MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER; SWAN-GANZ CATHETER

Model Number 746F8

Device Problems Inflation Problem (1310); Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and three three-way stopcocks was returned for evaluation.The balloon was found to be ruptured and the ruptured edges were not able to match up.All through lumens were patent without any leakage or occlusion.No other visible damage or abnormality to the catheter body or returned syringe was observed.Balloon inflation test was performed using returned syringe with 1.5 cc air by holding the balloon under water.Visual examination was performed under microscope at 20x magnification.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Customer report of balloon issue was confirmed during the evaluation.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.To avoid damage to the pulmonary artery and possible balloon rupture, the balloon should not be inflated above the recommended volume.When there is fragments from the swan ganz catheter, the retained fragment will embolize to the lungs.Due to the large surface area of the pulmonary vasculature, this is generally well tolerated, but can lead to complications such as infection or small infarction.In this case, the balloon rupture occurred outside of the patient¿s body.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

It was reported that the balloon did not maintain its inflation during use.It was further reported that the balloon ruptured outside of the patient body.The catheter was removed when the customer noticed the balloon could not maintain its inflation.The balloon was inflated outside of the body to check, the condition when the balloon ruptured.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

The lot number was obtained and a device history record review was completed and documented that device met all specifications upon distribution.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER
• Type of Device: SWAN-GANZ CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8287630
• MDR Text Key: 134873981
• Report Number: 2015691-2019-00302
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2020
• Device Model Number: 746F8
• Device Catalogue Number: 746F8
• Device Lot Number: 61386778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 01/29/2019
• Supplement Dates Manufacturer Received: 03/01/2019; 07/23/2020
• Supplement Dates FDA Received: 03/05/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1