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

Model Number PR9

Device Problem Inflation Problem (1310)

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

Event Date 01/30/2014

Event Type  malfunction  

Event Description

It was reported that the proplege (pr9) malfunctioned during use.It was reported "i tightened all connections, flushed open ports with heparinized saline, and mixed 1/2 contrast, 1/2 hep.Saline for the balloon preparation, as instructed.When i tried to inflate the balloon, it required an immense amount of pressure to inflate balloon and on deflation, the balloon did not easily deflate.I removed the stopcock and flushed (which flushed with ease) and attempted to inflate the balloon without the stopcock.I had the same result.At this point, i decided to open another catheter prior to patient entering the o.R.Suite and discarded the malfunctioning coronary sinus catheter.Two circulators witnessed the events described." i tightened all connections, flushed open ports with heparinized saline, and mixed 1/2 contrast, 1/2 hep.Saline for the balloon preparation, as instructed.

Manufacturer Narrative

Device evaluation pending product receipt.

Manufacturer Narrative

The device was returned for analysis.The clinical observation was confirmed.Visual inspection of the returned found no kinks or bends in the catheter body.Air was used to attempt to inflate balloon and was unable to inflate balloon.Water also was used to attempt to inflate balloon and was also unable to inflate balloon.The root cause of the reported balloon inflation difficulty is most likely a result of the customer using a contrast ratio that is not indicated for use in the ifu.The device has not been designed or tested to perform with a 1:1 contrast ratio.No manufacturing defect could be identified.No capa is applicable.The instructions for use, training, and risk control measures are appropriate at this time.Trends will continue to be monitored through the edwards quality system.

Manufacturer Narrative

Device was not returned by hospital for evaluation.It was reported that the proplege (pr9) malfunctioned during use.It was reported "i tightened all connections, flushed open ports with heparinized saline, and mixed 1/2 contrast, 1/2 hep.Saline for the balloon preparation, as instructed.When i tried to inflate the balloon, it required an immense amount of pressure to inflate balloon and on deflation, the balloon did not easily deflate.I removed the stopcock and flushed (which flushed with ease) and attempted to inflate the balloon without the stopcock.I had the same result.At this point, i decided to open another catheter prior to patient entering the o.R.Suite and discarded the malfunctioning coronary sinus catheter.Two circulators witnessed the events described." evaluation: since the device in question was not returned, any manufacturing defect with the device cannot be assessed.The complaint was unable to be confirmed.The root cause of this complaint may be due to the customer using a contrast ratio that is not indicated for use in the ifu.Manufacturing records were not able to be reviewed due to the fact that no lot number was provided.The trend for this complaint type is in control.There will be no pra or capa initiated for this event.The ifu, labeling, 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: 3632920
• MDR Text Key: 3990148
• Report Number: 3008500478-2014-00027
• 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: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PR9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2014
• Date Manufacturer Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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