MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND OSCAR 6/20-180/128; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	454338
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An oscar peripheral multifunctional catheter system was selected for treatment of a moderately calcified lesion (70 percent stenosis degree) in the moderately tortuous sfa.During a crossover procedure, the oscar support catheter with the dilatator was used but couldnt cross the lesion with the dilatator.So, it was decided to change to the 6mm oscar pta balloon.It was managed to cross the stenosis and a dilatation up to 6bar was done.The pta balloon immediately ruptured.Afterwards it was not possible to pull the pta balloon out of the support catheter.It got stuck.So, the whole oscar system was removed.Nothing remained in patient, and the procedure was completed successfully with other products.
Additional Manufacturer Narrative
The returned product was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.In the as-returned state the affected oscar pta balloon catheter was located inside the oscar support catheter with about 12 mm of the oscar pta balloon catheter protruding from the distal end of the oscar support catheter.The technical investigation confirmed that the balloon could only be withdrawn through the oscar support catheter into distal direction after proper flushing.Further investigation of the oscar pta balloon catheter revealed that the balloon has burst longitudinally over a length of about 2.5 mm and shows a second small tear 5 mm proximal to the burst.Scratches were observed in close vicinity of the tear, indicating that the damage of the balloon surface was caused by a hard, sharp-edged object such as e.G., anatomical structure.The shaft of the oscar pta balloon catheter has fractured inside of the flush port of the seal and lock grip.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections 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, no manufacturing or material related root cause could be determined.The root cause for the reported event (i.E., balloon burst) is most likely related to the patients anatomy.
Additional Manufacturer Narrative
Corrected the initial reporter information.Reference capa# nc-24-004.The returned product was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.In the as-returned state the affected oscar pta balloon catheter was located inside the oscar support catheter with about 12 mm of the oscar pta balloon catheter protruding from the distal end of the oscar support catheter.The technical investigation confirmed that the balloon could only be withdrawn through the oscar support catheter into distal direction after proper flushing.Further investigation of the oscar pta balloon catheter revealed that the balloon has burst longitudinally over a length of about 2.5 mm and shows a second small tear 5 mm proximal to the burst.Scratches were observed in close vicinity of the tear, indicating that the damage of the balloon surface was caused by a hard, sharp-edged object such as e.G., anatomical structure.The shaft of the oscar pta balloon catheter has fractured inside of the flush port of the seal and lock grip.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections 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, no manufacturing or material related root cause could be determined.The root cause for the reported event (i.E., balloon burst) is most likely related to the patients anatomy.

• Brand Name: OSCAR 6/20-180/128
• 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: 18789502
• Report Number: 1028232-2024-01029
• Device Sequence Number: 8332605
• Product Code: LIT
• UDI-Device Identifier: 07640130455757
• UDI-Public: (01)07640130455757(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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• 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: 02/15/2026
• Device Model Number: 454338
• Device Catalogue Number: 454338
• Device Lot Number: 02230312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 04/05/2024; 10/22/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 04/05/2024; 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2023
• 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