Piranha M0065051600Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 08714729302599), received between Mar 19, 2019 and Feb 10, 2026 — classified as 2 deaths, 19 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (12 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026

  PHYSICIAN WAS DOING KIDNEY BIOPSIES. AFTER SECOND BIOPSY WAS OBTAINED FORCEPS STOPPED GRASPING. THE POTENTIAL HARM FOR THE PATIENT WAS IF WE COULD NOT FINISH THE CASE OR DID NOT HAVE A BACKUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303847 ↗
• MalfunctionAug 27, 2025Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING A PROCEDURE. REPORTEDLY, THE CUP CANNOT BE OPEN OR CLOSED EVEN WHEN THE HANDLE WAS OPERATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907434 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING A URETEROSCOPY WITH BIOPSY AND ABLATION OF THE RIGHT LOWER CALYX TUMOR PROCEDURE PERFORMED SOMETIME IN 2022. DURING THE PROCEDURE, THE ACQUISITION OF THE BIOPSY SPECIMEN WAS ADEQUATE. POST-PROCEDURE, THE PATIENT BECAME TACHYCARDIC WITH A NEW ATRIAL FLUTTER. THE PATIENT CHOSE TO BE DISCHARGED AGAINST MEDICAL ADVICE (AMA) ONE (1) DAY POST-PROCEDURE (POD01). PER OPERATIVE NOTES, A NON-BOSTON SCIENTIFIC FLEXIBLE URETEROSCOPE WAS USED WITH A NO-TOUCH TECHNIQUE AND FOUND NO LESIONS IN THE URETER. THERE WAS THE BEGINNING OF CARPET-LIKE RED VELVETY TUMORS INVOLVING ONE OF THE LOWER POLE CALYCES. THERE WAS A NARROW MID-CALYX INFUNDIBULUM WITH A NECROTIC TUMOR VISIBLE INSIDE AND AN UPPER POLE THAT APPEARED TO HAVE A DEAD TUMOR AND NO NEW DISEASE. DILATION OF THE MID-CALYX INFUNDIBULUM WAS DONE WITH A DILATING CATHETER TO 10F TO PERMIT ENTRY INTO IT. SELECTIVE CYTOLOGY AND BIOPSY OF THE TUMOR WERE DONE, AND THULIUM LASER ABLATION OF THE TUMOR WAS ACCOMPLISHED. THE NECROTIC UPPER CALYCEAL TUMOR WAS BIOPSIED AND LASER RESECTED AS WELL, BUT THE LOWER CALYX TUMOR WAS EXTENSIVE, AND VISUALIZATION WAS POO

  Patient problems: Atrial Flutter; Tachycardia

  MAUDE report 18935658 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING A CYSTOURETHROSCOPY WITH URETEROSCOPY AND PYELOSCOPY AND FULGURATION OF URETERAL LESION PROCEDURE PERFORMED SOMETIME IN 2021. DURING THE PROCEDURE, THE ACQUISITION OF THE BIOPSY SPECIMEN WAS ADEQUATE. THE PATIENT HAD PERSISTENT HEMATOMA AFTER THE SURGERY. IN ADDITION, THE PATIENT ALSO HAD LOW-GRADE FEVER WHICH WAS LIKELY DUE TO HEMATOMA. 16 DAYS POST-PROCEDURE (POD16), THE PATIENT UNDERWENT SURGICAL MANAGEMENT (NEPHROURETERECTOMY). PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS SERIOUS, WAS POSSIBLY RELATED TO THE DEVICE, AND PROBABLY RELATED TO THE PROCEDURE.

