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

Catalog Number RA-1127

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Excessive Tear Production (2235)

Event Date 05/30/2017

Event Type  Injury  

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 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
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): SORIN GROUP USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: joan ceasar ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6726339
• MDR Text Key: 80492449
• Report Number: 1718850-2017-00011
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 10803622105019
• UDI-Public: (01)10803622105019(240)RA-1127(17)181231(10)1535500087
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: RA-1127
• Device Lot Number: 1535500087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other