MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number PR9

Device Problem Deflation Problem (1149)

Patient Problem Not Applicable (3189)

Event Date 06/04/2015

Event Type  malfunction  

Event Description

Edwards received information that during preparation of a peripheral retrograde cardioplegia device, it was noticed the balloon would not fully deflate.The device was prepped according to the instructions for use (ifu) for a robotic mitral valve replacement (mvr) procedure.There was no patient involvement reported.

Manufacturer Narrative

Device evaluation is pending.A supplemental mdr will be filed when the evaluation is complete.

Manufacturer Narrative

No device failure detected.Additional manufacturer narrative: the device was returned for evaluation and the reported complaint ¿the balloon would not fully delate¿ was not confirmed.During visual examination, there was no visual damage, contamination or pertinent abnormality found on the device.The balloon of the device was inflated without any issues and deflated successfully according to the instructions for use (ifu).A review of the device history record (dhr) revealed no non-conformities related to the device.A manufacturing defect was not confirmed.Based on the information provided, a definitive root cause could not be determined.A review of the ifu was conducted and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The complaint trend was assessed and found to be in control.No further action is required at this time.Trends will continue to be monitored through the use of edwards quality systems and if action is required, appropriate investigation will be performed.

• Brand Name: PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak parkway; draper UT 84020
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 12050 lone peak parkway; draper UT 84020
• Manufacturer Contact: walter wiegand ; 12050 lone peak parkway; draper, UT 84020 ; 8015655200
• MDR Report Key: 4878767
• MDR Text Key: 6042738
• Report Number: 3008500478-2015-00042
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2015

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: 04/01/2016
• Device Model Number: PR9
• Device Lot Number: 60063576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2015
• Initial Date FDA Received: 06/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2015
• 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