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 04/05/2021

Event Type  malfunction  

Event Description

Elderly female with history of hypertension, stage iii chronic kidney disease and recent chest pain and shortness of breath.While having a diagnostic heart cath, the balloon of the swan ruptured and was removed intact.A new swan was inserted, without known harm to the patient.

• 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: 11633425
• MDR Text Key: 244406752
• Report Number: 11633425
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00690103153132
• UDI-Public: (01)00690103153132(17)230305(11)210305(10)63662592
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/06/2021

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
• Device Operator: Health Professional
• Device Model Number: C146F7
• Device Catalogue Number: C146F7
• Device Lot Number: 63662592
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29565 DA
• Patient Weight: 88