MAUDE Adverse Event Report: BIOTRONIK AG PASSEO-18 2/200/150; PERIPHERAL DILATATION CATHETER

Model Number	376296
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-18 peripheral balloon catheter was selected for treatment of a moderately calcified lesion (70% stenosis degree) in a mildly tortuous part of the distal sfa.The balloon was delivered to the lesion but could not be inflated.After withdrawal, a balloon leakage was detected.
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 one tear in the balloon surface, located directly on top of the distal x-ray marker.Scratches were observed in close vicinity of the tear which have likely been caused by a hard, sharp-edged object.The balloon has been partially inflated and was returned in a partially deflated state.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 material or manufacturing related root cause could be determined.
Event or Problem Description
The passeo-18 peripheral balloon catheter was selected for treatment of a moderately calcified lesion (70% stenosis degree) in a mildly tortuous part of the distal sfa.The balloon was delivered to the lesion but could not be inflated.After withdrawal, a balloon leakage was detected.

• Brand Name: PASSEO-18 2/200/150
• 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: tina mueller ; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• MDR Report Key: 22552868
• Report Number: 8043892-2025-06263
• Device Sequence Number: 21226726
• Product Code: LIT
• UDI-Device Identifier: 07640130430037
• UDI-Public: (01)07640130430037(17)271021(10)10240823
• 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): 08/19/2025

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: 376296
• Device Lot Number: 10240823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• 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