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

Catalog Number AR-11014

Device Problems Kinked (1339); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The cannula was saved for return, however, the patient's blood borne pathogen status could not be confirmed.The cannula will not be returned for evaluation.Sorin group received a report that the tip of the aortic root cannula bent and became kinked during an aortic valve replacement procedure.The surgeon reported difficulty in delivering cardioplegia and venting the aorta.The cannula was replaced and the procedure was completed without further issue.On august 15, 2016, sorin group usa received a user medwatch report ((b)(4)) for this component.This medwatch report is being filed in response to the receipt of the user report.The customer provided a photograph showing the soft distal tip of the cannula bent at a 90° angle at the location of the punched holes in the tip.The photograph was not taken during a case, but rather was modeled after the reported event.The customer stated that it is unknown if the cannula actually bent a full 90° during the case.The customer pointed out that the punched holes in the tip were oriented perpendicular to the direction of blood flow, and alleged that the blood flow was enough to bend over the tip.The cannula was saved for return, however, the patient's blood borne pathogen status could not be confirmed and the complained device was not returned for evaluation.Based on the reported lot number, cannula tips representative of the complained unit were pulled from sorin receiving inspection retains for dimensional analysis.Twenty (20) soft distal tips were measured at three different critical dimensions.All of the measurements were within specification.This aortic root cannula tip is used in a number of sorin cannula products.Since the beginning of manufacture of this product line at sorin group usa, over 110,000 tips have been consumed in the production and distribution of product.This is the first report of this type of issue.As the product could not be returned, the root cause was not determined and corrective actions were not identified.Sorin group will continue to monitor for trends related to this type of issue.

Event Description

Sorin group received a report that the tip of the aortic root cannula bent and became kinked during an aortic valve replacement procedure.The surgeon reported difficulty in delivering cardioplegia and venting the aorta.The cannula was replaced and the procedure was completed without further issue.On august 15, 2016, sorin group usa received a user medwatch report ((b)(4)) for this component.This medwatch report is being filed in response to the receipt of the user report.

• Brand Name: AORTIC ROOT CANNULAE
• 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: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5945574
• MDR Text Key: 54528497
• Report Number: 1718850-2016-00389
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972503
• 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: 08/15/2016

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: 04/30/2019
• Device Catalogue Number: AR-11014
• Device Lot Number: 1611700013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/15/2016
• Initial Date FDA Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2016
• 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: 69 YR
• Patient Weight: 108