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 Dyspnea (1816)

Event Date 04/14/2021

Event Type  malfunction  

Event Description

Elderly female with history of hypertension, diabetes, and asthma.Admitted for shortness of breath, procedure right and left heart catheterization.Edwards representative was present to observe and her recommendation was to use an 8.5f sheath.An 8.5f sheath was used and the latex free swan balloon burst.Device removed in its entirety and no known harm to patient.Typically, the surgeons use a 7f sheath (their preference) and on the device packaging it recommends using an 8.5f sheath.8.5f sheath was used for procedure and balloon of swan broke.This is the 7th latex free swan balloon that burst.Invasive heart catheter lab, cardiovascular operating room, and purchasing were informed of lot numbers from all 7 instances the balloon broke.

• 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: 11731721
• MDR Text Key: 247545261
• Report Number: 11731721
• Device Sequence Number: 1
• Product Code: DYG
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Weight: 80