MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER; CATHETER, FLOW DIRECTED

Device Problems Material Rupture (1546); Component Missing (2306); Physical Resistance/Sticking (4012)

Patient Problems Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477); Foreign Body In Patient (2687)

Event Date 09/23/2020

Event Type  malfunction  

Event Description

Prior to insertion of right ij (right internal jugular) swan ganz catheter via introducer, catheter was placed to flush bag.Ports were flushed and balloon was inflated without difficulty.Fellow noted that swandom was not applied to catheter.Applied swandom -- balloon inflation not completed after applying swan condom.Fellow began to insert swan.Certified registered nurse practitioner (crnp) inflated balloon with resistance.Balloon deflated and fellow inserted swan farther.Swan waveform and numbers did not appear correct, so swan was removed.Upon removal of swan, balloon was not present on the end of the catheter.It is difficult to ascertain if there is a small part of the balloon on the tip; but it appears as if the entire balloon is non-existent.A new swan catheter was readied and inserted by fellow and crnp.As new swan was being inserted rn noted decreasing o2 sats.Sat's continued to decrease to 60's-70's and heart rate decreased to 50's.Anesthesia stat paged for intubation.Patient became unresponsive -- bagged with 100% fio2.Anesthesia intubated without difficulty.Decreased blood pressure with continued decrease heart rate.Attending md at bedside.Levo drip started, low dose epi push, and one amp bicarb given with good blood pressure response.

• Brand Name: SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 12452415
• MDR Text Key: 270871487
• Report Number: 12452415
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28835 DA