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

Model Number PR9

Device Problems Deflation Problem (1149); Inflation Problem (1310)

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

Event Date 03/05/2014

Event Type  malfunction  

Event Description

It was reported by the clinical specialist that the proplege, pr9 balloon would not inflate/deflate while prepping.

Manufacturer Narrative

Device evaluation is currently underway into root cause.

Manufacturer Narrative

It was reported by the clinical specialist that the proplege, pr9 balloon would not inflate/deflate while prepping.Evaluation: the device was evaluated and was found to have a kink and crack in the balloon lumen approximately 2cm from the hub.The complaint that the balloon would not inflate or deflate was confirmed.The root cause of the kink and crack in the device was indeterminable.Trends for this issue are in control and will continue to be monitored.Manufacturing records were reviewed and there were no related nonconformances 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: 3705751
• MDR Text Key: 4264190
• Report Number: 3008500478-2014-00046
• 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: 03/05/2014

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: 04/01/2014
• Device Model Number: PR9
• Device Lot Number: 59636045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/05/2014
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2014
• Initial Date Manufacturer Received: 03/05/2014
• Initial Date FDA Received: 03/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2013
• 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