MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ CCO/VIPTHERMODILUTION CATHETER WITH AMC THROMBOSHIELD; CATHETER, CONTINUOUS FLUSH

Model Number 139HF75P

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2015

Event Type  malfunction  

Event Description

It was reported that the balloon would not deflate without the syringe.The catheter was then tested and it gave no signal.The reported catheter was not used in the patient; there was no patient consequences.

Manufacturer Narrative

The device evaluation is anticipated.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 examination results.

Manufacturer Narrative

We received one 139hf75 catheter and a 1.5ml monoject syringe 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 returned syringe attached.All through lumens were patent without any leakage or occlusion.The catheter ran cco in 37.0 c water bath on vigilance ii monitor for 5 minutes with no error.Resistance value of thermal filament circuit was measured and found to be within specification.The thermistor and thermal filament circuit were continuous; there were no open or intermittent conditions.No visible inconsistencies were observed on the eeprom data.Both the thermistor and thermal filament connectors were opened and found no visible inconsistencies.In addition, there were no visible damages observed from the catheter body or 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 CCO/VIPTHERMODILUTION CATHETER WITH AMC THROMBOSHIELD
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 4632766
• MDR Text Key: 5759217
• Report Number: 2015691-2015-00694
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K924661
• 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,Followup
• Report Date: 02/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2015
• Device Model Number: 139HF75P
• Device Lot Number: 59784743
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2014
• 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