MAUDE Adverse Event Report: SORIN GROUP USA, INC. AORTIC ROOT CANNULA WITH VENT LINE, 12G STERILE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number AR-11112

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 01/08/2015

Event Type  Other  

Event Description

Sorin group rec'd a report that the surgeon had difficulty removing the stylet from the cannula after insertion into the pt.There was no reported pt injury.

Manufacturer Narrative

The investigation is ongoing.A f/u report will be sent when the investigation is completed.

Manufacturer Narrative

Sorin group received a report that the surgeon had difficulty removing the stylet from the cannula after insertion into the patient.There was no reported patient injury.It was initially reported that the issue was with the stylet, but investigation uncovered that it was actually the needle that was difficult to remove.The involved aortic root cannula was not returned for evaluation, but a cannula from the same lot was returned by the customer for the same reported issue (reference medwatch report 1718850-2015-00014).The returned cannula was evaluated along with a sample pulled from inventory, which was used for comparison.During functional testing, it was found that the needle of the returned cannula was more difficult to remove than that of the unit pulled from inventory.Visual inspection of the returned device revealed excess solvent at the tubing connection for the luer attachment, and measurements taken of the two cannula confirmed that the returned cannula had a smaller inner diameter than the unit pulled from inventory, which caused the reported issue.The reported issue was caused by a manufacturing error.The individuals responsible for assembling and inspecting this cannula were gathered together, the manufacturing operating procedure was reviewed, and the possible causes for this issue were discussed to ensure that the proper steps needed for this build are clearly understood.No trend has been identified and a correction has been performed.Sorin group will continue to monitor the market for trends related to this issue.Customer unable to return.

Manufacturer Narrative

The event date provided in the initial report was incorrect.The correct event date is (b)(6) 2015.

• Brand Name: AORTIC ROOT CANNULA WITH VENT LINE, 12G STERILE
• 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: 4528428
• MDR Text Key: 5409837
• Report Number: 1718850-2015-00015
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K972503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: AR-11112
• Device Lot Number: 1425100076
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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