MAUDE Adverse Event Report: BIOTRONIK AG PASSEO-35 XEO 7/40/90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	428790
Medical Device Problem Codes	Fracture (1260); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A passeo-35 xeo was selected for a venous recanalization procedure.The device ruptured, leaving parts of it (including the tip, a section of the catheter, and the balloon) inside the patient's vein.A second puncture was necessary to retrieve the remaining part, which extended the duration of the procedure and the patient's anesthesia.
Event or Problem Description
A passeo-35 xeo was selected for a venous recanalization procedure.The device ruptured, leaving parts of it (including the tip, a section of the catheter, and the balloon) inside the patient's vein.A second puncture was necessary to retrieve the remaining part, which extended the duration of the procedure and the patient's anesthesia.
Additional Manufacturer Narrative
The returned product 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 hospital was contacted several times for further information regarding the complaint event but unfortunately was unresponsive.The product was returned fractured into at least two parts.The proximal shaft fragment and the distal balloon fragments were returned, the distal x-ray marker was not returned.Dried contrast medium and blood residue was observed on and in the fragments.All of the fracture sites of the fragments are severely deformed (i.E., elongated and constricted), indicating application of a high tensile force.The introducer sheath used in the intervention was not returned.The balloon has burst 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.Review of the production documentation confirmed that the complaint product was manufactured according to specifications and successfully passed all in-process inspections as well as 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, no manufacturing or material related root cause could be determined.The root cause for the complaint event is most likely related to the handling during the intervention.The device fracture is most likely related to a tensile overload during withdrawal despite feeling resistance.The balloon burst is most likely related to the patient's anatomy.It should be noted that the ifu instructs the user to exercise care during handling to reduce the possibility of accidental breakage, bending or kinking of the catheter shaft.Further, the ifu instructs the user to pull out the dilatation catheter and the introducer together in case of difficulties.In addition, it should be noted that the passeo-35 xeo is indicated to dilate stenosis in the iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

• Brand Name: PASSEO-35 XEO 7/40/90
• 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: 22735208
• Report Number: 8043892-2025-07251
• Device Sequence Number: 15729377
• Product Code: LIT
• UDI-Device Identifier: 07640130451612
• UDI-Public: (01)07640130451612(17)280318(10)03250012
• 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): 11/05/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 428790
• Device Lot Number: 03250012
• 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: 07/25/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown