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

Model Number PR9

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

Patient Problem Not Applicable (3189)

Event Date 08/13/2014

Event Type  malfunction  

Event Description

Edwards received information that the balloon on this device would not inflate or deflate during device preparation.Another device was used.The was no patient involvement reported.Date of event is unknown at this time.Request for event date confirmation and additional information are pending a response from the user facility.

Manufacturer Narrative

Device evaluation is in progress.

Manufacturer Narrative

The clinical observation was confirmed.Visual inspection of the returned device found no kinks, bends, or deformities in the catheter shaft.The balloon was found to be partially inflated during visual inspection and an attempt to remove air from the balloon was unsuccessful.An attempt to flush the balloon lumen was also unsuccessful.Blockages in the form of a clear/whitish crystalline material were found to be completely occluding the lumen.The crystalline material is consistent with water-soluble crystallized contrast medium.The root cause of the inflation and deflation difficulty is unable to be determined; however it is possible that an application issue in relation to this crystalline material could have contributed.Manufacturing records were reviewed and there were no related manufacturing non conformances identified.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.

• Brand Name: PROPLEGE CORONARY SINUS CATHETER
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak pwy; draper UT 84020
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 12050 lone peak parkway; draper UT 84020
• Manufacturer Contact: walter ; 12050 lone peak parkway; draper, UT 84020 ; 8015655200
• MDR Report Key: 4082510
• MDR Text Key: 21529259
• Report Number: 3008500478-2014-00119
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 120780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/13/2014

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: 07/01/2014
• Device Model Number: PR9
• Device Lot Number: 59683519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 09/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2014
• 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