MAUDE Adverse Event Report: BIOTRONIK AG PASSEO-18 6/60/90; PERIPHERAL DILATATION CATHETER

Model Number	357467
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
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 this event.The affected device was returned together with the 4f biotronik fortress (45 cm) introducer sheath used in the intervention.The complaint device was cut as reported in the shaft region the introducer sheath was found severely deformed at its distal end and waved in its whole distal segment, confirming the physicians event description.Microscopic inspection revealed that the balloon was not fully deflated which most likely caused to the reported event.An inflation and a subsequent deflation together with a functionality test could not be performed as the complaint device was already cut in half.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was identified.The most probable root cause for the reported event is related the handling during the procedure (i.E.Insufficient deflation time).Please note that the corresponding ifu advises the user to deflate the balloon for at least 90 seconds for balloons exceeding 3.5 mm to assure that all inflation medium was completely removed.
Event or Problem Description
The passeo-18 peripheral balloon catheter was selected for treatment of a mildly calcified lesion (50% stenosis degree) in a mildly tortuous part of an unknown vessel.After balloon inflation within the vessel, resistance was encountered while attempting to withdraw the passeo-18 through the fortress device.The systems were removed as a unit, and the balloon was cut at the proximal shaft to remove it from the sheath.After re-insertion of the fortress, the procedure was then continued.
Event or Problem Description
The passeo-18 peripheral balloon catheter was selected for treatment of a mildly calcified lesion (50% stenosis degree) in a mildly tortuous part of an unknown vessel.After balloon inflation within the vessel, resistance was encountered while attempting to withdraw the passeo-18 through the fortress device.The systems were removed as a unit, and the balloon was cut at the proximal shaft to remove it from the sheath.After re-insertion of the fortress, the procedure was then continued.

• Brand Name: PASSEO-18 6/60/90
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): BIOTRONIK AG; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• Manufacturer (Section G): BIOTRONIK AG; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• Manufacturer Contact: ramona ergler ; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• MDR Report Key: 22991800
• Report Number: 8043892-2025-08261
• Device Sequence Number: 8833562
• Product Code: LIT
• UDI-Device Identifier: 07640119558783
• UDI-Public: (01)07640119558783(17)271126(10)11243234
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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: 357467
• Device Lot Number: 11243234
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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