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

Model Number 131F7

Patient Problem Pain (1994)

Event Date 07/21/2023

Event Type  malfunction  

Event Description

Elderly male with past history of cardiac disease.Procedure: right heart cath and stenting.7f swan-ganz was inserted via the 7f sheath in the right femoral vein.There was difficulty advancing the swan.The x-ray was panned down to the right groin area and a knot in the swan.The decision was made to remove the sheath and swan together in attempt to untie the knot.The swan broke into two pieces as the sheath was removed.Vascular surgeon performed cutdown and removed the knotted swan under local anesthetic.Patient discharged the next day without known harm.Difficulty obtaining right femoral venous access.Once access was obtained, a 7f sheath was inserted.The 7f swan-ganz was inserted via the 7f sheath in the right femoral vein.There was difficulty advancing the swan.An 0.25 wire was inserted to help advance the swan.The swan was not advancing.The x-ray was panned down to the right groin area and a knot in the swan was seen.An attempt was made to untie the knot.The decision was made to remove the sheath and swan together in attempt to untie the knot.The swan broke into two pieces as the sheath was removed.A portion of the swan was sticking out of the patient's skin.The knot was still in the right femoral vein.Access was obtained in the left femoral vein and a 10f sheath was inserted.A snare was inserted via the 10f sheath in the left femoral vein in an attempt to remove the knot.The snare was able to grab the knot, but the knot was unable to move across to the left groin.This was too painful for the patient.A 7f sheath was inserted in the right femoral vein over the piece of swan that was sticking out of the patient's skin.Dr 1, vascular surgeon, entered the procedure.He exchanged the 7f sheath in the right femoral vein for a 16f sheath.The snare was re-inserted in the 16f sheath in the right femoral vein.The knot could not be removed via the 16f sheath.The knot could not be removed via the 16f sheath.The cvor (cardiovascular operating room) team entered the procedure.Dr 1 was needed in a case in the hybrid or.Dr2, vascular surgeon, entered the case to relieve dr 1.Dr 2 performed a vascular cut down on the right femoral vein and the swan knot was retrieved.This was all done under local anesthetic to the right groin.Manufacturer response for catheter, intravascular, diagnostic, swan-ganz (per site reporter), will obtain.

• Brand Name: SWAN-GANZ
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 17449980
• MDR Text Key: 320307647
• Report Number: 17449980
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00690103000405
• UDI-Public: (01)00690103000405(17)250509(11)230510(10)65067168
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/28/2023,07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 131F7
• Device Catalogue Number: 131F7P
• Device Lot Number: 65067168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 33215 DA
• Patient Sex: Male