  Patient problems: Fever; Hematoma

  MAUDE report 18933864 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING A RIGHT URETEROSCOPY WITH BIOPSY PROCEDURE PERFORMED SOMETIME IN 2022. DURING THE PROCEDURE, THE ACQUISITION OF THE BIOPSY SPECIMEN WAS ADEQUATE. TWO (2) DAYS POST-PROCEDURE (POD02), THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) FOR HEMATURIA, DISLODGED STENT, AND INCONTINENCE. THESE WERE MANAGED WITH FLOMAX/DITROPAN AND AUGMENTIN COURSES. PER OPERATIVE NOTE, THE SALINE WASH OF THE RIGHT RENAL PELVIS WAS SENT FOR CYTOLOGY AND THEN RANDOM BIOPSIES WERE TAKEN FROM THE UPPER, MID, AND DISTAL URETERS USING PIRANHA BIOPSY FORCEPS. THROUGH THE SHEATH RENAL ENDOSCOPY AND MULTIPLE BIOPSIES. FULGURATION WAS DONE IN THE MUCOSA IN THE RENAL PELVIS AND CALYCES; NO SOLID OR PAPILLARY LESIONS WERE SEEN. RANDOM BLADDER BIOPSIES WERE DONE FROM THE POSTERIOR WALL, RIGHT LATERAL WALL, LEFT LATERAL WALL, AND ANTERIOR WALL. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS SERIOUS, WAS POSSIBLY RELATED TO THE DEVICE, AND CAUSALLY RELATED TO THE PROCEDURE.

  Patient problems: Hematuria; Urinary Incontinence

  MAUDE report 18933646 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING A URETHROPLASTY FOR RECONSTRUCTION OF ANTERIOR URETHRA PROCEDURE PERFORMED SOMETIME IN 2022. DURING THE PROCEDURE, THE ACQUISITION OF THE BIOPSY SPECIMEN WAS ADEQUATE. PER OPERATIVE NOTE, UPON THE PHYSICIAN'S ARRIVAL, A CYSTOSCOPY WAS PERFORMED USING A FLEXIBLE CYSTOSCOPE, AS THIS WAS THE LARGEST CALIBER SCOPE THE PATIENT'S URETHRA WAS ABLE TO ACCOMMODATE. THE BLADDER NECK WAS NORMAL, AND THE URETERAL ORIFICES WERE IN NORMAL ORTHOTOPIC POSITION. A LARGE, APPROXIMATELY 3.5-4CM MASS WAS NOTED ALONG THE RIGHT LATERAL WALL WHICH INCLUDED AREAS OF NECROSIS. THE MASS WAS SESSILE, BROAD-BASED, AND RAISED WITHOUT A SIGNIFICANT PAPILLARY COMPONENT. A BIOPSY OF THE MASS WAS PERFORMED THROUGH THE CYSTOSCOPE USING BIOPSY FORCEPS. TEN DAYS POST-PROCEDURE (POD10), THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) FOR URGENCY AND DIFFICULTY URINATING WITH FOLEY CATHETER. THIS WAS LIKELY DUE TO BLADDER SPASMS. THE PATIENT WAS DISCHARGED WITH A PRESCRIPTION OF OXYBUTYNIN. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS NOT SERIOUS, WAS NOT RELATED TO THE DEVICE, AND CAUSALLY RELATED TO THE PROCEDURE.

  Patient problems: Cramp(s) /Muscle Spasm(s); Dysuria; Micturition Urgency

  MAUDE report 18932469 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING A URETHROPLASTY FOR REPAIR OF MEMBRANOUS URETHRA BY PERINEAL APPROACH PROCEDURE PERFORMED SOMETIME IN 2022. DURING THE PROCEDURE, THE ACQUISITION OF THE BIOPSY SPECIMEN WAS ADEQUATE. PER OPERATIVE NOTE, THERE WERE POLYPOID LESIONS ON THE POSTERIOR BASE OF THE BLADDER. IT WAS UNCLEAR IF THESE LESIONS WERE SECONDARY TO THE SUPRAPUBIC TUBE OR GIVEN THE PATIENT'S HISTORY OF A BLADDER CANCER, THAT THIS WAS A NEW BLADDER CANCER. BECAUSE OF THIS, THE PHYSICIAN ELECTED TO GET BIOPSIES OF THIS. THEY PLACED COLD CUP BIOPSIES THROUGH THE FLEXIBLE CYSTOSCOPE AND OBTAINED MULTIPLE COLD CUP REPRESENTATIVE BIOPSIES OF THIS LESION, WHICH WAS SUBMITTED TO PATHOLOGY. BASED ON PATHOLOGICAL REPORT, THERE WAS ADEQUATE SPECIMEN WITH UROTHELIUM, BUT LOW-GRADE UROTHELIAL CARCINOMA CAN'T BE EXCLUDED. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) TEN (10) DAYS POST-PROCEDURE (POD10) FOR BLADDER SPASMS MANAGED WITH CAPPED URETHRAL FOLEY AND OPEN SUPRAPUBIC TUBE (SPT) AND DITROPAN. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS NOT SERIOUS, WAS POSSIBLY RELATED TO THE DEVICE, AND CAUSALLY RELATED TO THE PROCEDUR

