MAUDE Adverse Event Report: CREAGH MEDICAL BIOTRONIK PASSEO-35 HP; Catheter, angioplasty, peripheral, transluminal

Model Number	399088
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The high-pressure balloon was used in a percutaneous transluminal angioplasty (pta) procedure for treatment of a moderately calcified lesion (stenosis degree: 70%) in a moderately tortuous bid-brachial artery.The target vessel also had a calcification degree of approximately 70%.Balloon inflation was attempted after placing into the target lesion.The balloon burst at the pressure of 21 atm (rated burst pressure was 23 atm).The balloon was prepped per ifu.There was no indication of any damage during device preparation.Negative pressure was confirmed to be held during loading and advancing to the target lesion and there was no loss of negative pressure.The device was not torqued or twisted during loading.The lesion length was noted to be approximately 30mm with a vessel diameter of 7mm.There was no patient injury.No parts of the balloon remained in the patient.The reported issue resulted in a procedure delay of approximately five minutes.No additional medical intervention was required.

• Brand Name: BIOTRONIK PASSEO-35 HP
• Common Device Name: Catheter, angioplasty, peripheral, transluminal
• Manufacturer (Section D): CREAGH MEDICAL; ida business park; creagh road; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL; ida business park; creagh road; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: phil haney ; 7905 golden triangle drive; suite 190; eden prairie, MN 55344 ; 9525007598
• MDR Report Key: 22721174
• Report Number: 3005994106-2025-00009
• Device Sequence Number: 9627628
• Product Code: LIT
• UDI-Device Identifier: 05391525781525
• UDI-Public: 05391525781525
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K113468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2025

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
• Device Model Number: 399088
• Device Lot Number: 22500033
• 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: 07/29/2025
• Initial Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2025
• 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 Age: 68 YR
• Patient Sex: Male