MAUDE Adverse Event Report: EDWARDS LIFESCIENCES VASCUSHUNT (WITH STOPCOCKS) SILICONE BALLOON SHUNT; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number T3103AS

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: the device was not returned to edwards for evaluation.The clinical observation was unable to be confirmed.A definite root cause cannot be determined at this time.The instructions for use (ifu) was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.No further corrective or preventative actions are required.Edwards will continue to review and monitor all events through the use of edwards quality systems.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received information that during preparation of a carotid shunt a leak was noted and the balloon would not inflate.There was no patient injury do to this event.

Manufacturer Narrative

Additional manufacturer narrative: per the engineering evaluation, the packaging and handling/preparation conditions were not reported, so it is unknown if the product damage was caused during shipping or as the device was being prepared for use.A definitive root cause could not be identified.A manufacturing, supplier, design, ifu, and labeling defect was not confirmed.

Manufacturer Narrative

A pin hole leakage was found on the device when inflating the 15mm balloon (blue valve).The 9mm (white valve) balloon inflated clear, concentric and remained inflated for 5 min without leakage.All through lumens were patent without any leakage or occlusion.No other visual damage, contamination, or other abnormalities were found on product.Customer report of leakage was confirmed.Engineering evaluation has been opened and assigned for further investigation.A supplemental report will be submitted upon completion.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.

• Brand Name: VASCUSHUNT (WITH STOPCOCKS) SILICONE BALLOON SHUNT
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irivne CA 92614
• Manufacturer Contact: neil landry ; one edwards way; mle2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 7142311
• MDR Text Key: 95794915
• Report Number: 3008500478-2017-00053
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K860988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2017

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: 04/01/2019
• Device Model Number: T3103AS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 01/16/2018; 02/26/2018
• Supplement Dates FDA Received: 01/30/2018; 02/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2016
• 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