MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY DILATION ATRIOSEPTOSTOMY CATHETER; FOGARTY CATHETER

Model Number 830705F

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2014

Event Type  malfunction  

Event Description

It was reported that "it was difficult to inflate or deflate the balloon before use." there were no patient complications reported.

Manufacturer Narrative

One fogarty dilation catheter without the packaging was returned for evaluation.No syringe was returned.No visual damage to the catheter body or balloon was observed.The balloon inflated clear and concentric without leakage when inflated with 3.6ml air.The syringe was removed and the balloon deflated within specifications in 3 seconds.The balloon was again inflated using 1.8ml water and again the balloon inflated clear and concentric and did not leak.The syringe was removed and the balloon deflated within specifications in 14 seconds.Visual examinations were performed with the unaided eyes.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.The complaint of deflation difficulty could not be confirmed during the analysis, as the device responded appropriately during functional testing.No further actions will be taken at this time.

• Brand Name: FOGARTY DILATION ATRIOSEPTOSTOMY CATHETER
• Type of Device: FOGARTY CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9492504386
• MDR Report Key: 3679366
• MDR Text Key: 4301602
• Report Number: 2015691-2014-00605
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 830705F
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/14/2014
• 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