MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 XEO 7/40/90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	428790
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-35 xeo peripheral dilatation catheter was selected for treatment.The balloon ruptured.
Additional Manufacturer Narrative
23-apr-2025 additional event information the complaint device was introduced into the patients body and inflated (no information about the applied pressure and number of inflations was provided).During inflation, the balloon burst.Upon removal of the balloon, it was discovered that it had burst transversally.During withdrawal, the distal part of the balloon tore off inside of the patient and had to be retrieved.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 device was returned severely damaged and fractured in two parts.The distal device fragment (device tip, distal balloon portion, distal inner shaft portion) has a length of about 38 mm.The proximal device fragment (device hub, device shaft, inner shaft with both radiopaque markers, proximal balloon portion) has a length of 926 mm.The balloon has burst transversally and has separated.In close vicinity to the tearing edges, additional longitudinal bursts and severe 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 has fractured distal to the distal radiopaque marker.The inner shaft and the fracture sites are plastically deformed.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 fractured as a consequence during withdrawal due to tensile overload.

• Brand Name: PASSEO-35 XEO 7/40/90
• 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: 21687687
• Report Number: 1028232-2025-01475
• Device Sequence Number: 18355207
• Product Code: LIT
• UDI-Device Identifier: 07640130451612
• UDI-Public: (01)07640130451612(17)2711
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• 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: 428790
• Device Catalogue Number: 428790
• Device Lot Number: 10242543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2024
• 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