MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR CATHETER/INTRODUCER COMBO SYSTEM; CATHETER, FLOW DIRECTED

Model Number K9FC146F7

Device Problem Deflation Problem (1149)

Patient Problem No Information (3190)

Event Date 02/04/2014

Event Type  malfunction  

Event Description

It was reported that the catheter would not deflate.It is unknown if the inflation syringe was removed from the gate valve or not.

Manufacturer Narrative

Attempts have been made of the hospital for additional information regarding the event and condition of the patient.Per hospital policy the device will not be released for evaluation.If additional information and or the device history review becomes available a follow-up submission will be submitted.The hospital medwatch number- (b)(4).

• Brand Name: CATHETER/INTRODUCER COMBO SYSTEM
• Type of Device: CATHETER, FLOW DIRECTED
• 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 ; 9497564386
• MDR Report Key: 3790996
• MDR Text Key: 4366295
• Report Number: 2015691-2014-01028
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K9FC146F7
• Device Lot Number: 59465826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 54 YR