MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND OSCAR 5/20-180/128; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	454337
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An oscar peripheral multifunctional catheter system was selected for treatment of a total occlusion.The lesion could not be crossed with the device.
Additional Manufacturer Narrative
Neither the affected device nor the angiographic material was returned.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the product release documentation confirmed that the device was manufactured according to specifications and passed all in-process controls as well as the final inspection.Based on the conducted investigations, no manufacturing or material related root cause could be determined.
Additional Manufacturer Narrative
Corrected the initial reporter information.Reference capa# (b)(4).Neither the affected device nor the angiographic material was returned.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the product release documentation confirmed that the device was manufactured according to specifications and passed all in-process controls as well as the final inspection.Based on the conducted investigations, no manufacturing or material related root cause could be determined.

• Brand Name: OSCAR 5/20-180/128
• 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: 19705994
• Report Number: 1028232-2024-03667
• Device Sequence Number: 7751640
• Product Code: LIT
• UDI-Device Identifier: 07640130455764
• UDI-Public: (01)07640130455764(17)2607
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K214038
• 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): 11/20/2024

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: 07/17/2026
• Device Model Number: 454337
• Device Catalogue Number: 454337
• Device Lot Number: 04230264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2024
• Supplement Date Received by Manufacturer: 09/10/2024; 11/20/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 09/10/2024; 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2023
• 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