MAUDE Adverse Event Report: SORIN GROUP ITALY PEDIATRIC ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPLUMONARY BYPASS

Catalog Number	A272-30N
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: sorin group italy manufactures the pediatric arterial cannula.The incident occurred in (b)(6), united kingdom.(b)(4) initiated an investigation.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 italy received a report related to an arterial pediatric cannula that split vertically and peeled off the connector on the arterial line when the surgery was just finished.Medical team elected to cut it horizontally and reattached to the arterial line.There was no patient injury.
Additional Manufacturer Narrative
A picture was provided showing cannula tail split.Cannula was requested for further investigations: during visual inspection the cut, 3 cm long, was confirmed from cannula bottom tail to 1/4'' printed mark.The marking phase is performed through the insertion of a specific mandrel in the proximal tube of the cannula necessary for the printing.Considering that the mandrel has a shaped steel component internally, it cannot be ruled out that inserting it with excessive force or in the wrong direction accidentally can lead to the reported condition.Based on the above facts and considering the extent of the fracture, it cannot be ruled out that if the the crack initiated at the time of assembly in livanova plant was tiny and acceptable and that further grew and propagated under the application of mechanical and thermal stresses during shipping/transportation and use.Analysis of complaints database revealed it is an isolated case and no other similar cases notified for batch concerned nor for this product part number, neither concerning trend has been identified.The manufacturing personel will be involved in a dedicated training meeting awaring of customer complaint.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: PEDIATRIC ARTERIAL CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPLUMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALY; via statale 12 nord, 86; mirandola
• Manufacturer (Section G): LIVANOVA USA INC; 14401 w. 65th way; arvada CO 80004
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20893191
• Report Number: 9680841-2024-00033
• Device Sequence Number: 8933955
• Product Code: DWF
• UDI-Device Identifier: 08033178004619
• UDI-Public: (01)08033178004619(17)261019(10)2310200010(240)A272-30N
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K023622
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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 Catalogue Number: A272-30N
• Device Lot Number: 2310200010
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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