MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 XEO 6/40/90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	428789
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-35 xeo peripheral dilatation catheter was selected for treatment of mildly calcified lesion in the fistula.The passeo-35 xeo was not even inflated at nominal pressure yet and the balloon fractured radially.
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 that the device has fractured in at least two parts.Only the proximal device portion was returned.The proximal device portion (device hub, device shaft, inner shaft with both radiopaque markers, proximal balloon portion) has a length of 962 mm.The balloon has burst transversally.In close vicinity to the tearing edge, scratches were observed which have likely been caused by a hard, sharp-edged object such as e.G.Anatomical structure.The inner shaft is plastically deformed and has fractured about 6 mm distal to the distal radiopaque marker.The inner shaft diameter does not comply anymore with the specification.Also, the distal radiopaque marker is severely damaged.Both the introducer sheath and the guidewire used in the intervention were not returned.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 fractured as a consequence during withdrawal due to tensile overload.

• Brand Name: PASSEO-35 XEO 6/40/90
• 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: 21709211
• Report Number: 1028232-2025-01513
• Device Sequence Number: 10011186
• Product Code: LIT
• UDI-Device Identifier: 07640130451605
• UDI-Public: (01)07640130451605(17)2712
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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: 428789
• Device Catalogue Number: 428789
• Device Lot Number: 11242983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown