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	Micturition Urgency (1871); Dysuria (2684); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	01/11/2022
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 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.
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of january 11, 2022, was chosen as the best estimate based on the procedure which happened sometime in 2022 and ten (10) days post-procedure (pod10) ed presentation for urgency and difficulty urinating with foley catheter likely due to bladder spasms.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 e1301 captures the reportable event of dysuria.Patient code e1605 captures the reportable event of muscle spasms causing difficulty urinating.Impact code f2303 captures the reportable event of medication required.Impact code f23 captures the reportable event of unexpected medical intervention.

• 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: 18932469
• Report Number: 2124215-2024-16002
• Device Sequence Number: 11890592
• 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
• Report Date (Section B): 03/19/2024

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): Initial
• Initial Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 03/19/2024
• 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; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Race: White