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	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
After a pre-dilatation of the mid lad and diagonal 2 and successful stent placement in the mid lad, a 2.0/15 pantera pro coronary balloon catheter (complaint device) was selected for a post-dilation in the diagonal 2, but the lesion could not be crossed.Therefore, another 1.5/10 pantera pro was tried.Again, the lesion could not be crossed with the device (reported separately).
Additional Manufacturer Narrative
06-may-2024 additional information: a mildly calcified lesion was treated (99 percent stenosis degree at mlad and restenosis with 60 percent stenosis degree at dg2) in a severely tortuous part of the mid lad/dg2.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 the balloon is well folded and shows no signs of inflation.The crossing profile of the balloon complies with the specification.The device shows no damage or irregularity besides a mild kink in the device shaft about 10 mm proximal to the guide wire exit port.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 determined.
Additional Manufacturer Narrative
Corrected the initial reporter information.Reference capa# nc-24-004.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 the balloon is well folded and shows no signs of inflation.The crossing profile of the balloon complies with the specification.The device shows no damage or irregularity besides a mild kink in the device shaft about 10 mm proximal to the guide wire exit port.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 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: 18946531
• Report Number: 1028232-2024-01565
• Device Sequence Number: 20809971
• Product Code: LOX
• UDI-Device Identifier: 07640130437043
• UDI-Public: (01)07640130437043(17)2602
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2024

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: 02/19/2026
• Device Model Number: 393300
• Device Catalogue Number: 393300
• Device Lot Number: 02232636
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 05/06/2024; 10/23/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 05/07/2024; 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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