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

Catalog Number 777F8

Device Problems Component Missing (2306); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 pa catheter stopped reading co and ci.Noted missing prong on the cco port of the pa cath.On (b)(6) 2022: pa catheter with sudden loss of waveform with no pa pressure or cvp reading in ccu last week.No catheter migration noted.Module/cables switched out and routine troubleshooting was completed with no resolution.Md notified and catheter dc'd per orders.No patient harm.Similar occurrence reported by anesthesiology in or in the cabg patients with pa cath abruptly not displaying pa and cvp waveform/reading and having to replace catheters as a result.Fda safety report id #(b)(4).

• Brand Name: SWAN-GANZ CCOMBO V PA CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; irvine CA 92614
• MDR Report Key: 15716219
• MDR Text Key: 303050518
• Report Number: MW5113041
• Device Sequence Number: 2
• 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: 10/31/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 777F8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2022
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White