MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL CANNULA CARDIOPLEGIA AORTIC; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	R502-20
Medical Device Problem Codes	Crack (1135); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information were not provided.Sorin group italia manufactures the cannula cardioplegia aortic.The incident occurred in ireland.The involved device has been requested for return to sorin group italia for 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 italia has received a report that, during a procedure, the aortic root cannula had a hole in the cannula body approximately 2.5 inches from the luer port.The issue was detected at cannulation in the patients aorta and the systemic blood pressure squirted blood out of the hole.There is no report of any patient injury.
Additional Manufacturer Narrative
The dhr review highlighted that the involved lot of (b)(4) manufactured units was released as conform according to specifications.The complaints review was able to identify one similar issue on this part number but different lot from the same customer (9680841-2023-00010).No other similar events were recorded on this type of cannula, worldwide.Unit was returned to livanova facility for investigation.Visual inspection confirmed the presence of a hole on the body of the cannula.The hole appears to be caused by a sharp shape from the inside of the cannula to the outside of the cannula.The damage is compatible with a pinch from the inside of the internal metal needle included in the cannula (after initial insertion of the cannula, the needles is then removed).The damaged cannula was shown to manufacturing personal and manufacturing personal confirmed no similar issue has been observed before during manufacturing.No scrap or non conformity was opened for this type of failure before.As per livanova standard procedure, 100% of the cannula are subjected to visual inspection.It is unlikely that a similar hole would have gone undetected.In the case such a failure would have been detected during manufacturing, the unit would have been scrapped based on all the above, it cannot be excluded that the complained hole was accidentally caused by the user during the extraction of the internal metal needle form the body of the cannula.Since the root cause was not clearly assessed, all the manufacturing personal will be involved in a dedicated training meeting and the pictures of the failure will be shown to sensitize on the possible failure.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 intial report.

• Brand Name: CANNULA CARDIOPLEGIA AORTIC
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola
• Manufacturer (Section G): SORIN GROUP ITALIA; strada statale 12 nord, 86; modena 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 16711474
• Report Number: 9680841-2023-00011
• Device Sequence Number: 13878180
• Product Code: DWF
• UDI-Device Identifier: 38033178004016
• UDI-Public: (01)38033178004016(17)250731(10)2208010120(11)220801(240)R502-20
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K861310
• 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): 07/04/2023

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: 07/31/2025
• Device Model Number: R502-20
• Device Lot Number: 2208010120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown