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

Model Number PR9

Device Problem Inflation Problem (1310)

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

Event Date 12/19/2014

Event Type  malfunction  

Event Description

Edwards received information that during preparation of a proplege catheter, the customer experienced balloon inflation difficulty.The catheter was not used and no patient involvement was reported.

Manufacturer Narrative

The device was not returned to edwards for analysis.Based on the information received, edwards is unable to determine the root cause for this event.A review of the ifu was conducted and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The ifu provides the following warning which address this event: "fill the 3 ml syringe with physiological sterile solution and attach it to the blue stopcock on the balloon inflation port.Inflate the balloon with a maximum of 1.4 ml of physiological sterile solution to verify proper inflation".Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

Additional manufacturer narrative: the device was returned to edwards for analysis and the complaint condition was confirmed.During visual inspection, an obstruction was identified in the balloon lumen 10 cm from the distal tip.At this section, the shaft manifested a surface artifact and constriction.The lumen was exposed revealing a significant narrowing of the balloon lumen.A review of the device history records (dhr) revealed no non-conformities related to the reported event.Based on the device evaluation, it was determined that a manufacturing related issue contributed to this event and corrective actions were performed to address the issue.A product risk assessment for this failure mode was determined to be of low risk to the patient.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: 4428633
• MDR Text Key: 5417852
• Report Number: 3008500478-2015-00010
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2014

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: 06/01/2015
• Device Model Number: PR9
• Device Lot Number: 59778698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 01/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2014
• 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