PIRANHA 505-160 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-11 for PIRANHA 505-160 * manufactured by Boston Scientific.

Event Text Entries

[3716290] Product failed to perform once placed inside of ureter. The device failed to close once specimen was obtained. Product was removed from field.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3364058
• MDR Report Key: 3364058
• Date Received: 2013-09-11
• Date of Report: 2013-09-11
• Date of Event: 2013-09-03
• Report Date: 2013-09-11
• Date Reported to FDA: 2013-09-11
• Date Reported to Mfgr: 2013-09-24
• Date Added to Maude: 2013-09-24
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PIRANHA
• Generic Name: FORCEPS, BIOPSY
• Product Code: KOA
• Date Received: 2013-09-11
• Model Number: 505-160
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BOSTON SCIENTIFIC
• Manufacturer Address: ONE BOSTON SCIENTIFIC PLACE NATICK MA 01760 US 01760

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-09-11