MAUDE Adverse Event Report: BIOTRONIK AG PASSEO-35 XEO 8/40/90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	428791
Medical Device Problem Codes	Fracture (1260); Material Rupture (1546)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A passeo-35 xeo was selected for treatment of the left common iliac artery.The balloon ruptured during deflation to remove the balloon from guidewire.The first part of the balloon was extracted through the guidewire, but the other part remained in the patient.This required an extensive surgical approach to extract the missing part and the use of a surgical patch.
Event or Problem Description
A passeo-35 xeo was selected for treatment of the left common iliac artery.The balloon ruptured during deflation to remove the balloon from guidewire.The first part of the balloon was extracted through the guidewire, but the other part remained in the patient.This required an extensive surgical approach to extract the missing part and the use of a surgical patch.
Additional Manufacturer Narrative
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 manufacturing or material related root cause could be determined.

• Brand Name: PASSEO-35 XEO 8/40/90
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 23189248
• Report Number: 8043892-2025-09221
• Device Sequence Number: 9843948
• Product Code: LIT
• UDI-Device Identifier: 07640130451629
• UDI-Public: (01)07640130451629(17)280219(10)01254493
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K222065
• 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): 12/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 428791
• Device Lot Number: 01254493
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 10/01/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2025
• 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