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	Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	01/11/2022
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 ten (10) days post-procedure (pod10) ed presentation for bladder spasms managed with capped urethral foley and open spt and ditropan.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 e1605 captures the reportable event of bladder spasm.Impact code f23 captures the reportable event of unexpected medical intervention.Impact code f2303 captures the reportable event of medication required.
Event or Problem Description
It was reported to boston scientific corporation that a piranha biopsy forceps was used during a urethroplasty for repair of membranous urethra by perineal approach procedure performed sometime in 2022.During the procedure, the acquisition of the biopsy specimen was adequate.Per operative note, there were polypoid lesions on the posterior base of the bladder.It was unclear if these lesions were secondary to the suprapubic tube or given the patient's history of a bladder cancer, that this was a new bladder cancer.Because of this, the physician elected to get biopsies of this.They placed cold cup biopsies through the flexible cystoscope and obtained multiple cold cup representative biopsies of this lesion, which was submitted to pathology.Based on pathological report, there was adequate specimen with urothelium, but low-grade urothelial carcinoma can't be excluded.The patient presented to the emergency department (ed) ten (10) days post-procedure (pod10) for bladder spasms managed with capped urethral foley and open suprapubic tube (spt) and ditropan.Per physician's assessment, the event was not serious, was possibly related to the device, and causally 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: 18929810
• Report Number: 2124215-2024-16101
• Device Sequence Number: 4579866
• 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: 75 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic