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	02/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An oscar peripheral multifunctional catheter system was selected for revascularization of a stage 4 posterior tibial artery.The oscar dilator was moved to the tibial fibular trunk but were unable to be moved on the wire.When the oscar balloon was introduced in the support catheter, the white/blue handle (lock grip) totally disconnected from the catheter they then had to retrieve the whole system and continued the procedure in the traditional way with no harm to the patient.
Additional Manufacturer Narrative
29-may-2024 additional information.Two months after opening this complaint, biotronik was informed that the device was contaminated with hepatitis c and thus discarded at the hospital.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 production documentation verified that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.The tensile strength of the bond between braided shaft and lock grip is tested by means of manufacturing process output monitoring.Manufacturing process output monitoring did not reveal any violation of specifications or deviations from validated process parameters or process control cards that could be associated with the reported complaint/malfunction.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# nc-24-004.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 production documentation verified that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.The tensile strength of the bond between braided shaft and lock grip is tested by means of manufacturing process output monitoring.Manufacturing process output monitoring did not reveal any violation of specifications or deviations from validated process parameters or process control cards that could be associated with the reported complaint/malfunction.Based on the conducted investigations, no manufacturing or material related root cause could be determined.

• 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: 18890270
• Report Number: 1028232-2024-01378
• Device Sequence Number: 16916463
• Product Code: LIT
• UDI-Device Identifier: 07640130455597
• UDI-Public: (01)07640130455597(17)2606
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2024

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: 06/25/2026
• Device Model Number: 454332
• Device Catalogue Number: 454332
• Device Lot Number: 05231647
• 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: 03/07/2024
• Supplement Date Received by Manufacturer: 05/29/2024; 10/22/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 05/29/2024; 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2023
• 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