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	Fever (1858); Hematoma (1884)
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 january 1, 2021, was chosen as the best estimate based on the procedure which happened sometime in 2021.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 e0505 captures the reportable event of hematoma.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 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.

• 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: 18933864
• Report Number: 2124215-2024-16006
• Device Sequence Number: 18478197
• 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
• Patient Age: 69 YR
• Patient Sex: Female