MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS LIFESCIENCES SWAN-GANZ THERMODILATION CATHETER; CATHETER, FLOW DIRECTED

Model Number 931F75

Device Problems Break (1069); Difficult to Flush (1251); Leak/Splash (1354); Difficult to Remove (1528); Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/02/2023

Event Type  Injury  

Event Description

A 70 yo m adm(admitted) (b)(6) 2023 as a transfer from an outside hospital for nstemi.Heart cath at outside hospital showed need for cabg.Plan is for cabg/maze/clip by cardiothoracic surgery on (b)(6) 2023.On (b)(6) 2023, pt enters the operating room at 1431 and surgery begins at 1523.Notes from anesthesiologist states swan functioning normally prior to going on bypass.At 1855: preparing to come off bypass and noticed the transducer was leaking a little and pap reading.Attempted to aspirate the swan with the thought of a blood clot from the leaking transducer, but unable to aspirate or flush.Swan was backed up 2 cm thinking it could possibly be hyper-wedged in the pa, but this did not help.The catheter was very easy to backup.We thought at the time the inability to aspirate was from blood that traveled up the swan.Pt came off bypass uneventfully and was very stable.1950: we decided to switch out the swan and investigate after removal.Swan replaced in sterile fashion.Swan was removed after re-checking that balloon was down and was pulled without any resistance.New swan placed and floated into the pa with continued sterile conditions; 2000: evaluated swan and found to have about 5 cm missing from the end.The wire that measures cardiac output was still intact, but the plastic covering including the balloon was missing.The end of the catheter had a pinched appearance with the wire sticking out.Cts informed of the situation and we began discussing the best solution.We explored with tee, and possibly thought it might be near the pulmonic valve, but ultimately that was a shadow of the catheter.Cts very gently evaluated the right atrium and could not feel the catheter.Fluoro was called and it appeared the remnant of catheter was possibly in the svc? cts called ir and we all discussed the options of the best way to retrieve the piece.It was decided to let the patient recover overnight from his cabg and ir would remove in the morning.We asked about the risk of movement and ir felt that it was very low and very reasonable to wait until the morning.Chest was closed and pt left intubated overnight in icu.Operative note states " intraoperative discussion with ir md and conclusion was given the fact that the patient was immediately coming off bypass and relatively unstable that it would be best to stabilize the patient in the icu and do the procedure to remove the catheter in the morning in the ir suite.Once the chest was closed anesthesiologist and i went out to the waiting room and discussed the results of the operation and the missing swan tip and plan for retrieval with the wife and family." (b)(6) 2023 0958-1108 ir procedure performed "oblique fluoroscopy was performed, revealing that this catheter fragment is not within the superior vena cava as had been initially communicated, but rather is in the right pulmonary artery.Therefore, we negotiated the guidewire and catheter through the heart into the right pulmonary artery.Attempts to snare the catheter fragment with a loop snare were not successful.Therefore, an inari t24 large bore aspiration thrombectomy catheter was placed into the right lower lobe and after 3 aspiration pulls, we were successful in retrieving the catheter fragment and this was removed from the body without incident." on (b)(6) 2023 d/c home and instructed to follow up with cardiology outpatient.

• Brand Name: EDWARDS LIFESCIENCES SWAN-GANZ THERMODILATION CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC
• MDR Report Key: 17011127
• MDR Text Key: 316110554
• Report Number: MW5117920
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 931F75
• Device Catalogue Number: 7.5 F (2.5 MM)
• Device Lot Number: 64848610
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White