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

Model Number PR9

Device Problem Occlusion Within Device (1423)

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

Event Date 02/07/2014

Event Type  malfunction  

Event Description

It was reported that the pr9 would not deliver retrograde."they placed the pr9 in usual fashion using tee for confirmation.5000 units of heparin was given at time the necklines were placed as per our ifu's.Full heparin was given at 8:52 for a total of 29000 units.At 9:25 they tried delivering retrograde and would not delivery.No response and no evidence of plege being delivered." this was during a minimally invasive mitral valve procedure.The surgeon decided to forgo the use of retrograde cardiplegia for the duration of the case.

Manufacturer Narrative

Device will be evaluated upon receipt to manufacturer.

Manufacturer Narrative

Evaluation: upon evaluation of the returned device the coronary sinus pressure lumen was found to be occluded.No manufacturing defect can be confirmed.At this time, there will be no capa or pra performed for this device.Instructions for use, labeling and risk control documents remain appropriate.Manufacturing records were reviewed adn there were no related nonconformances.Trends will continue to be monitored to provide input for future corrective and or preventative action decisions.

• 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: 3696539
• MDR Text Key: 4303672
• Report Number: 3008500478-2014-00041
• 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: 02/25/2014

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: 06/01/2014
• Device Model Number: PR9
• Device Lot Number: 59683520
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/07/2014
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2014
• Initial Date Manufacturer Received: 02/25/2014
• Initial Date FDA Received: 03/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2014
• 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
• Patient Age: 70 YR
• Patient Weight: 67