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

Model Number 131HF7J

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2014

Event Type  malfunction  

Event Description

It was reported that "a thin wire-like material which was about 1cm in length was found when the customer opened the package before use."the detail of the location is unknown.".

Manufacturer Narrative

The device evaluation is anticipated.At this time, the complaint cannot be confirmed without the product.A supplemental will be submitted when the product evaluation is complete.A review of the manufacturing records indicated that the product met specifications upon release.

Manufacturer Narrative

One catheter with monoject 1.5 cc limited volume syringe was returned for evaluation.One loose wire-like particulate was returned with the catheter.The particulate measured approximately 20mm long.Further examination found the sample to be a thin wire-like piece of metal with some coating flaking off.The wire od was measured and found to be 0.0035".A lab sample of thermistor wire was removed from the same model catheter and the coating was removed, the od was found to be 0.0035" the same as the returned wire.It appears that a piece of scrap thermistor wire fell into the catheter tray prior to being sealed.Visual examinations were performed under microscope at 10x magnification.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.

• 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 ; one edwards way; irvine, CA 92614 ; 9492504386
• MDR Report Key: 3643072
• MDR Text Key: 4209780
• Report Number: 2015691-2014-00427
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2015
• Device Model Number: 131HF7J
• Device Lot Number: 59587162
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2013
• 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