ POST HEMORRHOID SURGERY, THE PATIENT EXPERIENCED URINARY RETENTION. ON (B)(6) 2021, HE WAS ADMITTED TO THE HOSPITAL FOR A C. DIFFICILE INFECTION, THOUGHT TO BE RELATED TO THE ANCEF MEDICATION AND NOT TO THE PUL PROCEDURE. CT IMAGING REVEALED AIR IN HIS PELVIS. PATIENT WAS TRANSFERRED TO THE ICU FOR TWO WEEKS FOR UNKNOWN REASONS, HAS SINCE BEEN DISCHARGED AND REPORTED AS DOING WELL. THE UROLOGIST STATED THAT HE BELIEVED THE INFECTION, URINARY RETENTION, AND PELVIC AIR WERE UNRELATED TO THE PUL PROCEDURE.

  Patient problems: Bacterial Infection; Urinary Retention

  MAUDE report 12849499 ↗
• MalfunctionOct 28, 2021Fracture; Fracture

  ON (B)(6) 2021, NEOTRACT WAS MADE AWARE OF A PATIENT THAT RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL). ON (B)(6) 2021, DURING THE DEVICE INVESTIGATION, IT WAS NOTED THAT APPROXIMATELY 1MM OF THE NEEDLE TIP WAS MISSING AND UNACCOUNTED FOR. THE PHYSICIAN WAS NOTIFIED AND ON 20 OCT 2021, IT WAS REPORTED THAT THE PATIENT WAS DOING GENERALLY WELL. THE PATIENT INITIALLY REPORTED PAIN AFTER THE PROCEDURE, WHICH THE PHYSICIAN ATTRIBUTED TO NERVES SURROUNDING THE IMPLANT SITE. SINCE THE PATIENT¿S PAIN LESSENED, THE PHYSICIAN DID NOT PLAN TO BRING THE PATIENT BACK FOR ADDITIONAL EXAMINATION.

  Patient problems: Pain

  MAUDE report 12715805 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 27 SEPT 2021, NEOTRACT WAS MADE AWARE OF A PATIENT THAT HAD RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) ON AN UNSPECIFIED DAY IN (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED GROSS HEMATURIA, AND HE PRESENTED TO THE ER ON (B)(6) 2021. ADDITIONAL INFORMATION WAS RECEIVED ON 30 SEPT 2021 THAT THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR BLOOD CLOT REMOVAL AND CAUTERIZATION ON (B)(6) 2021 AND DISCHARGED ON (B)(6) 2021. THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: Hematuria

  MAUDE report 12694514 ↗
• MalfunctionOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, NEOTRACT WAS MADE AWARE OF A PATIENT THAT RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL). ON 30 SEPT 2021, IT WAS ADDITIONALLY REPORTED THAT DURING THE PROCEDURE, AN UNSPECIFIED LENGTH OF NEEDLE FROM THE DELIVERY DEVICE BROKE OFF DURING THE IMPLANT DEPLOYMENT. THE PHYSICIAN REMOVED THE ENTIRE LENGTH OF THE NEEDLE FRAGMENT FROM THE PATIENT¿S BLADDER AND CONTINUED THE PROCEDURE. NO PATIENT HARM OR ADVERSE EVENTS WERE REPORTED WITH THE RETRIEVAL OR PROCEDURE, AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12694297 ↗
• InjuryOct 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 9 SEPT 2021, NEOTRACT WAS MADE AWARE OF A PATIENT THAT DEVELOPED AN INFECTION AFTER A SUCCESSFULLY COMPLETED PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2021. PRIOR TO PUL, THE PATIENT DID NOT HAVE A URINALYSIS PERFORMED, BUT WAS PRESCRIBED CIPROFLOXACIN AS A PROPHYLACTIC PRE-PROCEDURAL ANTIBIOTIC. POST PROCEDURE, HE WAS PRESCRIBED LEVAQUIN FOR FIVE DAYS. AT AN UNDETERMINED TIME LATER, THE PATIENT PRESENTED TO THE ER WITH A UTI (CULTURING STRAIN OF KLEBSIELLA PNEUMONIAE). A URINE CULTURE WAS PERFORMED INDICATING THE UTI WAS RESISTANT TO CIPROFLOXACIN AND LEVAQUIN, AND THE PATIENT SUBSEQUENTLY DEVELOPED SEPSIS. HE WAS ADMITTED TO THE HOSPITAL FOR FOUR DAYS AS HE RECEIVED IV ANTIBIOTICS. HE WAS REPORTED TO BE DOING WELL. THE UROLOGIST PERFORMED FOUR (4) PUL PROCEDURES ON (B)(6) 2021 AND ALL PATIENTS DEVELOPED INFECTIONS. IT IS NOT SUSPECTED THAT THE INFECTION WAS CAUSED BY THE DEVICE.

