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

Model Number	C146F7
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of coronary artery disease and hypertension.Procedure: right and left diagnostic heart catheterization.Latex free swan used for procedure and it ruptured.It was removed intact, and another latex free swan used for procedure.It ruptured as well.#3 latex free swan was used successfully to complete the procedure.No known harm to patient - patient discharged the same day.Please note that this is #10 and #11 of the latex free swans reported that the balloons broke.2021-8058, 2021-8085,2021-8110,2021-8008,2021-8009, 2021-8014, 2021-8022,2021-8050,2021-8052,20-8902 manufacturer response for catheter, intravascular, diagnostic, swan-ganz controlcath (per site reporter) will obtain.Manufacturer response for catheter, intravascular, diagnostic, swan-ganz controlcath (per site reporter) will obtain.

• Brand Name: SWAN-GANZ CONTROLCATH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 12868390
• Report Number: 12868390
• Device Sequence Number: 6119830
• Product Code: DQO
• UDI-Device Identifier: 00690103153132
• UDI-Public: (01)00690103153132(17)231101(11)211101(10)63967892
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/17/2021
• Report Date (Section F): 11/17/2021

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
• Operator of Device: Health Professional
• Device Model Number: C146F7
• Device Catalogue Number: C146F7
• Device Lot Number: 63967892
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/24/2021
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 65 KG
• Date Report Sent to FDA: 11/17/2021