MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND OSCAR 5/20-180/128; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	454337
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An oscar peripheral multifunctional catheter system was selected for a pta with the recanalization of sfa right side.After pre-dilatation with the oscar pta balloon, a pulsar-18 t3 was placed.Afterwards, the same oscar pta balloon was used for post-dilatation but ruptured at 8 atm.
Additional Manufacturer Narrative
The returned product was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation confirmed that the balloon has been inflated.In the as-returned condition the balloon was deflated.Microscopic inspection of the balloon surface revealed no damage or irregularity.After introduction of a 0.018 inch reference guidewire, functional testing was performed by successfully inflating the balloon with 6 atm (np) and up to 14 atm (rbp).Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections during which each instrument is tested for air tightness by means of a high-pressure test.Based on the conducted investigations of the device being subject to this complaint, we can confirm that no product failure could be determined.

• Brand Name: OSCAR 5/20-180/128
• 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: 17298489
• Report Number: 1028232-2023-03463
• Device Sequence Number: 3874821
• Product Code: LIT
• UDI-Device Identifier: 07640130455764
• UDI-Public: (01)07640130455764(17)2602
• 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
• Report Date (Section B): 08/10/2023

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: 02/20/2026
• Device Model Number: 454337
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02230299
• 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: 07/10/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2023
• 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