MAUDE Adverse Event Report: CREAGH MEDICAL BIOTRONIK PASSEO-35 HP; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	399096
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: to date, the device had not been returned.If returned, a supplemental mdr will be submitted for analysis results.
Event or Problem Description
The balloon catheter was used for a treatment of a lesion with 70% stenosis in the mild left brachiocephalic fistula (bcf).The balloon was prepared as per ifu.The balloon was inflated at 18 atm and operated as expected during the first inflation.A second inflation at 18 atm was performed and the balloon burst before the rated burst pressure was reached.There was no calcification and not tortuous anatomy.There was no patient injury.
Additional Manufacturer Narrative
H3: analysis confirmed a longitudinal bust.The burst travelled the length of the balloon and terminated at the proximal and distal cones.

• 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 ; 9525077598
• MDR Report Key: 18926895
• Report Number: 3005994106-2024-00002
• Device Sequence Number: 11897362
• Product Code: LIT
• UDI-Device Identifier: 05391525781600
• UDI-Public: 05391525781600
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K113468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2024

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: 10/01/2026
• Device Model Number: 399096
• Device Lot Number: 22301637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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: Male