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); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 06/12/2019

Event Type  Injury  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe, three three-way stopcocks and one pressure tubing set was returned for evaluation.One string was attached to the catheter body at 70.5 cm proximal from the catheter tip.Clotted blood was observed from the catheter.Balloon did not inflate due to leakage from a puncture, approximately 2 mm, on the catheter body at 70.3 cm proximal from the catheter tip.Leakage was also found from the puncture when air was injected into the thermistor and thermal filament lumens.All through lumens were patent without any leakage or occlusion.No visible damage or abnormality was found from the balloon, returned syringe, optical module connector, thermal filament connector and thermistor connector.Blood was not observed from the puncture or inside the thermistor or thermal filament lumen.Balloon inflation test was performed using returned syringe with 1.5 cc air.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.Customer report of balloon inflation issue was confirmed during the analysis; however, the balloon was not found to be ruptured.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 states in the ifu to ¿check for balloon integrity.Inflate the balloon to the recommended volume and check for major asymmetry and for leaks by submerging in sterile saline or water.¿ it is unknown if user factors may have contributed to the 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

Initially it was reported that the balloon of the swan ganz catheter ruptured when the patient¿s body was moved during use and consequently, the pulmonary artery (pa) was injured on the second day of use.The catheter was placed in the left pa after urgent percutaneous coronary intervention (pci) and the patient was transferred to icu.On the second day of the catheter placement, there was a resistance when the balloon was inflated to measure pulmonary artery wedge pressure (pawp).Hemoptysis and deterioration of oxygenation were observed.X-ray examination revealed permeability loss at the proximal left pa.The catheter was removed from the patient.The customer confirmed that the balloon did not inflate and considered that balloon rupture occurred.Information such as what treatment the patient received for pa injury was requested but could not be obtained.The severity was determined by the doctor as serious, however, there was no risk of death or disability and extension of hospitalization.The patient¿s outcome was determined as recovered at ten days from the injury.

Manufacturer Narrative

Corrected data: f10, h6.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: 8750770
• MDR Text Key: 149763665
• Report Number: 2015691-2019-02407
• 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
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2020
• Device Model Number: 746F8
• Device Catalogue Number: 746F8
• Device Lot Number: 61561764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 48