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 18929810 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE SECOND OF TWO EVENTS REPORTED BY THE SAME PATIENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING A CYSTOURETHROSCOPY WITH URETEROSCOPY AND RESECTION OF URETERAL TUMOR PROCEDURE PERFORMED SOMETIME IN 2021. DURING THE PROCEDURE, THE ACQUISITION OF THE BIOPSY SPECIMEN WAS ADEQUATE. EIGHT (8) DAYS POST-PROCEDURE (POD08), THE PATIENT HAD AN EMERGENCY DEPARTMENT (ED) VISIT FOR HEMATURIA, CLOT RETENTION, RETENTION AND SUPRAPUBIC DISCOMFORT. THE PATIENT WAS TOLD TO COME TO THE ED FOR CATHETER. AFTER FLUIDS AND SUCCESSFUL TRIAL OF VOID (TOV), THE PATIENT WAS DISCHARGED WITHOUT ADMISSION. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS SERIOUS, WAS PROBABLY RELATED TO THE DEVICE, AND PROBABLY RELATED TO THE PROCEDURE.

  Patient problems: Discomfort; Hematuria; Urinary Retention

  MAUDE report 18927022 ↗
• DeathMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING A CYSTOURETHROSCOPY PROCEDURE PERFORMED SOMETIME IN 2021. DURING THE PROCEDURE, THE PATIENT ALSO UNDERWENT A REMOVAL OF URETHRAL CALCULUS AND FOLEY CATHETER INSERTION. EIGHT (8) DAYS POST-PROCEDURE (POD08), THE PATIENT EXPIRED LIKELY DUE TO A WORSENING CARDIOPULMONARY FUNCTION. BASED ON THE OPERATIVE NOTE, THEY WERE UNSURE HOW PIRANHA BIOPSY FORCEPS WERE USED. NO BIOPSY WAS TAKEN. JUST STONE PROCEDURE AND OPERATIVE FOLEY PLACEMENT IN THE PATIENT IN URINARY RETENTION. THE PATIENT WAS DECEASED OF UNKNOWN CAUSE ON POD08 WITHOUT AUTOPSY. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS SERIOUS, WAS NOT RELATED TO THE DEVICE, AND POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 18927021 ↗
• DeathMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING A CYSTOURETHROSCOPY WITH URETEROSCOPY AND PYELOSCOPY AND LITHOTRIPSY WITH INSERTION OF DOUBLE J STENTS BILATERAL PROCEDURE PERFORMED SOMETIME IN 2020. DURING THE PROCEDURE, THERE WERE NO BIOPSIES TAKEN AND THE PATIENT HAD STENT EXPLANTS. THE PATIENT WAS ADMITTED 18 DAYS POST-PROCEDURE (POD18) FOR ALTERED MENTAL STATUS, ACUTE KIDNEY INJURY (AKI) AND FUNGAL INFECTION. THE PATIENT HAD A LONG HISTORY OF MULTIPLE MYELOMA AND PROGRESSIVELY WORSENING SYMPTOMS. THE PATIENT'S FAMILY DECIDED NOT TO CONTINUE TREATMENT AND PATIENT DIED 24 DAYS POST-PROCEDURE (POD24). PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS SERIOUS, WAS POSSIBLY RELATED TO THE DEVICE, AND POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Renal Failure; Unspecified Infection; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 18926977 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING A RIGHT URETEROSCOPY WITH BIOPSY AND LASER ABLATION OF RIGHT URETER TUMORS PROCEDURE PERFORMED SOMETIME IN 2022. DURING THE PROCEDURE, THE ACQUISITION OF THE BIOPSY SPECIMEN WAS ADEQUATE. PER OPERATIVE NOTE, THE PHYSICIAN DISCOVERED THREE (3) SMALL TUMORS OF THE MID AND DISTAL URETER WHICH WERE BIOPSIED WITH A PIRANHA BIOPSY FORCEPS. SEVEN DAYS POST-PROCEDURE (POD07), THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) FOR URINARY RETENTION. A CATHETER WAS PLACED, AND THE PATIENT WAS DISCHARGED WITHOUT ADMISSION. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS SERIOUS, WAS NOT RELATED TO THE DEVICE, AND CAUSALLY RELATED TO THE PROCEDURE.

