PANTERA LEO 3.5/12 367008 SEE MODEL NO.

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for PANTERA LEO 3.5/12 367008 SEE MODEL NO. manufactured by Biotronik Ag, Buelach, Switzerland.

Event Text Entries

[185491710] The pantera leo balloon catheter was selected to treat a severely calcified lesion in the lad. During inflation the balloon ruptured at 17 atm.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1028232-2020-01466
• MDR Report Key: 9885322
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2020-03-26
• Date of Report: 2020-03-26
• Date of Event: 2020-03-04
• Date Mfgr Received: 2020-03-26
• Device Manufacturer Date: 2019-12-12
• Date Added to Maude: 2020-03-26
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 6024 JEAN ROAD
• Manufacturer City: LAKE OSWEGO OR 97035
• Manufacturer Country: US
• Manufacturer Postal: 97035
• Manufacturer Phone: 8772459800
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PANTERA LEO 3.5/12
• Generic Name: BASIC CORONARY ANGIOPLASTY BALLOON CATHETER
• Product Code: LOX
• Date Received: 2020-03-26
• Returned To Mfg: 2020-03-23
• Model Number: 367008
• Catalog Number: SEE MODEL NO.
• Lot Number: 12191154
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BIOTRONIK AG, BUELACH, SWITZERLAND
• Manufacturer Address: ACKERSTRASSE 6 BUELACH CH-8180 CH CH-8180

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-26