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

Model Number 131HF7

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2014

Event Type  malfunction  

Event Description

It was reported that there was a small white particle fixed on the surface of the swan ganz catheter.The white particle was noted as the catheter was being prepped for insertion.The catheter was exchanged for a new swan ganz catheter and there was no patient injury.

Manufacturer Narrative

We received one 131hf7 catheter for examination.Examination was performed prior to decontamination.There was a small white, soft substance stuck to the catheter body 46cm proximal of the catheter tip.Chemistry testing found the substance showed similar absorption characteristics when compared to butadiene-acrylonitrile copolymer like material.A review of the manufacturing records indicated that the product met specifications upon release.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 ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 4245732
• MDR Text Key: 17690193
• Report Number: 2015691-2014-02667
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2015
• Device Model Number: 131HF7
• Device Lot Number: 59704536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2014
• 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