MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER; SWAN GANZ THERMODILUTION CATHETER

Model Number 831F75

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2017

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation laboratory received one swan-ganz catheter.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.The balloon deflated within 2 seconds without the returned syringe attached, which is within specifications.As stated in the ifu, ¿passively deflate the balloon by removing the syringe from the gate valve¿.All through lumens were patent without any leakage or occlusion.No visible damage was observed from the catheter body.A device history record review was completed and documented that the device met all specifications upon distribution.The report of "balloon of this swan-ganz catheter did not fully deflate" was not confirmed, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.No actions will be taken at this time.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.The duration of catheterization should be the minimum required by the patient¿s clinical state since the risk of thromboembolic and infectious complications increases with time.The incidence of complications increases significantly with indwelling periods longer than 72 hours.It is unknown if user or procedural factors contributed to this event.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, prior to use in the patient, the balloon of this swan-ganz catheter did not fully deflate.The customer could not confirm if the syringe was attached while trying to deflate the balloon.There was no allegation of patient injury.Patient demographics requested, but not provided.

• Brand Name: SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER
• Type of Device: SWAN GANZ THERMODILUTION 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: 6655219
• MDR Text Key: 78040881
• Report Number: 2015691-2017-01788
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K810352
• 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
• Report Date: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2017
• Device Model Number: 831F75
• Device Lot Number: 60188776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Date Manufacturer Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2015
• 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