MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC TRUWAVE; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number	PX284AN
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Early 60¿s male with history of coronary artery disease and recent shortness of breath.7 days post op from coronary artery bypass graft x 1 and monitored in cvicu.A new package of truwave 3cc pressure tubing opened to change arterial line.When the tubing was primed, tubing was wet and there was a puddle on the floor.A crack was visualized in the tubing and the tubing was removed, without known harm to patient.Manufacturer response for transducer, pressure, catheter tip, truwave (per site reporter) will obtain.

• Brand Name: TRUWAVE
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 16843322
• Report Number: 16843322
• Device Sequence Number: 15168764
• Product Code: DXO
• UDI-Device Identifier: 07460691950245
• UDI-Public: (01)07460691950245(17)240908(11)220909(10)64603249
• 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): 04/18/2023
• Report Date (Section F): 04/18/2023

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: PX284AN
• Device Catalogue Number: PX284AN
• Device Lot Number: 64603249
• 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: 05/01/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 88 KG
• Date Report Sent to FDA: 04/18/2023