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

Model Number C146F7

Device Problem Material Rupture (1546)

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

Event Date 09/02/2022

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 15469996
• MDR Text Key: 300453842
• Report Number: 15469996
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00690103153132
• UDI-Public: (01)00690103153132(17)240811(11)220812(10)64520464
• 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: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 09/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Female
• Patient Weight: 109 KG