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

Model Number	M0065051600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematuria (2558); Urinary Incontinence (4572)
Date of Event	01/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of january 3, 2022, was chosen as the best estimate based on the procedure which happened sometime in 2022 and two (2) days post-procedure (pod02) ed presentation for hematuria, dislodged stent, and incontinence.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Patient code e1302 captures the reportable event of hematuria.Impact code f12 captures the reportable event of serious injury.Impact code f2303 captures the reportable event of medication required.
Event or Problem Description
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.
Event or Problem Description
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, a dislodged non-boston scientific 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 not serious, was possibly related to the device, and causally related to the procedure.
Additional Manufacturer Narrative
Block h11: block b5 has been updated based on the additional information received on april 10, 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 and two (2) days post-procedure (pod02) ed presentation for hematuria, dislodged non-boston scientific stent, and incontinence.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 e1302 captures the reportable event of hematuria.Impact code f12 captures the reportable event of serious injury.Impact code f2303 captures the reportable event of medication required.
Additional Manufacturer Narrative
Block h11: blocks a3b, b5, h2, and h11 have been updated based on the additional information received on may 28, 2024.Block b3: the exact event onset date is unknown.The provided event date of january 3, 2022, was chosen as the best estimate based on the procedure which happened sometime in 2022 and two (2) days post-procedure (pod02) ed presentation for hematuria, dislodged non-boston scientific stent, and incontinence.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 e1302 captures the reportable event of hematuria.Impact code f12 captures the reportable event of serious injury.Impact code f2303 captures the reportable event of medication required.
Event or Problem Description
It was reported 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, a dislodged non-boston scientific 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, multiple biopsies and 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 of dislodged non-boston scientific stent was not serious, was not related to the device, and causally related to the procedure.The event of hematuria was not serious, was possibly related to the device and causally related to the procedure.The event of incontinence was not serious, was possibly 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: 18933646
• Report Number: 2124215-2024-16003
• Device Sequence Number: 9346850
• 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): 06/24/2024

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?: No
• 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: 04/10/2024; 05/28/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/23/2024; 06/24/2024
• 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: Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Race: White