MAUDE Adverse Event Report: BIOTRONIK AG PASSEO-14 2/70/150; PERIPHERAL DILATATION CATHETER

Model Number	380326
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-14 peripheral balloon catheter was selected for dilatation of a mid to distal ata stenosis.The passeo-14 was positioned at the mid ata and ready to be inflated.It was noticed that the balloon was not able to be inflated as the pressure was not able to be build up when turning the inflation device.The balloon was then fully removed and replaced with another passeo-14 to continue the procedure.
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 same was observed, i.E.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.In addition, a pinhole was detected at the distal balloon portion.In close vicinity to the pinhole scratches were observed which have likely been caused by a hard, sharp-edged object such as e.G.Anatomical structure, indicating that the pinhole was potentially caused during balloon inflation.The root cause for the reported event (i.E.Inflation issues) is most likely related to the manufacturing process.The relevant internal departments were informed about the investigation results.
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 same was observed, i.E.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.In addition, a pinhole was detected at the distal balloon portion.In close vicinity to the pinhole scratches were observed which have likely been caused by a hard, sharp-edged object such as e.G.Anatomical structure, indicating that the pinhole was potentially caused during balloon inflation.The root cause for the reported event (i.E.Inflation issues) is most likely related to the manufacturing process.The relevant internal departments were informed about the investigation results.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.
Event or Problem Description
The passeo-14 peripheral balloon catheter was selected for dilatation of a mid to distal ata stenosis.The passeo-14 was positioned at the mid ata and ready to be inflated.It was noticed that the balloon was not able to be inflated as the pressure was not able to be build up when turning the inflation device.The balloon was then fully removed and replaced with another passeo-14 to continue the procedure.

• Brand Name: PASSEO-14 2/70/150
• 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: 20010612
• Report Number: 1028232-2024-04350
• Device Sequence Number: 15244782
• Product Code: LIT
• UDI-Device Identifier: 07640130433625
• UDI-Public: (01)07640130433625(17)261010(10)09230332
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Other,Foreign,Health Professional,User Facility
• 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 Model Number: 380326
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09230332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 09/10/2024; 07/26/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/10/2024; 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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