MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 3.0/15; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	367017
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Ous mdr - the pantera leo balloon catheter was selected for post-dilatation.During inflation up to 18 atm and 22 atm a leakage was noticed.
Additional Manufacturer Narrative
The returned instrument was subjected to a 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 leaking from the guidewire exit port.Microscopic analysis revealed a damage of the inflation lumen distal to the guidewire exit port with a shape of a longitudinal sharp cut from inside of the guidewire lumen over a length of 1 mm.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 guidewire lumen was most likely caused by a sharp object.

• Brand Name: PANTERA LEO 3.0/15
• 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: 8540411
• Report Number: 1028232-2019-01543
• Device Sequence Number: 14064379
• Product Code: LOX
• UDI-Device Identifier: 07640130415751
• UDI-Public: 07640130415751
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2019

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: 11/30/2021
• Device Model Number: 367017
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11186336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 05/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1