  Patient problems: Sepsis

  MAUDE report 12602235 ↗
• InjuryOct 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, NEOTRACT WAS MADE AWARE OF A PATIENT THAT DEVELOPED AN INFECTION AFTER A SUCCESSFULLY COMPLETED PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2021. PRIOR TO PUL, THE PATIENT DID NOT HAVE A URINALYSIS PERFORMED, BUT WAS PRESCRIBED CIPROFLOXACIN AS A PROPHYLACTIC PRE-PROCEDURAL ANTIBIOTIC. POST PROCEDURE, HE WAS PRESCRIBED LEVAQUIN FOR FIVE DAYS. AT AN UNDETERMINED TIME LATER, THE PATIENT PRESENTED TO THE ER WITH A UTI (CULTURING STRAIN OF KLEBSIELLA PNEUMONIAE). A URINE CULTURE WAS PERFORMED INDICATING THE UTI WAS RESISTANT TO CIPROFLOXACIN AND LEVAQUIN. IT WAS REPORTED THAT HE RECEIVED IV ANTIBIOTICS, AND HE WAS DISCHARGED HOME THE SAME DAY. HE WAS REPORTED TO BE DOING WELL. THE UROLOGIST PERFORMED (4) PUL PROCEDURES ON (B)(6) 2021 AND ALL PATIENTS DEVELOPED INFECTIONS. IT IS NOT SUSPECTED THAT THE INFECTION WAS CAUSED BY THE DEVICE.

  Patient problems: Urinary Tract Infection

  MAUDE report 12602207 ↗
• InjuryOct 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 9 SEPT 2021, NEOTRACT WAS MADE AWARE OF A PATIENT THAT DEVELOPED AN INFECTION AFTER A SUCCESSFULLY COMPLETED PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2021. PRIOR TO PUL, THE PATIENT DID NOT HAVE A URINALYSIS PERFORMED, BUT WAS PRESCRIBED CIPROFLOXACIN AS A PROPHYLACTIC PRE-PROCEDURAL ANTIBIOTIC. POST PROCEDURE, HE WAS PRESCRIBED LEVAQUIN FOR FIVE DAYS. AT AN UNDETERMINED TIME LATER, THE PATIENT PRESENTED TO THE ER WITH EPIDIDYMITIS AND A UTI (CULTURING STRAIN OF E. COLI). WHILE IN THE ER, A URINE CULTURE WAS PERFORMED INDICATING THE UTI WAS RESISTANT TO CIPROFLOXACIN AND LEVAQUIN. HE RECEIVED IV ANTIBIOTICS, AND HE WAS DISCHARGED HOME THE SAME DAY. HE WAS REPORTED TO BE DOING WELL. THE UROLOGIST PERFORMED (4) PUL PROCEDURES ON (B)(6) 2021 AND ALL PATIENTS DEVELOPED INFECTIONS. IT IS NOT SUSPECTED THAT THE INFECTION WAS CAUSED BY THE DEVICE.

  Patient problems: Urinary Tract Infection

  MAUDE report 12602194 ↗
• InjuryOct 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, NEOTRACT WAS MADE AWARE OF A PATIENT THAT DEVELOPED AN INFECTION AFTER A SUCCESSFULLY COMPLETED PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2021. PRIOR TO PUL, A PATIENT¿S URINALYSIS RETURNED POSITIVE FOR A UTI, AND HE WAS PRESCRIBED CIPROFLOXACIN. NO URINE CULTURE WAS PERFORMED PRE-PROCEDURE. POST PROCEDURE, HE WAS PRESCRIBED LEVAQUIN FOR FIVE DAYS. AT AN UNDETERMINED TIME LATER, THE PATIENT PRESENTED TO THE ER WITH A UTI. A URINE CULTURE WAS PERFORMED INDICATING THE UTI (CULTURING STRAIN OF E. COLI) WAS RESISTANT TO CIPROFLOXACIN, AND HE RECEIVED IV ANTIBIOTICS. HE WAS DISCHARGED HOME THE SAME DAY, AND HE WAS REPORTED TO BE DOING WELL. THE UROLOGIST PERFORMED (4) PUL PROCEDURES ON (B)(6) 2021 AND ALL PATIENTS DEVELOPED INFECTIONS. IT IS NOT SUSPECTED THAT THE INFECTION WAS CAUSED BY THE DEVICE.

