MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ UNKNOWN; SWAN GANZ CATHETER

Model Number SWAN GANZ UNKNOWN

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.A device history record review was completed and documented that the device met all specifications upon distribution.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

As reported, during use in the patient, this swan ganz catheter kinked during insertion at around the 12cm mark.When the catheter was being removed from the patient, there was resistance with the cordis sheath.The sheath and catheter had to be removed together, resulting in the need to insert a new central iv access at the end of the case.Unfortunately, further information was not available.There was no allegation of patient injury; however, the patient had some ectopy during the attempts to remove the catheter.The device is available for evaluation.Multiple attempts have been made to obtain patient demographics, but no information has been received.

Manufacturer Narrative

Information was received that the product is no longer available for evaluation, as initially expected.Without the return of the product, it is not possible to determine if damages or defects existed on the product.No actions will be taken at this time.Invasive procedures inherently involve some patient risks.Although serious complications associated with pulmonary artery catheters are relatively uncommon, the physician is advised before deciding to use the catheter to consider and weigh the potential benefits and risks associated with the use of the catheter against alternative procedures.The general risks and complications associated with indwelling catheters are well documented in the literature.It is unknown if procedural factors may have contributed to the reported event.

Manufacturer Narrative

Previously, it was reported that the device was not expected to be returned for evaluation.Since the date of that report, the device was returned and evaluated.We received one swan ganz catheter with a non-edwards introducer, non-edwards contamination shield and monoject limited volume syringe.The report of catheter kinked at 12cm mark was confirmed.Visual examination found a kink on the catheter body 12cm proximal of the distal tip.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.All through lumens were patent without any leakage or occlusion.The catheter was inserted into the returned non-edwards introducer and passed the introducer freely.When removing the catheter from the introducer, resistance was felt when the balloon latex passed the introducer hub.The catheter passed freely through the entire length of a lab sample 8.5f introducer.The catheter was easily removed from the lab sample introducer.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.Two possible lot numbers were reported.A device history record review was completed and documented that device met all specifications upon distribution.Lot no.60605101, expiration date 10/27/2018; manufacture date 10/31/2016 lot no.60579718: expiration date 10/6/2018; manufacture date 10/10/2016.

• Brand Name: SWAN-GANZ UNKNOWN
• Type of Device: SWAN GANZ CATHETER
• 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: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 6499025
• MDR Text Key: 72987166
• Report Number: 2015691-2017-01036
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K934742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SWAN GANZ UNKNOWN
• Device Lot Number: 60605101 OR 60579718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2017
• 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