MAUDE Adverse Event Report: BIOTRONIK AG PASSEO-18 2.5/150/130; PERIPHERAL DILATATION CATHETER

Model Number	366130
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-18 peripheral balloon catheter was selected for treatment of a moderately calcified lesion with 70% stenosis degree.The device was delivered to the lesion but could not be inflated.It was noticed after withdrawal that the balloon was broken.
Event or Problem Description
The passeo-18 peripheral balloon catheter was selected for treatment of a moderately calcified lesion with 70% stenosis degree.The device was delivered to the lesion but could not be inflated.It was noticed after withdrawal that the balloon was broken.
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 balloon has been partially inflated.During functional testing, pressure could not be increased above 4 atm.Water was seen to emerge from several spots in the center of the balloon.Microscopic inspection revealed five holes in a straight line over a length of about 33 mm, starting about 38 mm proximal to the distal radiopaque marker.In close vicinity of the holes, compressions, scratches and surface abrasions were observed which have likely been caused by a hard, sharp-edged object.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.We can therefore confirm that the device was delivered in a leak-proof condition.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.

• Brand Name: PASSEO-18 2.5/150/130
• 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: 23119634
• Report Number: 8043892-2025-09012
• Device Sequence Number: 9298271
• Product Code: LIT
• UDI-Device Identifier: 07640130414723
• UDI-Public: (01)07640130414723(17)270711(10)07240233
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: 366130
• Device Lot Number: 07240233
• 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: 09/01/2025
• Supplement Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2024
• 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