MAUDE Adverse Event Report: BIOTRONIK AG Passeo-18 5/150/130; Peripheral Dilatation Catheter

Model Number	366134
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 sfa.The balloon inflated only proximally and failed to fully expand despite inflation to 4 atm and reinflation attempts.The balloon was removed and replaced with another balloon of the same size, which functioned normally without any issues.

• Brand Name: Passeo-18 5/150/130
• 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: tina mueller ; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• MDR Report Key: 50173434
• Report Number: 8043892-2026-07131
• Device Sequence Number: 18210337
• Product Code: LIT
• UDI-Device Identifier: 07640130414761
• UDI-Public: (01)07640130414761(17)290223(10)01267278
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K151744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: 366134
• Device Lot Number: 01267278
• 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: 07/13/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2026
• 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