MAUDE Adverse Event Report: BIOTRONIK AG OSCAR 3/20-180/127; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	454334
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An oscar peripheral multifunctional catheter system was selected for treatment of the posterior tibial artery.By pushing against a calcified stenosis (btk), the outer catheter broke at the hub-connection.No injury was reported.
Event or Problem Description
An oscar peripheral multifunctional catheter system was selected for treatment of the posterior tibial artery.By pushing against a calcified stenosis (btk),the outer catheter broke at the hub-connection.No injury was reported.
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 support catheter revealed that the braided shaft has fractured about 2-3 mm distal to the lock grip.The fracture sites of the braided shaft are plastically deformed which is indicative for an overload fracture.Scratches were observed on the inner surface of the braided shaft and may have been induced by the metal pushrod of the oscar dilator while pushing it through a bend/curve.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, no material or manufacturing related root cause was identified.The root cause for the reported event is most likely related to the handling during the procedure, i.E., forceful pushing despite meeting resistance which is warned against in the ifu.

• Brand Name: OSCAR 3/20-180/127
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BIOTRONIK AG; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• Manufacturer (Section G): BIOTRONIK AG; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• Manufacturer Contact: ramona ergler ; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• MDR Report Key: 24363664
• Report Number: 8043892-2026-02052
• Device Sequence Number: 15868223
• Product Code: LIT
• UDI-Device Identifier: 07640130455795
• UDI-Public: (01)07640130455795(17)260910(10)06230538
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 04/15/2026

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: 09/10/2026
• Device Model Number: 454334
• Device Lot Number: 06230538
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown