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

Model Number PR9

Device Problem Material Rupture (1546)

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

Event Date 01/14/2014

Event Type  malfunction  

Event Description

It was reported by the sales rep that a pr9 proplege balloon ruptured.

Manufacturer Narrative

Device will be evaluated upon receipt.

Manufacturer Narrative

There are many possible root causes of the reported rupture/leakage of the device.It is unlikely that the root cause is related to a manufacturing non conformance as the device maintained occlusion and tested well during prep.It is unlikely that the root cause is related to a design deficiency.It is possible that the root cause is related to a specific incident during the procedure such as overinflation, damage during prep, or a needle strike by the physician.From the available information root cause cannot be determined.Requests for additional information were not returned.Manufacturing records, instructions for use and training records were reviewed for this device and there were no additional concerns.Trends remains in control.Trends will continue to be monitored through the edwards quality system and any new information will be reviewed for further analysis.

• Brand Name: PROPLEGE
• 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: 3589531
• MDR Text Key: 4030306
• Report Number: 3008500478-2014-00009
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2014,01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PR9
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/14/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2014
• Date Manufacturer Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: No
• 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