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	Angina (1710); Chest Pain (1776)
Date of Event	01/12/2022
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 and 11 days post-procedure (pod11) ed presentation for intermittent chest pain.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 e061201 captures the reportable event of angina.Patient code e233001 captures the reportable event of chest pain.Impact code f12 captures the reportable event of serious injury.
Event or Problem Description
Note: this manufacturer report pertains to the first of two events reported by the same patient.It was reported to boston scientific corporation that a piranha biopsy forceps was used during cystourethroscopy and ureteroscopy with biopsy and holmium laser resection of left renal pelvis tumor procedure performed sometime in 2022.During the procedure, the acquisition of the biopsy specimen was adequate.11 days post-procedure (pod11), the patient presented to the emergency department (ed) for intermittent chest pain.The patient had symptoms significant for unstable angina status post cardiac catheterization showing nonobstructive disease.Per physician's assessment, the event was serious, was not related to the device, and possibly related to the procedure.
Additional Manufacturer Narrative
Block h11: block a6 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 january 12, 2022, was chosen as the best estimate based on the procedure which happened sometime in 2022 and 11 days post-procedure (pod11) ed presentation for intermittent chest pain.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 e061201 captures the reportable event of angina.Patient code e233001 captures the reportable event of chest pain.Impact code f12 captures the reportable event of serious injury.
Event or Problem Description
Note: this manufacturer report pertains to the first of two events reported by the same patient.It was reported to boston scientific corporation that a piranha biopsy forceps was used during cystourethroscopy and ureteroscopy with biopsy and holmium laser resection of left renal pelvis tumor procedure performed sometime in 2022.During the procedure, the acquisition of the biopsy specimen was adequate.11 days post-procedure (pod11), the patient presented to the emergency department (ed) for intermittent chest pain.The patient had symptoms significant for unstable angina status post cardiac catheterization showing nonobstructive disease.Per physician's assessment, the event was serious, was not related to the device, and possibly 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: 18926173
• Report Number: 2124215-2024-15575
• Device Sequence Number: 19961651
• 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?: 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
• 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: 66 YR
• Patient Sex: Male
• Patient Race: White