MAUDE Adverse Event Report: BIOTRONIK AG PASSEO-18 2/150/150; PERIPHERAL DILATATION CATHETER

Model Number	366129
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-18 peripheral balloon catheter was selected for treatment of a mildly calcified lesion (50% stenosis degree) in a moderately tortuous part of the distal anterior tibial artery.The system was purged and introduced via a 6 f terumo introducer to perform angioplasty of the anterior tibial artery.Upon injection of contrast, it was noted that the balloon could not be inflated.The balloon was subsequently withdrawn, and when tested outside the patient, contrast leakage was observed.
Event or Problem Description
The passeo-18 peripheral balloon catheter was selected for treatment of a mildly calcified lesion (50% stenosis degree) in a moderately tortuous part of the distal anterior tibial artery.The system was purged and introduced via a 6 f terumo introducer to perform angioplasty of the anterior tibial artery.Upon injection of contrast, it was noted that the balloon could not be inflated.The balloon was subsequently withdrawn, and when tested outside the patient, contrast leakage was observed.
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.In addition, the provided video was reviewed.In the provided video, the complaint device is visible after withdrawal from the patient.The balloon is inflated and two separate fine jets of water are visible exiting from the balloon.The technical investigation confirmed that the balloon has been inflated.And was returned in a partially deflated state.Upon inflation a fine jet of water was seen emerging from the distal end of the balloon.Microscopic inspection revealed a pinhole in the balloon surface at the distal end of the distal x-ray marker.A long scratch was observed nearby the pinhole axially prolonged into proximal direction which has 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 device 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 reported event is related to the patient's anatomy.

• Brand Name: PASSEO-18 2/150/150
• 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: 23541267
• Report Number: 8043892-2025-10312
• Device Sequence Number: 18503877
• Product Code: LIT
• UDI-Device Identifier: 07640130414716
• UDI-Public: (01)07640130414716(17)280405(10)03250520
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: 366129
• Device Lot Number: 03250520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2025
• 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