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

Model Number C146F7

Device Problem Burst Container or Vessel (1074)

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

Event Date 04/04/2023

Event Type  malfunction  

Event Description

Early 50¿s year old female with history of hypertension and recent chest pain.During the right heart procedure, the balloon at the end of the catheter burst.Another swan used without further difficulty.No known harm to patient.This is #15 report for the same product.Manufacturer response for catheter, intravascular, diagnostic, swan-ganz control cath (per site reporter).

• 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: 16742442
• MDR Text Key: 313317203
• Report Number: 16742442
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00690103153132
• UDI-Public: (01)00690103153132(17)250224(11)230225(10)64753916
• 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: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• 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: 64753916
• 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: 04/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18615 DA
• Patient Sex: Female
• Patient Weight: 85 KG