MAUDE Adverse Event Report: BIOTRONIK AG PASSEO-18 3/200/130; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	376298
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the complaint device nor the angiographic material was provided for analysis.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 for the product detailed above verified that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations no manufacturing related root cause could be identified.It should be noted that the ifu states that the passeo-18 peripheral dilatation catheter is indicated to dilate stenosis in the femoral, popliteal and infrapopliteal arteries.Further, the ifu states that the passeo-18 peripheral dilatation catheter is contraindicated if the lesion cannot be crossed with a guide wire.
Event or Problem Description
The passeo-18 peripheral balloon catheter was selected for treatment of a severely calcified lesion in a moderately tortuous segment of the medial subclavian artery.An access was made with a 5f introducer sheath through the right femoral artery.A first attempt was made to cross the lesion with a guide wire but was unsuccessful.The guidewire was changed to a 0.018" guide wire together with a "single bend" supporting catheter but the target lesion could not be crossed.Following, the complaint device was inserted over the 0.018" guide wire.An initial attempt to cross the target lesion in the subclavian artery failed.After "repeated maneuvers" (no further information about the maneuvers or devices used were given) it was possible to cross the lesion with the guide wire.The complaint device was then advanced in steps over the target lesion and the target lesion was "dilated slowly" until a flow was established in the distal subclavian artery.Thereafter, the complaint device was withdrawn.The subclavian artery was further dilated by different other balloon catheters.After these balloons an additional drug eluting stent was implanted in the subclavian artery and the flow was fully established.Thereafter, the radial artery and the ulnar artery were treated with balloons and the intervention was finalized.The patient was treated with anti-thrombotic medication, dapt and flu-medication.The patient went back to the ward.In the provided complaint event description, no clear malfunction of the complaint product was described.After the analysis of this event was available, it was decided to report this event precautionary.

• Brand Name: PASSEO-18 3/200/130
• 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: tina mueller ; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• MDR Report Key: 22574650
• Report Number: 8043892-2025-06173
• Device Sequence Number: 13171112
• Product Code: LIT
• UDI-Device Identifier: 07640130430051
• UDI-Public: (01)07640130430051(17)270924(10)09240061
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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: 376298
• Device Lot Number: 09240061
• 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: 06/17/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2024
• 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