MAUDE Adverse Event Report: BIOTRONIK AG PASSEO-18 3/120/130; PERIPHERAL DILATATION CATHETER

Model Number	357508
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the passage of the passeo-18 peripheral dilation catheter, the balloon was introduced into a pre-dilated mildly calcified lesion in the posterior tibial artery.However, at a pressure of 10 atm, the balloon ruptured.The device was withdrawn, no part remained in patient.
Additional Manufacturer Narrative
Please note that the initial report was submitted by biotronik, inc.(cfn/fei 1028232).The final report was submitted by biotronik ag (cfn 8043892, fei 3002808050).Neither the affected device nor the angiographic material was returned.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.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
During the passage of the passeo-18 peripheral dilation catheter, the balloon was introduced into a pre-dilated mildly calcified lesion in the posterior tibial artery.However, at a pressure of 10 atm, the balloon ruptured.The device was withdrawn; no part remained in patient.

• Brand Name: PASSEO-18 3/120/130
• 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, OR 8180 ; SZ 8180 ; 8772459800
• MDR Report Key: 21836997
• Report Number: 1028232-2025-01784
• Device Sequence Number: 8699226
• Product Code: LIT
• UDI-Device Identifier: 07640119559193
• UDI-Public: (01)07640119559193(17)271022(10)10243164
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K072765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: 357508
• Device Catalogue Number: 357508
• Device Lot Number: 10243164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/14/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• 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