MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND OSCAR 2/20-180/127; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	454332
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
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 posterior tibial artery.A contralateral approach was used, and while advancing the oscar system the proximal shaft fractured.System was then removed from patient.
Additional Manufacturer Narrative
The returned product was subjected to a detailed technical analysis and the corresponding product review documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.In addition, two images and one video were provided.The technical investigation of the oscar support catheter revealed that the braided shaft has been torn 5 cm distal to the kink protector.In addition, the shaft of the oscar dilator was found kinked at the distal end of the metal tube.The findings indicate the presence of a curve or an angle at the access site and it appears that due to this, forces were applied to the oscar support catheter braided shaft that eventually led to the tear.The two images show the damage of the oscar support catheter shaft.The video confirms the position of the damage approximately 5 cm distal to the kink protector.Review of the product release documentation verified that the instrument 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 2/20-180/127
• 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: 17498944
• Report Number: 1028232-2023-04031
• Device Sequence Number: 2332096
• Product Code: LIT
• UDI-Device Identifier: 07640130455597
• UDI-Public: (01)07640130455597(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: User Facility,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: 02/27/2026
• Device Model Number: 454332
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02232427
• 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: 07/25/2023
• 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: 03/01/2023
• 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