MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND OSCAR PTA 3/20-180/127; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	454345
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
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.The technical investigation revealed a damage to the tip, a tear is visible at the end of the tip confirming the narrative of the physician.The balloon has not been inflated and is still well folded.Review of the production documentation confirmed that the product was manufactured according to specifications and passed all in-process and final inspections during which each product is checked for kinks and deformations.During the production, an auxiliary wire is present inside of the guidewire lumen, which is removed axially when the product is already placed inside of the blister.We can therefore confirm that the product was delivered in a kink-free condition.Based on the conducted investigations, no material or manufacturing related root cause could be determined.The root cause for the complaint event is most likely related to the guide wire used during the intervention (i.E., the guide wire cut the device tip).
Event or Problem Description
It was intended to treat a moderately calcified cto lesion in a moderately tortuous segment of the anterior tibial artery.An oscar pta balloon was introduced and successfully inflated.After inflation, the guidewire got damaged and showed a wrinkling at the distal end, following it was not possible to remove the guidewire.Both, guide wire and oscar pta balloon were removed, and a damage to the hydrophilic coating of the guide wire was confirmed.A new wire was introduced, and the balloon was positioned in the target lesion.A second inflation was not possible as the oscar pta balloon leaked (reported under 1028232-2024-00128).A second oscar pta balloon (complaint device) was introduced together with the new guide wire.During manipulation, the second guide wire got damaged as well, the hydrophilic coating got peeled off.Both, the guide wire and the second oscar pta balloon were withdrawn, and the intervention was finalized using a standard pta balloon.
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.The technical investigation revealed a damage to the tip, a tear is visible at the end of the tip confirming the narrative of the physician.The balloon has not been inflated and is still well folded.Review of the production documentation confirmed that the product was manufactured according to specifications and passed all in-process and final inspections during which each product is checked for kinks and deformations.During the production, an auxiliary wire is present inside of the guidewire lumen, which is removed axially when the product is already placed inside of the blister.We can therefore confirm that the product was delivered in a kink-free condition.Based on the conducted investigations, no material or manufacturing related root cause could be determined.The root cause for the complaint event is most likely related to the guide wire used during the intervention (i.E., the guide wire cut the device tip).

• Brand Name: OSCAR PTA 3/20-180/127
• 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: 18669194
• Report Number: 1028232-2024-00747
• Device Sequence Number: 8063812
• Product Code: LIT
• UDI-Device Identifier: 07640130455689
• UDI-Public: (01)07640130455689(17)2601
• Combination Product (Y/N): N
• Initial Reporter Country: AT
• 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
• Report Date (Section B): 12/11/2024

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: 03/12/2026
• Device Model Number: 454345
• Device Catalogue Number: 454345
• Device Lot Number: 01232812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• 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: 12/09/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2023
• 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