  Patient problems: Urinary Tract Infection

  MAUDE report 12602172 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 15 JULY 2021, NEOTRACT WAS MADE AWARE OF A PATIENT WHO UNDERWENT A SUCCESSFULLY COMPLETED PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2021. PATIENT HAD A PRIOR HISTORY OF AN ARTIFICIAL HEART VALVE AND BIOPROSTHETIC HEART VALVE, AND HAD STOPPED ANTICOAGULANT THERAPY FOR ONE WEEK PRIOR TO THE PROCEDURE. DURING RECOVERY, THE PATIENT DEVELOPED WORSENING ABDOMINAL PAIN AND BECAME HYPOTENSIVE. HE WAS ADMITTED AFTER A CT SCAN CONFIRMED A LARGE PELVIC HEMATOMA. NEOTRACT RECEIVED FURTHER INFORMATION ON 22 JULY 2021 THAT THE PATIENT HAD REQUIRED A BLOOD TRANSFUSION DUE TO DECREASING HEMOGLOBIN LEVELS WHILE HOSPITALIZED. IT WAS ALSO REPORTED THAT THE BLEEDING RESOLVED AND HIS CATHETER WAS REMOVED PRIOR TO DISCHARGE ON (B)(6) 2021. TWO DAYS LATER, HE WAS READMITTED DUE TO SHORTNESS OF BREATH AND DIAGNOSED WITH A NEW ONSET OF PULMONARY EMBOLISM REQUIRING HEPARIN DRIP AND A NEW ANTICOAGULANT THERAPY. THE PATIENT WAS DISCHARGED ON (B)(6) 2021 AND REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Hematoma

  MAUDE report 12443893 ↗
• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, NEOTRACT WAS MADE AWARE OF A PATIENT WHO UNDERWENT A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) DESPITE ONE IMPLANT NOT DEPLOYING PROPERLY. ON (B)(6) 2021, ADDITIONAL DETAILS WERE PROVIDED BY THE PHYSICIAN THAT THE PATIENT HAD RETURNED TO THE HOSPITAL FOR A SIGNIFICANT BOWEL OBSTRUCTION AND LATER RETURNED AGAIN AND RECEIVED A LAPAROSCOPIC EXPLORATORY PROCEDURE WHERE A CAPSULAR TAB WAS ALLEGEDLY FOUND EMBEDDED IN THE SMALL BOWEL TISSUE AND WAS SUBSEQUENTLY REMOVED. THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12380979 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, NEOTRACT WAS MADE AWARE OF A (B)(6) YEAR OLD PATIENT WITH A PAST MEDICAL HISTORY OF ACUTE PROSTATITIS, RENAL CALCULUS, GERD, DEPRESSION, HYPERCHOLESTEROLEMIA, KIDNEY STONES, MELANOMA, AND HYPERLIPIDEMIA WHO UNDERWENT A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) ON (B)(6) 2021. POST PROCEDURE, THE PATIENT EXPERIENCED CONSTIPATION FOR FIVE DAYS. ON (B)(6) 2021, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SEPSIS AND A RASH, WHERE HE RECEIVED IV ANTIBIOTICS AND STEROIDS. THE PHYSICIAN NOTED THAT THE PATIENT MAY HAVE AN UNKNOWN NICKEL ALLERGY. ON (B)(6) 2021, THE PATIENT WAS DISCHARGED WITH ORAL STEROIDS AND WAS REPORTED AS DOING WELL.

  Patient problems: Rash; Sepsis

  MAUDE report 12363617 ↗
• InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 14 JULY 2021, NEOTRACT WAS MADE AWARE OF A PATIENT THAT RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) ON (B)(6) 2021. THE PATIENT WAS ON ANTICOAGULATION MEDICATION WHICH WAS HELD PRIOR TO THE PROCEDURE. ON (B)(6) 2021, NEOTRACT RECEIVED ADDITIONAL INFORMATION THAT WHEN THE PATIENT RESTARTED THE ANTICOAGULATION MEDICINE ON (B)(6) 2021, HE EXPERIENCED HEMATURIA AND WAS HOSPITALIZED FOR APPROXIMATELY THREE DAYS AS HE UNDERWENT CONTINUOUS BLADDER IRRIGATION. THE PATIENT SUBSEQUENTLY RETURNED TO THE HOSPITAL AND WAS TAKEN TO THE OR FOR REMOVAL OF BLOOD CLOTS. IT WAS REPORTED THE PATIENT WAS DISCHARGED WITH A FOLEY CATHETER AND WAS DOING WELL.

