MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 2.75/12; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	367005
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The pantera leo coronary balloon catheter was selected for treatment of a lesion with a 99 percent occlusive thrombus at proximal to mid rca.It was attempted to advance the device, but the lesion could not be crossed.The pantera leo was removed, and another device was used to complete the intervention successfully.
Additional Manufacturer Narrative
(b)(6) 2024 the lesion was pre-dilated.The final stents could cross the lesion by use of a guideplus ii extension catheter.The final angiogram showed a good result with timi 3 flow.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.In addition, the cathlab report provided was reviewed.The technical investigation revealed that the balloon is well folded and shows no signs of inflation.Microscopic inspection of entire device revealed no damage or irregularity.Review of the production documentation verified that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.Considering the information provided, the lesion could only be crossed by utilization of an extension catheter.The reported difficulty in lesion crossing is thus most likely related to the patients anatomy.
Additional Manufacturer Narrative
Corrected the initial reporter information.Reference capa# nc-24-004.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.In addition, the cathlab report provided was reviewed.The technical investigation revealed that the balloon is well folded and shows no signs of inflation.Microscopic inspection of entire device revealed no damage or irregularity.Review of the production documentation verified that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.Considering the information provided, the lesion could only be crossed by utilization of an extension catheter.The reported difficulty in lesion crossing is thus most likely related to the patients anatomy.

• Brand Name: PANTERA LEO 2.75/12
• 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: 19449731
• Report Number: 1028232-2024-02982
• Device Sequence Number: 18284592
• Product Code: LOX
• UDI-Device Identifier: 07640130415638
• UDI-Public: (01)07640130415638(17)2607
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K163660
• 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): 11/12/2024

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: 07/11/2026
• Device Model Number: 367005
• Device Catalogue Number: 367005
• Device Lot Number: 06235317
• 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: 05/31/2024
• Supplement Date Received by Manufacturer: 08/13/2024; 11/12/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 08/14/2024; 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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