MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 XEO 4/40/90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	428787
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The paasseo-35 xeo peripheral balloon catheter was selected for treatment in a mildly calcified lesion.When the balloon was inflated, it ruptured even when it was deflated, slower than the normal rate.It was reported that the patient was not injured and that the intervention was successfully completed.
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 complaint device was returned still inside of the introducer sheath used in the intervention and could only be pushed out of the introducer sheath in distal direction.The device was returned severely damaged and fractured in the balloon part with the inner lumen still connected.The distal balloon fragment has a length of about 17 mm.The proximal balloon fragment has a length of 34 mm.The balloon has burst transversally and has separated.In close vicinity to the tearing edges, scratches were observed on the balloon surface which have likely been caused by a hard, sharp-edged object such as e.G.Anatomical structure.Moreover, the inner shaft inside of the balloon has elongated and necked down to a length of 76 mm between the radiopaque markers.The inner shaft diameter does not comply anymore with the specification.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 product is tested for air tightness by means of a pressure test and a helium leak test.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The most probable root cause for the balloon burst is related to the patient¿s anatomy.The balloon and the inner shaft most likely elongated as a consequence during withdrawal due to tensile overload.

• Brand Name: PASSEO-35 XEO 4/40/90
• 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: 22140978
• Report Number: 1028232-2025-02716
• Device Sequence Number: 12797056
• Product Code: LIT
• UDI-Device Identifier: 07640130451582
• UDI-Public: (01)07640130451582(17)2711
• Combination Product (Y/N): N
• Initial Reporter Country: SG
• PMA/510(K) Number: K222065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 06/26/2025

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
• Device Model Number: 428787
• Device Catalogue Number: 428787
• Device Lot Number: 10245098
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2024
• 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