MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ VIP OXIMETRY TD CATHETER WITH AMC THROMBOSHIELD; CATHETER, OXIMETER, FIBEROPTIC

Model Number 782HF75

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2014

Event Type  malfunction  

Event Description

It was reported that the catheter was displaying low cardiac output and cardiac index readings when compared to svo2 and fick calculations.The patient may have been treated for inaccurate low cardiac output values.No patient injury reported.

Manufacturer Narrative

The device evaluation is anticipated.However the complaint could not be confirmed without the completion of the product evaluation.Lot number was not provided, therefore, review of the manufacturing records could not be completed.A supplemental report will be sent when the investigation is complete.(b)(4).

Manufacturer Narrative

We received one oximetry catheter with an monoject 3ml limited volume at 1.5ml syringe for examination.The catheter passed invitro calibration on the vigilance ii monitor.Catheter also passed transmission and cross-talk testing.There were no open or intermittent conditions.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.All thru-lumens were tested and found to be patent without any leakage.No visible damage was observed from the returned monoject 1.5cc limited volume syringe.The catheter body was examined and found to be in good condition.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 VIP OXIMETRY TD CATHETER WITH AMC THROMBOSHIELD
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• 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: 4409952
• MDR Text Key: 5303646
• Report Number: 2015691-2015-00075
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K926450
• 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,Followup
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 782HF75
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2014
• 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