MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA PRO 2.0/10; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	393293
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
After pre-dilatation of the lesion with a pantera balloon 3.0/15, an unknown stent was inserted in the mid lad.Subsequently, the complaint pantera pro was attempted to be used for pre-dilatation in a side branch of the lad, but the balloon did not pass.A 2nd attempt was made but the balloon still did not cross the side branch.It was decided to stop the procedure, continue to give medicine to patient, and made appointment for a follow up.
Additional Manufacturer Narrative
03-may-2024 after additional correspondence with the local staff, it was clarified that that the physician thought that no matter what size it was, it would probably be difficult to pass which caused the physician to decide to stop procedure and continuously give medicine to the patient.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.In addition, six images taken from the angiogram were reviewed.The technical investigation revealed that the balloon is well folded and shows signs of inflation.The crossing profile of the balloon complies with the specification.The device shows no damage or irregularity.Review of the images taken from the angiogram did not provide any further relevant information with regards to the root cause of the complaint.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.In addition, six images taken from the angiogram were reviewed.The technical investigation revealed that the balloon is well folded and shows signs of inflation.The crossing profile of the balloon complies with the specification.The device shows no damage or irregularity.Review of the images taken from the angiogram did not provide any further relevant information with regards to the root cause of the complaint.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 2.0/10
• 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: 18946544
• Report Number: 1028232-2024-01576
• Device Sequence Number: 20873206
• Product Code: LOX
• UDI-Device Identifier: 07640130436978
• UDI-Public: (01)07640130436978(17)2511
• 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: 11/22/2025
• Device Model Number: 393293
• Device Catalogue Number: 393293
• Device Lot Number: 11221967
• 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: 05/03/2024; 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: 11/24/2022
• 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