MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHIELD; CATHETER, FLOW DIRECTED

Model Number 746HF8

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2015

Event Type  malfunction  

Event Description

It was reported that the catheter failed to deflate before use, both with and without the syringe attached.There was no report of patient complications.

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint could not be confirmed without the completion of the product evaluation.A review of the manufacturing records indicated that the product met specifications upon release.A supplemental report will be forthcoming with evaluation results.

Manufacturer Narrative

We received one (b)(4) catheter with 3ml monoject syrine with limited volume at 1.5m for examination.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.The balloon deflated in 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 the 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.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.

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
• 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: 4880341
• MDR Text Key: 5863818
• Report Number: 2015691-2015-01576
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2016
• Device Model Number: 746HF8
• Device Lot Number: 59978191
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2015
• 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