MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number	A272-40N
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.A review of the dhr did not identify any deviation or non-conformity relevant to the reported issue.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
Event or Problem Description
Sorin group italia has received a report that, during the arterial cannulation, a piece of material inside the body of the cannula has come off from the connector.There is no report of any patient injury.
Additional Manufacturer Narrative
The complained cannula and the foreign material were returned to livanova for investigation.Visual inspection of the returned cannula and the foreign material showed the foreign material was a fragment of the internal lumen of the distal end of the cannula body.The distal end of the cannula in fact presented a damage that was the same shape of the fragment.The fragment appears as to be cut away by a sharp tool.Internal investigation at the manufacturing department could not identify any possible manufacturing step or manufacturing tool that could have generated the fragment.Dhr verification of the cannula showed the device was manufactured according to product specifications.Based on livanova investigation, it is unlikely the cannula was released with such a defect since the defective part would have been intercepted and scrapped by operators during final visual controls.Accordingly, verification of the livanova complaint database could not identify any other similar event in the last 12 months.Therefore, any systematic issue could be excluded and the event can be considered an isolated event not linked with any product deficiency.Livanova investigation could not identify any possible root cause of the issue.Internal investigation excluded that the issue is ascribable to any product deficiency.However, a possible rough handling by the customer could not completely ruled out.Since the reported issue is not ascribable to any device malfunction and the risk is acceptable, no corrective action will be undertaken.Livanova will maintain monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 11496406
• Report Number: 9680841-2021-00009
• Device Sequence Number: 4781791
• Product Code: DWF
• UDI-Device Identifier: 38033178004634
• UDI-Public: (01)38033178004634(17)230126(10)2001270026(11)200127(240)A272-40N
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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: No Information
• Device Expiration Date: 01/26/2023
• Device Catalogue Number: A272-40N
• Device Lot Number: 2001270026
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1