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

Model Number C146F7

Device Problems Break (1069); Deflation Problem (1149); Material Rupture (1546)

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

Event Date 03/17/2022

Event Type  malfunction  

Event Description

Elderly female with latex allergy have a right heart cath.Latex free swann broke while it was in the patient.Physician had the balloon in the patient and then it lost air.Swann removed without known injury and another one was used successfully.Please note that this is #13 reported for the same product, same balloon rupture.Manufacturer response for catheter, intravascular, diagnostic, swan-ganz controlcath (per site reporter).Will obtain.

• Brand Name: SWAN-GANZ CONTROLCATH
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 13844675
• MDR Text Key: 287618571
• Report Number: 13844675
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00690103153132
• UDI-Public: (01)00690103153132(17)240131(11)220131(10)64169837
• 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: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• 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: 64169837
• 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: 03/17/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Female