MAUDE Adverse Event Report: BIOTRONIK AG PASSEO-14 2.5/70/150; PERIPHERAL DILATATION CATHETER,

Model Number	380327
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-14 peripheral balloon catheter was selected for dilatation of a mildly calcified lesion in the mid anterior tibial artery (ata).Difficulties occurred while pulling out the balloon catheter from the sheath after deflation.After pulling out the device, it was detected that the stiffening wire came out from the distal shaft near the balloon.
Event or Problem Description
The passeo-14 peripheral balloon catheter was selected for dilatation of a mildly calcified lesion in the mid anterior tibial artery (ata).Difficulties occurred while pulling out the balloon catheter from the sheath after deflation.After pulling out the device, it was detected that the stiffening wire came out from the distal shaft near the balloon.
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.The technical investigation revealed that the balloon has been inflated and was returned in a partially deflated state with dried contrast medium residue in the balloon.It could be confirmed that the distal end of the stiffening wire is protruding from the distal device shaft close to a fixation weld of the two shafts.The inner shaft is severely deformed (i.E., compressed) close to the protrusion site.Scratches were observed on the inside of the outer shaft close to the protrusion site, heading towards the protrusion.In the as returned state, an inflation was possible up to 7 atm (np), but a leakage was observed when exceeding 9 atm and pressure could no longer be held, indicating that the perforation of the outer shaft wall was induced after the inflation of the complaint device to the reported 12 atm.As was reported by the physician, that resistance was met when attempting to withdraw the complaint device from the patient, it is likely that the outer shaft system was elongated elastically, the distal end of the stiffening wire passed the fixation weld and was pushed back through the wall of the outer shaft at the weld, as the tensile force was released.Tests with reference devices have shown that this mechanism is possible, however only when applying a high tensile force.The reported deflation time of 5 seconds is insufficient to fully deflate the balloon.When remaining contrast medium is trapped in the balloon and the balloon is pulled into the introducer sheath, the trapped liquid collects at the distal end of the balloon, blocking it from withdrawal, even though the used introducer sheath is compatible with the complaint device.Review of the production documentation confirmed that the device in question was manufactured according to specifications and successfully passed all in-process controls as well as the final inspection.During production, the stiffening wire distal end position is verified relative to the outer shaft weld.In addition to visual inspections each device is tested for air tightness by means of a helium leak test.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The most probable root cause for the reported event is related to the handling during the preparations for the intervention (i.E., deflation time too short, application of high tensile force).It should be noted that the ifu clearly advices the user to deflate the balloon for at least 20-45 seconds and to withdraw the dilatation catheter carefully from the lesion and out through the introducer sheath.

• Brand Name: PASSEO-14 2.5/70/150
• 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 8180 ; SZ 8180
• MDR Report Key: 23616461
• Report Number: 8043892-2025-11117
• Device Sequence Number: 10037780
• Product Code: LIT
• UDI-Device Identifier: 07640130433632
• UDI-Public: (01)07640130433632(17)280518(10)04252745
• 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: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: 380327
• Device Lot Number: 04252745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• 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
• Patient Sex: Unknown