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

Model Number PR9

Device Problem Hole In Material (1293)

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

Event Date 06/30/2014

Event Type  malfunction  

Event Description

As reported by our colleagues in (b)(4), the balloon of a proplege coronary sinus catheter does not inflate.It has a hole somewhere in the line / balloon from the start.It was tested before insertion and it never hold pressure.Sample will be returned for evaluation.

Manufacturer Narrative

Device evaluation anticipated upon receipt.

Manufacturer Narrative

Device evaluation: the device was returned to edwards for evaluation.The clinical observation could not be confirmed.As received, the device performed as intended.During visual inspection of the returned device there were no kinks, bends or deformities observed on device.Air was flushed through balloon lumen and balloon inflated as intended.Water was flushed through balloon lumen and the balloon inflated as intended.The device was submerged in water bath and inflated with 10cc of air and there were no visible leaks.No leakage was noted.

• Brand Name: PROPLEGE CORONARY SINUS CATHETER
• 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: 3929863
• MDR Text Key: 4530823
• Report Number: 3008500478-2014-00105
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K120780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2014

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 Model Number: PR9
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2014
• Initial Date Manufacturer Received: 09/24/2014
• Initial Date FDA Received: 07/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/26/2014
• 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