  Patient problems: Urinary Retention

  MAUDE report 18926974 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING A CYSTOURETHROSCOPY WITH URETEROSCOPY AND PYELOSCOPY AND FULGURATION OF URETERAL LESION PROCEDURE PERFORMED SOMETIME IN 2021. DURING THE PROCEDURE, THE ACQUISITION OF THE BIOPSY SPECIMEN WAS ADEQUATE. FOLLOWING THE PROCEDURE, THE PATIENT CONTINUED HAVING ABDOMINAL PAIN AND THE PATIENT'S CREATININE LEVEL WAS RISING. BECAUSE OF THIS, THE PATIENT HAD BILATERAL NEPHROSTOMY TUBES PLACED SIX (6) DAYS POST-PROCEDURE (POD06). THE PATIENT HAD POSSIBLE PERFORATION WITH THE NEPHROSTOMY TUBE PLACEMENT AND PULMONARY EMBOLISM. THE PATIENT HAD A COMPUTED TOMOGRAPHY (CT) SCAN SHOWING PULMONARY EMBOLISM IN THE SAME ADMISSION. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS SERIOUS, WAS POSSIBLY RELATED TO THE DEVICE, AND POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Abdominal Pain; Perforation; Pulmonary Embolism; Renal Failure

  MAUDE report 18926958 ↗
• InjuryMar 18, 2024Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING A LEFT URETEROSCOPY AND BIOPSY PROCEDURE PERFORMED SOMETIME IN 2021. DURING THE PROCEDURE, THE ACQUISITION OF THE BIOPSY SPECIMEN WAS NOT ADEQUATE. ONE (1) DAY POST-PROCEDURE (POD01), THE PATIENT VISITED THE EMERGENCY DEPARTMENT (ED) FOR DYSURIA AND HEMATURIA WHICH WAS A KNOWN COMPLICATION OF THE PROCEDURE. THERE WAS NO INFECTION NOTED AND NO CLOT RETENTION. THE PATIENT WAS DISCHARGED WITHOUT FURTHER MANAGEMENT. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS SERIOUS, WAS PROBABLY RELATED TO THE DEVICE, AND CAUSALLY RELATED TO THE PROCEDURE.

  Patient problems: Dysuria; Hematuria

  MAUDE report 18926940 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING A CYSTOURETHROSCOPY WITH URETEROSCOPY AND PYELOSCOPY AND FULGURATION OF URETERAL LESION PROCEDURE PERFORMED SOMETIME IN 2022. DURING THE PROCEDURE, THE ACQUISITION OF THE BIOPSY SPECIMEN WAS ADEQUATE. THE PHYSICIAN THEN DID GUIDEWIRE PLACEMENT AND URETEROSCOPY WITH A NON-BOSTON SCIENTIFIC URETERORENOSCOPE AND FOUND ONLY ONE (1) TINY LESION OF THE URETER THAT WAS SESSILE AND LOCATED IN THE MID-URETER BELOW AN AREA OF DENSE FIBROSIS. THIS WAS BIOPSIED AND THEN LASER ABLATED WITH A HOLMIUM LASER. THREE (3) DAYS POST-PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) FOR SYMPTOMS OF URINARY TRACT INFECTION (UTI) WHICH WAS MANAGED WITH ORAL ANTIBIOTICS. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS SERIOUS, WAS POSSIBLY RELATED TO THE DEVICE, AND CAUSALLY RELATED TO THE PROCEDURE.

