MAUDE Adverse Event Report: BIOTRONIK AG PASSEO-35 XEO 9/40/90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	428792
Medical Device Problem Codes	Fracture (1260); Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2026
Type of Reportable Event	Death
Event or Problem Description
During a fistulagram, an in-stent restenosis was found.The passeo-35 xeo peripheral dilatation catheter was used for the treatment but while inflating, the balloon ruptured.Multiple attempts were made to remove the balloon, but they were unsuccessful, and the balloon separated into 2 pieces, with a portion continuing to migrate further the patient.Just about 1/4 of the balloon was able to be removed.The patient was transported from the outpatient center to the hospital for further evaluation and intervention.The next day, when the hospital decided to perform another procedure to remove the remaining parts of the device, the patient passed away.
Event or Problem Description
During a fistulagram, an in-stent restenosis was found.The passeo-35 xeo peripheral dilatation catheter was used for the treatment but while inflating, the balloon ruptured.Multiple attempts were made to remove the balloon, but they were unsuccessful, and the balloon separated into 2 pieces, with a portion continuing to migrate further the patient.Just about 1/4 of the balloon was able to be removed.The patient was transported from the outpatient center to the hospital for further evaluation and intervention.The next day, when the hospital decided to perform another procedure to remove the remaining parts of the device, the patient passed away.
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 device has fractured into at least two parts.Only the proximal device portion was returned.The length of the proximal device portion is 86.3 cm.The fractured proximal balloon portion has a length of about 23 mm.The balloon has burst and ruptured transversally.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.The inner shaft has fractured at the proximal balloon weld.The damage pattern indicates application of a high tensile force which was most likely applied after the balloon had burst (i.E.During device withdrawal).The introducer sheath used in the intervention was not returned.Review of the production documentation confirmed that the device was manufactured according to specifications and successfully passed all in-process controls and the final inspection.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 manufacturing or material related root cause could be determined.The most probable root cause for the balloon failure is related to the patient's anatomy.The device most likely fractured due to tensile overload during withdrawal.It should be noted that the ifu advises the user to exercise care during handling to reduce the possibility of accidental breakage, bending or kinking of the catheter shaft.According to the ifu, the user is further advised to remove the device and the introducer sheath together in case of difficulties during withdrawal.

• Brand Name: PASSEO-35 XEO 9/40/90
• 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: 24893426
• Report Number: 8043892-2026-03254
• Device Sequence Number: 15728382
• Product Code: LIT
• UDI-Device Identifier: 07640130451636
• UDI-Public: (01)07640130451636(17)281119(10)11250393
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 428792
• Device Lot Number: 11250393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2025
• 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
• Outcome Attributed to Adverse Event: Death; Required Intervention; Hospitalization
• Patient Sex: Unknown