MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ THERMODILUTION CATHETER WITH AMC THROMBOSHIELD; PROBE, THERMODILUTION

Model Number 131HF7P

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2015

Event Type  malfunction  

Event Description

As reported, drawing blood from the swan ganz catheter was not possible at the end of a right heart catheterization.The hospital usually draws a sample of blood from the distal lumen of the swan ganz catheter and analyzes it, but in this case it was not possible to do so.When the catheter was extracted, a textile fiber was found on the introducer.The introducer is not an edwards device.There is no allegation of patient injury.

Manufacturer Narrative

The device evaluation is anticipated.However the complaint could not be confirmed without the completion of the product evaluation.A supplemental report will be forthcoming with evaluation and device history results.

Manufacturer Narrative

We received one 131hf7 catheter for examination and a fiber taped to a cloth for examination.All thru-lumens were tested and found to be patent without any leakage.The thermistor was found to read 37.0°c when submerged in a 37.0°c water bath.There were no open or intermittent conditions.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.No visible damage was observed from the returned monoject 1.5cc limited volume syringe.The catheter body was examined and found to be undamaged.Chemistry testing of the unknown fiber like material showed similar absorption characteristics when comparing to nylon like materials.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.A review of the manufacturing records indicated that the product met specifications upon release.

• Brand Name: SWAN-GANZ THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
• Type of Device: PROBE, THERMODILUTION
• 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: 4822546
• MDR Text Key: 5898779
• Report Number: 2015691-2015-01315
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K811411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2016
• Device Model Number: 131HF7P
• Device Lot Number: 59912593
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2014
• 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