MAUDE Adverse Event Report: SORIN GROUP USA, INC. AORTIC ARCH CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number	RA-1127
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Excessive Tear Production (2235)
Date of Event	05/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This issue was reported in response to a field action notification that the customer received regarding the involved product.However, the customer reported during follow-up communication that the facility was unable to determine what caused the tear and that the event was never attributed to the cannula by the hospital.Additionally, the issue subject of the field action is not known to cause the reported condition, and the involved device was not saved for return so it cannot be determined if it was affected by the issue outlined in the field action.At this time, there is no known device issue and there is no reason for sorin group to believe that the device contributed to the reported event.As an investigation could not be performed, a root cause was not determined and corrective actions were not identified.
Event or Problem Description
Sorin group received a report that an aortic tear resulting in greater than 1000ml of blood loss occurred during decannulation of the aortic arch cannula.The patient survived with no other complications.The customer reported that the cause of the tear could not be determined by the surgeon.

• Brand Name: AORTIC ARCH CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 6726339
• Report Number: 1718850-2017-00011
• Device Sequence Number: 882396
• Product Code: DWF
• UDI-Device Identifier: 10803622105019
• UDI-Public: (01)10803622105019(240)RA-1127(17)181231(10)1535500087
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K943934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: RA-1127
• Device Lot Number: 1535500087
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2017
• Initial Report FDA Received Date: 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other