MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND OSCAR; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4.0/20-180/128
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Event occurred while using oscar attempting a cto lesion in the sfa.Stopcock on side support was left open and bleed back was noticed.When aspirating and flushing, air was noticed in the system.Tuohy was checked and was tight and locking collar was in lock position.System was then removed from patient.System was flushed and while flushing, fluid was noticed coming out behind the white tip control barrel.Apparently, there is a crack or faulty piece in the system.
Additional Manufacturer Narrative
Only the oscar pta balloon was returned and subjected to a detailed technical analysis.The production documentation of the affected oscar support catheter and oscar dilator was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The oscar pta balloon was returned inside the ring protector with the protective tubing applied covering the entire balloon.The instrument shows no signs of use and is undamaged besides a mild kink at the distal end of the metal tube.The affected oscar support catheter and oscar dilator were not returned.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations, no manufacturing or material related root cause could be identified.

• Brand Name: OSCAR
• 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: 17347625
• Report Number: 1028232-2023-03575
• Device Sequence Number: 17662279
• Product Code: LIT
• UDI-Device Identifier: 07640130455771
• UDI-Public: (01)07640130455771(17)260
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K214038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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: 02/21/2026
• Device Model Number: 4.0/20-180/128
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02230295
• 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: 07/06/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• 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