MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 2.5/15; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	367015
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A pantera leo was selected for treatment of a severely calcified lesion (90% stenosis degree) in a tortuous rca.During second inflation at 14 atm the balloon ruptured after 10 seconds.
Additional Manufacturer Narrative
The technical investigation of the returned pantera leo revealed a longitudinal burst from the distal balloon shoulder to the middle of the balloon.Further microscopic analysis showed several scratches close to the fracture site.The review of the production documentation of the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.In addition to visual inspections, each instrument is tested for airtightness by means of a helium leak test.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.Due to the scratch marks in close vicinity to the fractured site it is assumed that the balloon burst was most likely induced by the severely calcified lesion.

• Brand Name: PANTERA LEO 2.5/15
• Common Device Name: BASIC CORONARY ANGIOPLASTY BALLOON CATHETER
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 8707874
• Report Number: 1028232-2019-02393
• Device Sequence Number: 16605632
• Product Code: LOX
• UDI-Device Identifier: 07640130415737
• UDI-Public: 07640130415737
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K163660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 367015
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01190172
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1