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

Model Number	376298
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-18 peripheral balloon catheter was selected for treatment of a severely calcified lesion (85% stenosis degree) in a severely tortuous part of the mid sfa.During inflation of the device the balloon ruptured.The device was withdrawn and no part remains in body.
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 confirmed that the balloon has been inflated and is thus not well folded anymore.The balloon has burst longitudinally over a length of about 24 mm, starting about 4 mm proximal to the proximal radiopaque marker.Microscopic inspection of the balloon surface revealed scratches in close vicinity of the tear which have likely been caused by a hard, sharp-edged object such as e.G.Anatomical structure.Besides, the device shaft was found compressed at several locations over its entire length.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 (i.E.Severe calcification).
Event or Problem Description
The passeo-18 peripheral balloon catheter was selected for treatment of a severely calcified lesion (85% stenosis degree) in a severely tortuous part of the mid sfa.During inflation of the device the balloon ruptured.The device was withdrawn and no part remains in body.

• Brand Name: PASSEO-18
• 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: 23814394
• Report Number: 8043892-2025-12053
• Device Sequence Number: 13286476
• Product Code: LIT
• UDI-Device Identifier: 07640130430051
• UDI-Public: (01)07640130430051(17)280331(10)02255849
• 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): 02/11/2026

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: 376298
• Device Lot Number: 02255849
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• 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