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

Model Number PR9

Device Problem Hole In Material (1293)

Patient Problem Not Applicable (3189)

Event Date 02/06/2015

Event Type  malfunction  

Event Description

Edwards learned that a customer encountered balloon inflation difficulties during preparation of a peripheral retrograde cardioplegia catheter.During filling the balloon with saline, a hole was noted because saline was leaking out of the balloon.No patient involvement was reported.

Manufacturer Narrative

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

Manufacturer Narrative

Additional manufacturer narrative: the device was returned to edwards for evaluation and the complaint observation was confirmed.Upon receipt, visual and functional testing was performed on the device.There were no visible kinks or damage found on the device during visual examination.A leak was identified at the distal balloon bond.A review of the device history record (dhr) revealed that the product was reworked from a previous manufacturing issue in which investigation and corrective actions were initiated to address the issue.In this case, the returned device was manufactured prior to implementation of the corrective actions.A manufacturing defect was confirmed and the proposed root cause is a missed inspection during the manufacturing process of the returned device.The severity of the event was evaluated and found to be adequate.The complaint trend is in control and no further action is required at this time.Trends will continue to be monitored through the use of edwards quality systems.

• 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: walt wiegand ; 12050 lone peak parkway; draper, UT 84020 ; 8015655200
• MDR Report Key: 4577293
• MDR Text Key: 5552050
• Report Number: 3008500478-2015-00020
• 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,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2015

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: 07/01/2015
• Device Model Number: PR9
• Device Lot Number: 59972465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2015
• Initial Date FDA Received: 03/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2015
• 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
• Patient Outcome(s): Other