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

Catalog Number RA-2117

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2014

Event Type  Other  

Event Description

Sorin group received a report that the aortic arch cannula dislodged from the patient's aorta during bypass.There was no report of patient injury.

Manufacturer Narrative

The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

Sorin group received a report that the aortic arch cannula dislodged from the patient's aorta during bypass.It was also reported that the issue may have been related to the condition of the patient's aorta.There was no report of patient injury.The involved product was not saved for evaluation, so no product was returned.Communication with the procedural specialist indicated there was no report that the issue was caused by a defect in this unit but that the surgeon felt the tip of the cannula was too short by design.A review of complaint data found that, since 2010 there have been (b)(4) cannula released which were built with the same tip component and there have been no other complaints for the tip popping out of the aorta.Based on the information summarized above, sorin group has concluded that there is not a problem with the cannula.No lot number was reported and so a specific device history record could not be identified for review.No trend for this type of issue has been identified.The market will be monitored for trends related to this issue.Device not saved by customer.

• Brand Name: AORTIC ARCH CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 west 65th way; arvada CO 80004
• Manufacturer (Section G): SORIN GROUP USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: carrie wood ; 14401 w 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 4170597
• MDR Text Key: 4872182
• Report Number: 1718850-2014-00346
• Device Sequence Number: 1
• Product Code: DWF
• 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,health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RA-2117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 51 YR