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

Model Number	357508
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-18 peripheral balloon catheter was selected for treatment of the proximal anterior tibial artery.The device was introduced for an angioplasty procedure, but it burst before reaching nominal pressure.The burst balloon was removed and replaced by a balloon from another company, which was successfully inflated.
Event or Problem Description
The passeo-18 peripheral balloon catheter was selected for treatment of the proximal anterior tibial artery.The device was introduced for an angioplasty procedure, but it burst before reaching nominal pressure.The burst balloon was removed and replaced by a balloon from another company, which was successfully inflated.
Additional Manufacturer Narrative
The returned device was subjected to a 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 a fine jet of water emerging from the proximal part of the balloon when attempting inflation.Microscopic analysis of the balloon surface showed a small pinhole about 36 mm distal to the proximal x-ray marker.In close vicinity to the pinhole deep 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 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, no manufacturing or material related root cause could be determined.The root cause is most likely related to the patient's anatomy.

• 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: 24209608
• Report Number: 8043892-2026-01125
• Device Sequence Number: 9635728
• Product Code: LIT
• UDI-Device Identifier: 07640119559193
• UDI-Public: (01)07640119559193(17)280223(10)02251246
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 01/29/2026

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: 357508
• Device Lot Number: 02251246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• 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