MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND OSCAR 2.5/20-180/127; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	454333
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An oscar peripheral multifunctional catheter system was selected for treatment of the posterior tibial artery.The oscar-pta balloon metal catheter has broken near the hub while pushing.No injury was reported.The patient was discharged home.
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 of the oscar pta balloon revealed that the metal shaft is mildly bent over its entire length and has fractured at the distal end of the device hub.The pta balloon shaft is strongly kinked and has torn at the fracture site, resulting in a leakage when attempting in- or deflation.Outside of the damaged zone, the device dimensions comply with the specification.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.The most probable root cause is related to the handling during the procedure (i.E.Excessive bending).Please note that the ifu advises the user to exercise care during handling to reduce the possibility of accidental breakage, bending or kinking of the device.

• Brand Name: OSCAR 2.5/20-180/127
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 21884157
• Report Number: 1028232-2025-01933
• Device Sequence Number: 3434580
• Product Code: LIT
• UDI-Device Identifier: 07640130455801
• UDI-Public: (01)07640130455801(17)2605
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K214038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 06/26/2025

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
• Device Expiration Date: 05/08/2026
• Device Model Number: 454333
• Device Catalogue Number: 454333
• Device Lot Number: 02236125
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2023
• 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