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	Hematuria (2558); Dysuria (2684)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 e1302 captures the reportable event of hematuria.Patient code e1301 captures the reportable event of dysuria.Impact code f12 captures the reportable event of serious injury.
Event or Problem Description
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.
Event or Problem Description
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 not serious, was probably 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 (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 e1302 captures the reportable event of hematuria.Patient code e1301 captures the reportable event of dysuria.Impact code f12 captures the reportable event of serious injury.

• 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: 18926940
• Report Number: 2124215-2024-15975
• Device Sequence Number: 4449718
• 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
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 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: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: Asian