MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ POLYMER BLEND TRUE SIZE C-TIP CONTROLCATH TD CATHETER WITH AMC THROMBO; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number C144HF7

Device Problems Deflation Problem (1149); Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2015

Event Type  malfunction  

Manufacturer Narrative

We received one c144hf7 catheter with monoject 3ml syringe with limited volume at 1.5ml for examination.The reported event of balloon deflation and pressure issues was not confirmed.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.The balloon deflated within 2 seconds without a syringe attached.As stated in the ifu ¿passively deflate the balloon by removing the syringe from the gate valve¿.The balloon failed to deflate fully with returned syringe attached.All through lumens were patent without any leakage or occlusion.No visible damage was observed from the catheter body or the returned monoject 1.5cc limited volume syringe.Lot number was not provided, therefore review of the manufacturing records could not be completed.The reported event was not confirmed.Although the cause of the complaint could not be determined, there was no indication of a manufacturing defect noted during the analysis.No actions will be taken at this time.

Event Description

It was reported that when testing the catheter prior to use, the balloon of the catheter did not deflate with and without the syringe attached to the gate valve.On the other hand, the pressure values provided were not correct according to the patient status, however, no alarm or error message was displayed on the monitor.The issue was solved by changing the catheter for another one.The patient was not treated according to the pressure values provided, thus there was no allegation of patient injury.

• Brand Name: SWAN-GANZ POLYMER BLEND TRUE SIZE C-TIP CONTROLCATH TD CATHETER WITH AMC THROMBO
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 5129804
• MDR Text Key: 27553090
• Report Number: 2015691-2015-02623
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K915726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Report Date: 09/10/2015

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: C144HF7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2015
• 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