MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 4.0/12; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	367010
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The pantera leo coronary balloon catheter was inserted to post-dilate a stent in a moderately tortuous part of the proximal cx.When inflated up to 18 bar no contrast was visible in the balloon.It was not possible to post-dilate optimally without visual confirmation.Another nc balloon was used for post-dilatation of the implanted stent.
Event or Problem Description
The pantera leo coronary balloon catheter was inserted to post-dilate a stent in a moderately tortuous part of the proximal cx.When inflated up to 18 bar no contrast was visible in the balloon.It was not possible to post-dilate optimally without visual confirmation.Another nc balloon was used for post-dilatation of the implanted stent.
Additional Manufacturer Narrative
The returned product 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 this event.The inflation equipment (i.E., inflation device, 3-waystopcock) used in the intervention was not returned.The technical investigation confirmed that the balloon has been inflated, water and/or contrast medium was observed in the balloon and in the inflation lumen and was returned in a partially deflated state.No damages to the device were observed.Functional testing was performed by connecting a reference inflation device and successfully inflating the device with 14 atm (np) and 20 atm (rbp) during which the balloon opened normally.The measured diameter of the inflated balloon at np and rbp is within specification.The reported event could not be reproduced.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be identified.

• Brand Name: PANTERA LEO 4.0/12
• Common Device Name: BASIC CORONARY ANGIOPLASTY BALLOON CATHETER
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 21434704
• Report Number: 1028232-2025-00934
• Device Sequence Number: 4605167
• Product Code: LOX
• UDI-Device Identifier: 07640130415683
• UDI-Public: (01)07640130415683(17)2712
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K163660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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 Model Number: 367010
• Device Catalogue Number: 367010
• Device Lot Number: 11241746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Male