  Patient problems: Hematuria

  MAUDE report 12332518 ↗
• InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 12 JULY 2021, NEOTRACT WAS MADE AWARE OF A PATIENT THAT RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL). IN POST-PROCEDURE RECOVERY, IT WAS DISCOVERED THAT THE PATIENT HAD DEVELOPED A HEMATOMA AND HE WAS ADMITTED. THE PHYSICIAN SURGICALLY REPAIRED THE BLEEDING ARTERY AND THE PATIENT REQUIRED BLOOD TRANSFUSION. THE PATIENT WAS RELEASED FROM THE HOSPITAL AFTER FIVE DAYS AND WAS REPORTED TO BE STABLE AND IMPROVING.

  Patient problems: Hematoma

  MAUDE report 12305114 ↗
• DeathAug 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 9 JULY 2021, NEOTRACT WAS MADE AWARE OF A PUBLISHED ARTICLE THAT INCLUDED DETAILS OF A PATIENT WHO REPORTEDLY EXPERIENCED AN INFECTION WITHIN 30 DAYS OF A PROSTATIC URETHRAL LIFT (PUL) PROCEDURE, WHICH EVENTUALLY LED TO THE PATIENT PASSING ON AN UNSPECIFIED DATE. THE ARTICLE MENTIONED THAT SEPSIS WAS A CONTRIBUTING FACTOR TO THE PATIENT DEATH, BUT DID NOT SPECIFICALLY LINK THE SEPSIS EVENT TO THE PUL PROCEDURE. NEOTRACT HAS NO ADDITIONAL INFORMATION ON THE PATIENT¿S MEDICAL HISTORY OR COMORBIDITY FACTORS THAT LED TO THIS INCIDENT.

  Patient problems: Sepsis

  MAUDE report 12284996 ↗
• InjuryJul 29, 2021Failure to Cut; Failure to Cut

  ON (B)(6) 2021, NEOTRACT WAS MADE AWARE OF A PATIENT TAKING ANTICOAGULATION MEDICATION WHO UNDERWENT A PROSTATIC URETHRAL LIFT (PUL) PROCEDURE. IT WAS REPORTED THAT TWO OF THE DEPLOYED IMPLANTS DID NOT FULLY TENSION LEAVING EXCESS SUTURE IN THE URETHRA CAUSING BLEEDING AND CLOTS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2021 STATED THAT THE PHYSICIAN HAD ATTEMPTED TO REMOVE THE EXCESS SUTURE DURING THE TREATMENT BUT FELT THAT REMOVAL MAY CAUSE SIGNIFICANT BLEEDING. AS A RESULT, THE PATIENT WAS HELD OVERNIGHT IN THE HOSPITAL AND TAKEN TO THE OR THE NEXT DAY, WHERE THE PHYSICIAN USED A RESECTOSCOPE WITH LASER TO CUT THE SUTURE. ON (B)(6) 2021, THE PATIENT PRESENTED FOR FOLLOW UP EXPERIENCING PAIN AND MILDLY IMPROVED HEMATURIA. NO FURTHER INFORMATION IS AVAILABLE FOR THE CONDITION OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249224 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 28 JUNE 2021, NEOTRACT WAS MADE AWARE OF A PATIENT WITH A PAST MEDICAL HISTORY OF FREQUENT HEMATOMAS POST- SURGERY, A MECHANICAL HEART VALVE, AND ON ANTICOAGULATION MEDICATION THAT UNDERWENT A PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2021. IT WAS REPORTED THAT TWO DEVICES DID NOT PROPERLY DEPLOY IMPLANTS DURING THE PROCEDURE. NO PATIENT INJURY OR HARM WAS REPORTED. A FEW DAYS POST PROCEDURE, THE PATIENT EXPERIENCED SEVERE ABDOMINAL PAIN AND GROSS HEMATURIA REQUIRING HOSPITALIZATION AND TRANSFUSION. SHORTLY AFTER, THE PATIENT WAS REPORTED TO BE DOING WELL. AT AN UNSPECIFIED TIME LATER, THE PATIENT DEVELOPED A SUBDURAL HEMATOMA WHICH THE UROLOGIST DOES NOT BELIEVE WAS CAUSED BY THE PUL PROCEDURE.

  Patient problems: Hematoma

  MAUDE report 12236124 ↗