MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 3.5/12; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	367008
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A pantera leo balloon catheter was chosen for treatment of a severely calcified lesion in a severely tortuous vessel.During inflation up to 14 atm the balloon ruptured.
Additional Manufacturer Narrative
The returned delivery system was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation of the returned device revealed during functional testing a fine jet of water distal to the distal x-ray marker.The microscopic analysis of the balloon surface showed a microscopic pinhole and scratches on the balloon surface nearby the damage site review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The damage of the balloon surface is most likely related to the patients anatomy.

• Brand Name: PANTERA LEO 3.5/12
• 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: 10202595
• Report Number: 1028232-2020-02623
• Device Sequence Number: 2234108
• Product Code: LOX
• UDI-Device Identifier: 07640130415669
• UDI-Public: 07640130415669
• 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): 06/25/2020

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: 01/31/2023
• Device Model Number: 367008
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02200808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1