MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. STOCKERT-SHILEY AORTIC ROOT CANNULAE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	R502-26
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided the age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).Sorin group (b)(4) manufactures the stockert-shiley aortic root cannulae.The incident occurred in (b)(6).Per exemption number e2016005.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The involved device has been requested for return to sorin group (b)(4) for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not yet returned.
Event or Problem Description
Sorin group (b)(4) has received a report that at the beginning of a procedure, a plastic part of the aortic needle broke into two pieces.There is no report of any patient injury.
Additional Manufacturer Narrative
Sorin group italia manufactures the stockert-shiley aortic root cannulae.The incident occurred in sassari, italy.Per exemption number e2016005, sorin group italia s.R.L.Is submitting the report for both sorin group italia s.R.L (manufacturer) and livanova usa., inc.(importer).The involved cannula was requested for return to sorin group italia, however the device has not been provided for investigation.During follow-up communication with the customer, photographic were provided which enabled sorin group italia to verify that the larger ring was broken along its longitudinal axis.No other complaint has been received for the reported lot of cannula.Review of the sorin group italia complaint database showed that the reported failure has a very low frequency of occurrence.Based on this, and because the product was not returned for investigation, no corrective actions were identified.Sorin group italia will continue to monitor the market for similar cases.

• Brand Name: STOCKERT-SHILEY AORTIC ROOT CANNULAE
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola (mo) 41037 ; IT 41037
• MDR Report Key: 7572882
• Report Number: 9680841-2018-00014
• Device Sequence Number: 2514890
• Product Code: DWF
• UDI-Device Identifier: 08033178004022
• UDI-Public: (01)08033178004022(17)191118(10)1611180024
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K861310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2018

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: 11/18/2019
• Device Model Number: R502-26
• Device Catalogue Number: R502-26
• Device Lot Number: 1611180024
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/09/2018
• Device Age: 19 MO
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1