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

Model Number PR9

Device Problems Inflation Problem (1310); Leak/Splash (1354)

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

Event Date 03/10/2014

Event Type  malfunction  

Event Description

It was reported that there was "issue with balloon inflation or there may be leak.Proplege coronary sinus catheter, pr9 was given to perfusion who was not exactly sure of what happened in the case.".

Manufacturer Narrative

The device evaluation is anticipated upon product return from the customer.

Manufacturer Narrative

It was reported that there was "issue with balloon inflation or there may be leak.Pr9 was given to perfusion who was not exactly sure of what happened in the case" evaluation: the complaint that the balloon would not inflate was unable to be confirmed.The returned device was evaluated and found to have a kink in the shaft at 83mm distal from the tip of the device.The balloon lumen was tested and was unable to be flushed.Edwards has in place a technical summary related to this reported failure.Trends for this issue are in control and will continue to be monitored.Manufacturing records were reviewed and there were no related ncr's found.There will be no pra or capa initiated at this time.The instructions for use, training and risk control measures are appropriate at this time.Trends will continue to be monitored on through the edwards quality system.

• 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: 3725311
• MDR Text Key: 4329609
• Report Number: 3008500478-2014-00049
• 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: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2014
• Device Model Number: PR9
• Device Lot Number: 59580588
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/10/2014
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2014
• Date Manufacturer Received: 03/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2013
• 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