  Patient problems: Urinary Tract Infection

  MAUDE report 18926932 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING A CYSTOURETHROSCOPY WITH RESECTION OF BLADDER TUMOR (2.0 TO 5.0 CM) PROCEDURE PERFORMED SOMETIME IN 2020. DURING THE PROCEDURE, THE ACQUISITION OF THE BIOPSY SPECIMEN WAS ADEQUATE. TWO (2) DAYS POST-PROCEDURE ((B)(4)), THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR MANAGEMENT OF PYELONEPHRITIS AND POSSIBLE POST-PROCEDURE EMPHYSEMATOUS CYSTITIS. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS NOT SERIOUS, WAS POSSIBLY RELATED TO THE DEVICE, AND PROBABLY RELATED TO THE PROCEDURE.

  Patient problems: Urinary Tract Infection

  MAUDE report 18926905 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING A URETEROSCOPY WITH BIOPSY PROCEDURE PERFORMED SOMETIME IN 2020. DURING THE PROCEDURE, THE ACQUISITION OF THE BIOPSY SPECIMEN WAS ADEQUATE. HOWEVER, 28 DAYS POST-PROCEDURE, THE PATIENT EXPERIENCED HEMATURIA AND CLOTS. THE CT SCAN INDICATED AN "INFILTRATIVE MASS," BUT IT WAS LIKELY DUE TO THE PRIOR BIOPSY. THE PHYSICIAN ASSESSED THE EVENT AS NOT SERIOUS, CAUSALLY RELATED TO BOTH THE DEVICE AND THE PROCEDURE.

  Patient problems: Hematuria

  MAUDE report 18926867 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING A CYSTOURETHROSCOPY WITH URETEROSCOPY AND PYELOSCOPY AND FULGURATION OF URETERAL LESION PROCEDURE PERFORMED SOMETIME IN 2020. DURING THE PROCEDURE, THE ACQUISITION OF THE BIOPSY SPECIMEN WAS ADEQUATE. 28 TO 30 DAYS POST-PROCEDURE ((B)(4)), THE PATIENT HAD A URINARY TRACT INFECTION (UTI) AND WAS ADMITTED. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS SERIOUS, WAS POSSIBLY RELATED TO THE DEVICE, AND CAUSALLY RELATED TO THE PROCEDURE.

  Patient problems: Urinary Tract Infection

  MAUDE report 18926818 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING CYSTOURETHROSCOPY WITH URETEROSCOPY AND PYELOSCOPY AND FULGURATION OF URETERAL LESION PROCEDURE PERFORMED SOMETIME IN 2022. DURING THE PROCEDURE, THE ACQUISITION OF THE BIOPSY SPECIMEN WAS ADEQUATE. NINE (9) DAYS POST-PROCEDURE (POD09), THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) FOR DYSURIA AND WAS GIVEN ORAL ANTIBIOTICS UPON DISCHARGE. PER THE PHYSICIAN'S ASSESSMENT, THE EVENT WAS NOT SERIOUS, POSSIBLY RELATED TO THE DEVICE, AND CAUSALLY RELATED TO THE PROCEDURE.

  Patient problems: Dysuria

  MAUDE report 18926811 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF TWO EVENTS REPORTED BY THE SAME PATIENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING CYSTOURETHROSCOPY AND URETEROSCOPY WITH BIOPSY AND HOLMIUM LASER RESECTION OF LEFT RENAL PELVIS TUMOR PROCEDURE PERFORMED SOMETIME IN 2022. DURING THE PROCEDURE, THE ACQUISITION OF THE BIOPSY SPECIMEN WAS ADEQUATE. 11 DAYS POST-PROCEDURE (POD11), THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) FOR INTERMITTENT CHEST PAIN. THE PATIENT HAD SYMPTOMS SIGNIFICANT FOR UNSTABLE ANGINA STATUS POST CARDIAC CATHETERIZATION SHOWING NONOBSTRUCTIVE DISEASE. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS SERIOUS, WAS NOT RELATED TO THE DEVICE, AND POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Angina; Chest Pain

