MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ CONTROLCATH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	C146F7
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Mid 70¿s female with history of coronary artery disease and latex allergy.Procedure: left and right heart catheterization.Swan placed in femoral vein for pressure measurements, balloon ruptured before catheter advanced into heart.Swan removed without known harm to patient, discharged the same day.This is report #14 for the lf swan balloon breakage.Manufacturer response for catheter, intravascular, diagnostic, swan-ganz controlcath (per site reporter).Will obtain.

• Brand Name: SWAN-GANZ CONTROLCATH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 15469996
• Report Number: 15469996
• Device Sequence Number: 4469078
• Product Code: DQO
• UDI-Device Identifier: 00690103153132
• UDI-Public: (01)00690103153132(17)240811(11)220812(10)64520464
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/07/2022
• Report Date (Section F): 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C146F7
• Device Catalogue Number: C146F7
• Device Lot Number: 64520464
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 109 KG
• Date Report Sent to FDA: 09/07/2022