MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE; CLAMP, VASCULAR

Model Number PR9

Device Problems Difficult to Advance (2920); Appropriate Term/Code Not Available (3191)

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

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluation is pending.A supplemental mdr will be submitted when the evaluation is complete.(b)(4).

Event Description

It was reported that an edwards retrograde catheter did not function during a case.Through further investigation, it was learned that the catheter would not advance into the coronary sinus and kinking was noted.The catheter was in the coronary sinus opening and perfectly lined up.Advancement of the catheter would only result in the catheter looping toward the tricuspid valve and not advancing further into the coronary sinus.The device was already on maximal antegrade flexion.Three attempts were made and each time the coronary sinus was successfully engaged; however, the surgical team was unable to occlude and perform a venogram.The catheter was removed and the procedure proceeded with standard cardioplegia.There was no visible kinks on the device after removal.The patient did not sustain any injury due to this event.

Manufacturer Narrative

Device evaluated by manufacturer: as received, there was no visible evidence of a kink found on the device and the device articulated normally.Patency test was performed on all lumens and no leaks or occlusions were found.The balloon was tested and functioned without issues.There was no other visual damage, contamination, or other abnormality found on the device.Based on the product evaluation findings, a product deficiency was not identified.Operational context most likely contributed to this event.The instructions for use (ifu) was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The ifu provides the following warnings: i"f resistance is met, stop and re-evaluate proplege device position.The proplege device should not be advanced if resistance is felt, as doing so would cause the proplege device to bend or buckle.Aggressive advancement in an attempt to engage the ostium may result in perforation or other injury.Continuously monitor the pressure at the tip of the catheter.A pressure change that indicates the catheter has entered the right ventricle should be noted.Do not advance the catheter further if the tip is in the right ventricle as perforation or other injury can occur.The catheter should not be advanced when the tip is in the right ventricle.Additional fluoroscopic views may provide further information concerning catheter position (e.G.30° rao, 30° lao).Recommended for use with a water soluble contrast medium intended and approved for venography."no further corrective or preventative actions are required at this time.Trends will continue to be monitored through the use of edwards quality systems and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.

• Brand Name: PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak parkway; draper UT 84020
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irivne CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; mle2; irvine, CA 84020 ; 9492502289
• MDR Report Key: 6114252
• MDR Text Key: 60422687
• Report Number: 3008500478-2016-00039
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2017
• Device Model Number: PR9
• Device Lot Number: 60543277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2016
• 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