MAUDE Adverse Event Report: BIOTRONIK AG PASSEO-14 4/40/150; PERIPHERAL DILATATION CATHETER

Model Number	380324
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-14 balloon catheter was chosen for treatment.The device was advanced into the target lesion and was inflated as usual but the balloon would not hold pressure.
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 this event.During the technical investigation the reported complaint event could be reproduced.Already upon flushing the guidewire lumen, water leaked from the inflation port at the device hub.During balloon inflation the pressure did not hold and water leaked from the guidewire port at the device hub.The leakage could be identified at the distal weld inside the device hub and was most likely induced during the welding process.The root cause for the reported event is therefore most likely related to the manufacturing process.The relevant internal departments were informed about the investigation results.It should be noted that passeo- 14 is indicated for balloon dilatation of the stenotic portion of a lower limb artery for the purpose of improving perfusion.
Event or Problem Description
The passeo-14 balloon catheter was chosen for treatment.The device was advanced into the target lesion and was inflated as usual but the balloon would not hold pressure.
Additional Manufacturer Narrative
Please note that the initial report was submitted by biotronik, inc.((b)(4)).The final report was submitted by biotronik ag ((b)(4)).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 this event.During the technical investigation the reported complaint event could be reproduced.Already upon flushing the guidewire lumen, water leaked from the inflation port at the device hub.During balloon inflation the pressure did not hold and water leaked from the guidewire port at the device hub.The leakage could be identified at the distal weld inside the device hub and was most likely induced during the welding process.The root cause for the reported event is therefore most likely related to the manufacturing process.The relevant internal departments were informed about the investigation results.It should be noted that passeo- 14 is indicated for balloon dilatation of the stenotic portion of a lower limb artery for the purpose of improving perfusion.Additional information: the most probable root cause was identified as a leak at the distal weld inside the hub of the affected devices.Excessive heat exposure during the distal soft welding process was determined to favor the formation of leaks, indicating a link to the manufacturing process.As a part of the corrective action, process parameters for distal soft welding were optimized by reducing maximum welding power.In addition , the pressure testing procedure was refined to ensure consistent detection of potential deviations by adapting the positioning of the wire during testing.The risk assessment of the corrective action confirmed that, considering the event rate and the potential harm to patients, the associated risk is negligible.The final effectiveness test demonstrated that the corrective action was successful.Since its implementation, no further complaints with the same root cause have been reported.

• Brand Name: PASSEO-14 4/40/150
• 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: 20782726
• Report Number: 1028232-2024-06117
• Device Sequence Number: 9053060
• Product Code: LIT
• UDI-Device Identifier: 07640130433601
• UDI-Public: (01)07640130433601(17)250228(10)02221376
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K152240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2025

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 Expiration Date: 02/28/2024
• Device Model Number: 380324
• Device Catalogue Number: 380324
• Device Lot Number: 380324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 12/20/2024; Not provided
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/23/2024; 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2022
• 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: Hospitalization
• Patient Age: 89 YR
• Patient Sex: Female