MAUDE Adverse Event Report: BIOTRONIK AG PANTERA PRO 3.0/15; CORONARY DILATATION CATHETER

Model Number	393302
Medical Device Problem Codes	Inflation Problem (1310); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The pantera pro coronary balloon catheter was selected for treatment of the lad.It was reported that the balloon was kinked in the packaging and would not inflate.It was not possible to apply any pressure to the balloon.No contrast passed through the inflation device to the balloon.
Event or Problem Description
The pantera pro coronary balloon catheter was selected for treatment of the lad.It was reported that the balloon was kinked in the packaging and would not inflate.It was not possible to apply any pressure to the balloon.No contrast passed through the inflation device to the balloon.
Additional Manufacturer Narrative
The returned product 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 this event.The technical investigation revealed that that the device shaft is kinked about 6 mm distal to the guide wire exit port.The balloon is slightly unfolded but has not been inflated.Contrast medium residue was observed in the inflation- and balloon lumen up to the distal balloon shoulder.Functional testing was performed by successfully inflating the balloon with water up to np and rbp during which the balloon opened normally.The balloon protector with the transportation wire was not returned.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections during which each device is checked for damages such as kinks.In addition, each device is shipped with a transportation wire to protect the device shaft from kinking.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.

• Brand Name: PANTERA PRO 3.0/15
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): BIOTRONIK AG; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• Manufacturer (Section G): BIOTRONIK AG; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• Manufacturer Contact: ramona ergler ; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• MDR Report Key: 22847385
• Report Number: 8043892-2025-08111
• Device Sequence Number: 8373255
• Product Code: LOX
• UDI-Device Identifier: 07640130437067
• UDI-Public: (01)07640130437067(17)280408(10)03255541
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K160985
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: 393302
• Device Lot Number: 03255541
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2025
• 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 Sex: Unknown