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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER AND KIT (FOR SUPERIOR VENA CAVA INSERTION)

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EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER AND KIT (FOR SUPERIOR VENA CAVA INSERTION) Back to Search Results
Model Number PEK074F5
Device Problem Material Rupture
Event Date 12/09/2016
Event Type  Malfunction  
Manufacturer Narrative

One bipolar pacing catheter without any attached components was returned for evaluation. Balloon was found to be ruptured at the central area of the balloon latex. The ruptured edge of the latex was not able to match up. Visual examination was performed under microscope at 20x magnification and with the unaided eyes. A device history record review was completed and documented that device met all specifications upon distribution. The customer report of balloon inflation issue was confirmed. An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions. Invasive procedures involve some patient risks. Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications. The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature. It is common clinical practice to check balloon integrity by inflating it to the recommended volume in order to detect any asymmetry or leakage condition before use of the catheter. When there is separation of the balloon or fragments from the pulmonary artery catheter, the retained fragment will embolize to the lungs. Due to the large surface area of the pulmonary vasculature, this is generally well tolerated. Pulmonary complications may result from improper inflation technique. To avoid damage to the pulmonary artery and possible balloon rupture, the balloon should not be inflated above the recommended volume.

 
Event Description

It was reported that the balloon inflated once at the balloon inflation test, however, when the customer attempted to inflate the balloon again before insertion, the balloon ruptured. There were no patient complications reported. Patient demographic information requested but unavailable.

 
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Brand NameSWAN-GANZ BIPOLAR PACING CATHETER AND KIT (FOR SUPERIOR VENA CAVA INSERTION)
Type of DevicePACING 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
lynn selawski
1 edwards way
irvine , CA 92614
9497564386
MDR Report Key6271298
Report Number2015691-2017-00164
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 12/12/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/23/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/25/2018
Device MODEL NumberPEK074F5
Device LOT Number60385889
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/25/2016
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/26/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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