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 Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	01/08/2021
Type of Reportable Event	Death
Event or Problem Description
It was reported to boston scientific corporation that a piranha biopsy forceps was used during a cystourethroscopy procedure performed sometime in 2021.During the procedure, the patient also underwent a removal of urethral calculus and foley catheter insertion.Eight (8) days post-procedure (pod08), the patient expired likely due to a worsening cardiopulmonary function.Based on the operative note, they were unsure how piranha biopsy forceps were used.No biopsy was taken.Just stone procedure and operative foley placement in the patient in urinary retention.The patient was deceased of unknown cause on pod08 without autopsy.Per physician's assessment, the event was serious, was not related to the device, and possibly related to the procedure.Additional information received on 23feb2024, there was no mention of biopsy or piranha use in the operative note, nor was there any insurance coding or pathology results to suggest a biopsy was taken.There were no descriptions in the operative note that would suggest any need to use the piranha.Prior to the patient's surgery they were in the intensive care unit (icu) for respiratory distress.The patient had multiple comorbidities including severe cerebral dysfunction following cardiac arrest of unknown etiology.Urology was consulted for obstructive acute kidney injury (aki).The patient was not improving, and the decision was made to make the patient dnr/dni and extubate.It is important to note that the patient died seven days post-procedure (pod07) without autopsy and not eight (8) days post-procedure (pod08) based on this additional information.
Additional Manufacturer Narrative
Block h11: blocks b3 (date of event) and h10 have been corrected.Block b5 has been updated based on the additional information received on february 23, 2024.Block b3: the exact event onset date is unknown.The provided event date of january 8, 2021, was chosen as the best estimate based on the procedure which happened sometime in 2021 and seven (7) days post-procedure (pod07) when the patient expired.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 e0611 captures the reportable event of heart failure.Impact code f02 captures the reportable event of patient death.
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2021, was chosen as the best estimate based on the procedure which happened sometime in 2021 and eight (8) days post-procedure (pod08) when the patient expired.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 e0611 captures the reportable event of heart failure.Impact code f02 captures the reportable event of patient death.
Event or Problem Description
It was reported to boston scientific corporation that a piranha biopsy forceps was used during a cystourethroscopy procedure performed sometime in 2021.During the procedure, the patient also underwent a removal of urethral calculus and foley catheter insertion.Eight (8) days post-procedure (pod08), the patient expired likely due to a worsening cardiopulmonary function.Based on the operative note, they were unsure how piranha biopsy forceps were used.No biopsy was taken.Just stone procedure and operative foley placement in the patient in urinary retention.The patient was deceased of unknown cause on pod08 without autopsy.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: 18927021
• Report Number: 2124215-2024-15977
• Device Sequence Number: 15793840
• 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): 03/20/2024

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: Not provided
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 03/20/2024
• 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; Death
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Race: Black Or African American