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

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2018

Event Type  malfunction  

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).(b)(4).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 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.

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
• Type of Device: 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
• MDR Text Key: 110588921
• Report Number: 9680841-2018-00014
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 08033178004022
• UDI-Public: (01)08033178004022(17)191118(10)1611180024
• Combination Product (y/n): N
• PMA/PMN Number: K861310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 07/24/2018
• Supplement Dates FDA Received: 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1