MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL PUREFLEX ARTERIAL CANNULAE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	ARTERIAL CAN.20FR FLANGE WLL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 to a5: patient information was not provided.H11: livanova manufactures the pureflex arterial cannulae.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Sorin group italia has received a report that, during aortic cannulation, when the cannula was clamped, the boby of the cannula completely broken off at the clamping point.The cannula has been replaced.There is no report of any patient injury.
Additional Manufacturer Narrative
Dhr review did not identify any non-conformity or deviation related to the reported event.The probability that blood the cannulation incorrectly performed by the user is causing harm to a patient/user has been assessed as incredible.The initial complaint report stated that during aortic cannulation, the cannula body was destroyed at the clamping point while clamping, necessitating its replacement.The customer informed livanova that the cannula breakage may have resulted from unintended excessive force applied by the perfusionist using a manual clamp.No product malfunction was identified.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.

• Brand Name: PUREFLEX ARTERIAL CANNULAE
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; via statale 12 nord, 86; mirandola (mo) 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola 80309 ; IT 80309
• Manufacturer Contact: antonella donatiello ; arvada, CO 80004
• MDR Report Key: 22059382
• Report Number: 9680841-2025-900008
• Device Sequence Number: 7639382
• Product Code: DWF
• UDI-Device Identifier: 08033178016964
• UDI-Public: (01)08033178016964(17)260326(10)2303270051(11)230327(240)RA20-2BB
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K180979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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 Expiration Date: 03/26/2026
• Device Model Number: ARTERIAL CAN.20FR FLANGE WLL
• Device Lot Number: 2303270051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2023
• 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