MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PIRANHA; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number	M0065051600
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Hematoma (1884); Renal Failure (2041); Hematuria (2558); Unspecified Mental, Emotional or Behavioural Problem (4430)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of january 1, 2022, was chosen as the best estimate based on the procedure which happened sometime in 2022.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: patient code e130501 captures the reportable event of acute kidney injury.Patient code e0505 captures the reportable event of hematoma.Patient code e1302 captures the reportable event of hematuria.Patient code e0206 captures the reportable event of altered mental status.Impact code f08 captures the reportable event of prolonged hospitalization.Impact code f1901 captures the reportable event of additional surgery.Impact code f0801 captures the reportable event of patient admitted to sicu.Impact code f23 captures the reportable event of unexpected medical intervention.Impact code f2302 captures the reportable event of blood transfusion.
Event or Problem Description
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.
Additional Manufacturer Narrative
Block h11: blocks h6 and h10 have been corrected.Block b3: the exact event onset date is unknown.The provided event date of january 1, 2022, was chosen as the best estimate based on the procedure which happened sometime in 2022.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: patient code e130501 captures the reportable event of acute kidney injury.Patient code e1302 captures the reportable event of hematuria.Patient code e0206 captures the reportable event of altered mental status.Impact code f08 captures the reportable event of prolonged hospitalization.Impact code f1901 captures the reportable event of additional surgery.Impact code f0801 captures the reportable event of patient admitted to sicu.Impact code f23 captures the reportable event of unexpected medical intervention.Impact code f2302 captures the reportable event of blood transfusion.
Additional Manufacturer Narrative
Block h11: block b5 has been updated based on the additional information received on (b)(6), 2024.Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2022, was chosen as the best estimate based on the procedure which happened sometime in 2022.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: patient code e130501 captures the reportable event of acute kidney injury.Patient code e1302 captures the reportable event of hematuria.Patient code e0206 captures the reportable event of altered mental status.Impact code f08 captures the reportable event of prolonged hospitalization.Impact code f1901 captures the reportable event of additional surgery.Impact code f0801 captures the reportable event of patient admitted to sicu.Impact code f23 captures the reportable event of unexpected medical intervention.Impact code f2302 captures the reportable event of blood transfusion.
Event or Problem Description
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 of inadequate biopsy specimen was not serious, and the event of aki was serious.Both events were probably related to the device, and causally related to the procedure.

• Brand Name: PIRANHA
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18925885
• Report Number: 2124215-2024-15297
• Device Sequence Number: 19968702
• Product Code: FCL
• UDI-Device Identifier: 08714729302599
• UDI-Public: 08714729302599
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0065051600
• Device Catalogue Number: 505-160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 03/20/2024; 04/10/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 03/20/2024; 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Race: White