MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND OSCAR PTA 7/20-100/72; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	454353
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An oscar peripheral multifunctional catheter system was selected for treatment of a severely calcified chronic total occlusion, the 7 mm balloon resulted in severe type b dissection over 20cm.Required overlapping stent placement.
Additional Manufacturer Narrative
The complaint instrument was not returned and could therefore not be subjected to a technical investigation.Angiographies or other imaging material could not be obtained.Therefore, no technical investigation on the subject could be performed.The corresponding product release 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 in question was manufactured according to specifications and successfully 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.It should be noted that the ifu warns against inflation above rbp.

• Brand Name: OSCAR PTA 7/20-100/72
• 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: 16087762
• Report Number: 1028232-2023-00008
• Device Sequence Number: 6686316
• Product Code: LIT
• UDI-Device Identifier: 07640130455603
• UDI-Public: (01)07640130455603(17)2302
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2023
• Device Model Number: 454353
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 04222715
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2022
• 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