MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 XEO 6/80/90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	428807
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-35 xeo peripheral dilatation catheter was selected for treatment of a mildly calcified lesion (90 percent stenosis degree) in a brachial fistula.The balloon burst circumferential and came apart as it was inflated to burst pressure in the fistula.It was able to be removed fully and there was no patient injury.
Event or Problem Description
The passeo-35 xeo peripheral dilatation catheter was selected for treatment of a mildly calcified lesion (90 percent stenosis degree) in a brachial fistula.The balloon burst circumferential and came apart as it was inflated to burst pressure in the fistula.It was able to be removed fully and there was no patient injury.
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 device was returned severely damaged and fractured in three parts.In the as-returned state, the distal device portion was located on a 0.035 inch guidewire together with an about 10 mm long balloon fragment.The guidewire is severely damaged at its distal end (i.E.Appears cut off).The distal device portion (device tip, distal balloon portion, distal inner shaft portion with distal radiopaque marker) is stuck on the returned guidewire.The device tip is severely deformed and sliced open.The inner shaft is axially compressed and has fractured about 97 mm proximal to its distal end.The inner shaft diameter does not comply anymore with the specification.The fracture site is plastically deformed which is indicative for mechanical overload.The proximal device portion (device hub, device shaft, proximal balloon portion) has a length of 984 mm.All balloon fragments have burst/torn transversally.In close vicinity to the tearing edges, scratches were observed which have likely been caused by a hard, sharp-edged object such as e.G.Anatomical structure.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 patients anatomy.The balloon and the inner shaft most likely fractured as a consequence during withdrawal due to tensile overload.It should be noted that the ifu advises the user to not exceed the rated burst pressure (rbp) indicated in the compliance chart.

• Brand Name: PASSEO-35 XEO 6/80/90
• 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: 21527398
• Report Number: 1028232-2025-01148
• Device Sequence Number: 12856746
• Product Code: LIT
• UDI-Device Identifier: 07640130451780
• UDI-Public: (01)07640130451780(17)2711
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K222065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Operator of Device: Health Professional
• Device Model Number: 428807
• Device Catalogue Number: 428807
• Device Lot Number: 10244162
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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