  MAUDE report 18926173 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING A CYSTOURETHROSCOPY WITH URETEROSCOPY AND PYELOSCOPY AND FULGURATION OF URETERAL LESION PROCEDURE PERFORMED SOMETIME IN 2020. DURING THE PROCEDURE, THE ACQUISITION OF THE BIOPSY SPECIMEN WAS ADEQUATE. NINE (9) DAYS POST-PROCEDURE (POD09) THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) FOR HEMATURIA AND LOWER LIMB EDEMA (LLE). COMPUTED TOMOGRAPHY ARTERIAL PORTOGRAPHY (CTAP) FOUND NO EVIDENCE OF PELVIC THROMBUS AND WITH EVIDENCE OF PROSTATE CANCER WITH METASTATIC LYMPHADENOPATHY. LLE DOPPLER REVEALED NO EVIDENCE OF DEEP VEIN THROMBOSIS (DVT). THE PATIENT WAS DISCHARGED FROM THE ED WITHOUT ADMISSION. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS NOT SERIOUS, WAS POSSIBLY RELATED TO THE DEVICE, AND PROBABLY RELATED TO THE PROCEDURE.

  Patient problems: Hematuria; Swelling/ Edema

  MAUDE report 18926169 ↗
• InjuryMar 18, 2024Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING A CYSTOURETEROSCOPY AND RIGHT URETEROSCOPY WITH URETERAL TUMOR BIOPSY PROCEDURE PERFORMED SOMETIME IN 2022. DURING THE PROCEDURE, THE ACQUISITION OF THE BIOPSY SPECIMEN WAS NOT ADEQUATE. TWO (2) DAYS POST-PROCEDURE, THE PATIENT DEVELOPED ACUTE KIDNEY INJURY (AKI) AND WAS TAKEN BACK TO THE OPERATING ROOM (OR) FOR CYSTOSCOPY AND STENT PLACEMENT FOR AKI BUT WAS UNRESOLVED. COMPUTED TOMOGRAPHY ARTERIAL PORTOGRAPHY (CTAP) SUBSEQUENTLY SHOWED BLOOD CLOTS IN THE RENAL PELVIS. BILATERAL PERCUTANEOUS NEPHROLITHOTOMY (PCN) WAS PLACED THREE DAYS POST-PROCEDURE (POD03). THE AKI CONTINUED TO PROGRESS. THE PATIENT DEVELOPED AN ALTERED MENTAL STATUS (AMS), AND WORSENING ACIDEMIA. THE PATIENT WAS THEN ADMITTED TO THE SURGICAL INTENSIVE CARE UNIT (SICU). THE PATIENT DEVELOPED GROSS HEMATURIA REQUIRING TRANSFUSIONS AND KIDNEY FUNCTION DETERIORATION REQUIRING DIALYSIS. THE PATIENT WAS THEN DISCHARGED 33 DAYS (POD33) FROM THE FACILITY. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS SERIOUS, WAS PROBABLY RELATED TO THE DEVICE, AND CAUSALLY RELATED TO THE PROCEDURE.

  Patient problems: Hematoma; Hematuria; Renal Failure; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 18925885 ↗
• MalfunctionJun 27, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA WAS USED IN A BIOPSY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE JAWS WERE OPENED BUT UNABLE TO CLOSE. THERE WAS NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17207874 ↗
• MalfunctionJun 5, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA FORCEPS WAS TO BE USED IN A PROSTATE BIOPSY PROCEDURE ON (B)(6) 2023. DURING THE UNPACKING, AS PER THE CUSTOMER'S FEEDBACK, THE FORCEPS BECAME CONTAMINATED DUE TO THE PACKAGING CAUSING IT TO SPRING OUT. NO PATIENTS WERE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17066397 ↗
• MalfunctionJun 2, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED IN A BLADDER BIOPSY PROCEDURE ON (B)(6) 2023. DURING THE PROCEDURE, AN ODD CLICKING NOISE WAS HEARD WHEN THE JAWS WAS TRIED TO CLOSE. THE JAWS THEN STAYED OPEN AND WOULDN'T CLOSE. THE WIRE OUTSIDE THE PATIENT WAS THEN CUT AND THE STRING INSIDE WAS PULLED TO CLOSE THE JAWS. THE DEVICE WAS THEN REMOVED INTACT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049216 ↗
• MalfunctionApr 10, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA WAS USED IN A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, THE DEVICE WAS NOT CLOSING APPROPRIATELY. THE PROCEDURE WAS CANCELED BECAUSE THE HOSPITAL DID NOT HAVE ANOTHER BIOPSY FORCEPS. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16706602 ↗