MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PIRANHA; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number M0065051600

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematuria (2558); Swelling/ Edema (4577)

Event Date 01/10/2020

Event Type  Injury  

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2020, was chosen as the best estimate based on the procedure which happened sometime in 2020 and nine (9) days post-procedure (pod09) ed presentation for hematuria and lle.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 e2338 captures the reportable event of lower limb edema.Patient code e1302 captures the reportable event of hematuria.Impact code f12 captures the reportable event of serious injury.

Event 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 2020.During the procedure, the acquisition of the biopsy specimen was adequate.Nine (9) days post-procedure (pod09) the patient presented to the emergency department (ed) for hematuria and lower limb edema (lle).Computed tomography arterial portography (ctap) found no evidence of pelvic thrombus and with evidence of prostate cancer with metastatic lymphadenopathy.Lle doppler revealed no evidence of deep vein thrombosis (dvt).The patient was discharged from the ed without admission.Per physician's assessment, the event was not serious, was possibly related to the device, and probably related to the procedure.

• Brand Name: PIRANHA
• Type of Device: 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: 18926169
• MDR Text Key: 337926496
• Report Number: 2124215-2024-15327
• Device Sequence Number: 1
• Product Code: FCL
• UDI-Device Identifier: 08714729302599
• UDI-Public: 08714729302599
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0065051600
• Device Catalogue Number: 505-160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Race: White