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 05/09/2014

Event Type  malfunction  

Event Description

It was reported that during the use of a proplege coronary sinus catheter, pr9 "no ventricular tracing through the pressure line.Steering mechanism not working.The introducer was placed in the usual fashion.On prep the ratchet handle was working fine and the pressure line flushed fine.The catheter was placed under tee guidance and visualized in the cs.They added 1/2 cc of volume to the balloon and had no ventricular waveform so they added another 1/4cc and still had no waveform.They took out the volume and advanced and re introduced volume and never got a tracing.They also changed out and flushed all the transducers and had no pressure tracing.They also visualized the catheter in the rv when they made adjustments and didn't get an rv waveform.Upon removal of the catheter was also noted at that point that the steering mechanism on the handle wasn't moving when they adjusted the positions.The case was a mini avr.No patient injury.The case proceeded with antegrade cp.

Manufacturer Narrative

Device evaluation is currently underway into root cause.

Manufacturer Narrative

Evaluation: visual inspection of the returned device found that there were no kinks, bends, or other deformities in the catheter.All three lumens were flushed and leak tested with no difficulties.It was found that the device would not articulate through any of the seven articulation points.Upon opening the device handle it was found that the articulation wire was not attached to the articulation switch.The complaint that the device would not articulate was confirmed.The root cause of this complaint is a manufacturing defect.The root cause of the flow issues is unable to be determined.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.

Manufacturer Narrative

Device evaluation: a review of the information evaluated in this event found that the reported articulation difficulty was due to a detached pull wire.A definitive root cause for the detached pull wire could not be determined.The root cause of the flow issues reported may be related to poor placement resulting from the articulation issue but could not be confirmed.Trends will continue to be monitored 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: 3850961
• MDR Text Key: 20717962
• Report Number: 3008500478-2014-00079
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2014
• Device Model Number: PR9
• Device Lot Number: 59703321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2014
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/09/2014
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2014
• Date Manufacturer Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2014
• 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: 57 YR