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

Model Number	454332
Medical Device Problem Codes	Fracture (1260); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The oscar balloon shaft broke right after the metallic hupotube while trying to cross a severely calcified lesion at the distal pta.Extreme force was used in the attempt to cross the lesion.
Additional Manufacturer Narrative
Additional event description: the shaft of the oscar pta balloon broke just distal to the metal shaft during the attempt to cross the lesion.All fragments were successfully withdrawn.Investigation results: the affected device was returned together with a device which has been used in a patient with an infectious disease.It was decided to perform no technical investigation and to discard the device at the manufacturers facilities.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 production 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 material or manufacturing related root cause could be determined.Considering the event description, the most probable root cause for the complaint event is related to the handling during the procedure (i.E.Application of high force).Please note that the ifu advises the user to exercise care during handling to reduce the possibility of accidental breakage, bending or kinking of the device.
Additional Manufacturer Narrative
Corrected the initial reporter information.Reference capa# nc-24-004.Additional event describtion: the shaft of the oscar pta balloon broke just distal to the metal shaft during the attempt to cross the lesion.All fragments were successfully withdrawn.Investigation results: the affected device was returned together with a device which has been used in a patient with an infectious disease.It was decided to perform no technical investigation and to discard the device at the manufacturers facilities.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 production 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 material or manufacturing related root cause could be determined.Considering the event description, the most probable root cause for the complaint event is related to the handling during the procedure (i.E.Application of high force).Please note that the ifu advises the user to exercise care during handling to reduce the possibility of accidental breakage, bending or kinking of the device.

• 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: 18669183
• Report Number: 1028232-2024-00745
• Device Sequence Number: 20848962
• Product Code: LIT
• UDI-Device Identifier: 07640130455597
• UDI-Public: (01)07640130455597(17)2605
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 10/17/2024

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: 05/03/2026
• Device Model Number: 454332
• Device Catalogue Number: 454332
• Device Lot Number: 02236106
• 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: 02/07/2024
• Supplement Date Received by Manufacturer: 04/09/2024; 10/17/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 04/09/2024; 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2023
• 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