MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA PRO 2.0/15; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	393300
Medical Device Problem Codes	Inflation Problem (1310); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the affected device nor the angiographic material was returned.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each device is tested for air tightness by means of a helium leak test.All tested products of the lot successfully passed this test.We can therefore confirm that the device was delivered in a leak-proof condition.Based on the conducted investigations, no material or manufacturing related root cause could be determined.
Event or Problem Description
The pantera pro coronary balloon catheter was selected for treatment of a moderately calcified lesion (95 percent stenosis degree) in a mildly tortuous segment of the proximal lcx.The affected device was introduced into the patients body, but once positioned inside the target lesion the balloon could not be inflated.The affected device was withdrawn and was scrapped at the hospital.
Additional Manufacturer Narrative
The returned product 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 this event.The technical investigation revealed that the device tip is severely deformed (i.E., elongated and constricted) near the tip weld.The balloon is well folded and shows no signs of inflation.The transportation wire and the protector were not returned.As initially a balloon inflation issue was reported, functional testing was performed.The balloon opened normally.Pressure could be applied to rbp with no leakage and no pressure loss.Deflation was uneventful.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.Every device is shipped with a 0.015 inch transportation wire that covers the full guidewire lumen.No difficulties in removing the transportation wire have been reported.The device was in accordance with the specifications at the time of delivery.Based on the conducted investigations, no manufacturing or material related root cause could be determined.

• Brand Name: PANTERA PRO 2.0/15
• Common Device Name: BASIC CORONARY ANGIOPLASTY BALLOON CATHETER
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 21044962
• Report Number: 1028232-2024-06632
• Device Sequence Number: 3417803
• Product Code: LOX
• UDI-Device Identifier: 07640130437043
• UDI-Public: (01)07640130437043(17)2705
• Combination Product (Y/N): N
• PMA/510(K) Number: K160985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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: 393300
• Device Catalogue Number: 393300
• Device Lot Number: 04242476
• 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: 12/27/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• 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 Sex: Unknown