MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND OSCAR 6/20-180/128; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	454338
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An oscar peripheral multifunctional catheter system was selected for treatment.Event occurred while using oscar attempting to cross a lesion (100 percent stenosis degree) in the sfa.A contralateral approach was used, and while advancing the oscar system the proximal shaft of dilator fractured.System was then removed from patient.
Additional Manufacturer Narrative
The returned product was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The oscar dilator was returned inside the oscar support catheter with the device tip being located about 41.1 cm proximal to its distal end.The oscar support catheter is undamaged besides two kinks in the distal portion of the braided shaft.The braided shaft of the oscar dilator is kinked at various locations, particularly at the distal end of the metal tube.The metal tube of the oscar dilator is mildly bent over its entire length.A shaft fracture, as reported, could not be confirmed.After cleaning, flushing and introduction of a 0.018 inch reference guidewire, the returned oscar dilator could be introduced and withdrawn through the returned oscar support catheter without any unusual friction.Review of the product release documentation confirmed that the instrument was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 manufacturing or material related root cause could be identified.

• Brand Name: OSCAR 6/20-180/128
• 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: 17498939
• Report Number: 1028232-2023-04030
• Device Sequence Number: 2332093
• Product Code: LIT
• UDI-Device Identifier: 07640130455757
• UDI-Public: (01)07640130455757(17)2602
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K214038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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: 02/12/2026
• Device Model Number: 454338
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02230310
• 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: 07/26/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown