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

Model Number PR9

Device Problem Inflation Problem (1310)

Patient Problem Not Applicable (3189)

Event Date 11/19/2014

Event Type  malfunction  

Event Description

Edwards received information that during preparation of a proplege catheter the balloon would not inflate.No patient involvement.

Manufacturer Narrative

Device evaluation is pending.Additional manufacturer narrative: a supplemental mdr will be filed when the evaluation is complete.

Manufacturer Narrative

Result - balloon lumen occluded.The device was returned to edwards for evaluation and the reported condition was confirmed.Visual inspection of the returned device found no kinks or other damage in the catheter shaft.The balloon was attempted to be inflated with a 3ml syringe with water but was unsuccessful.During visual examination of the blue stopcock attached to the balloon lumen small crystals were observed on the inside surface of the stopcock lumen.Sectioning of the device found a white crystal-like occlusion in the proximal section of the blue lumen.It is likely the crystalline material is consistent with water-soluble crystallized contrast medium.The root cause of the inflation 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 nonconformances identified.The instructions for use and risk control measures were assessed and are appropriate.Trends will continue to be monitored through the edwards quality system and if action is required, appropriate investigation will be performed.

• Brand Name: PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
• 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: 4331064
• MDR Text Key: 5255900
• Report Number: 3008500478-2014-00148
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2015
• Device Model Number: PR9
• Device Lot Number: 59712667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2014
• 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