MAUDE Adverse Event Report: ICU MEDICAL INC TD THERMODILUTION CATHETER; PROBE, THERMODILUTION

Model Number 41229-02

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2019

Event Type  Injury  

Event Description

Right heart catheter inserted, when catheter was in pulmonary wedge position user was unable to pull blood from inner lumen.Catheter was removed and noted to have ruptured balloon tip.

• Brand Name: TD THERMODILUTION CATHETER
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): ICU MEDICAL INC
• MDR Report Key: 8403412
• MDR Text Key: 138239986
• Report Number: MW5084743
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 41229-02
• Device Lot Number: 90-997-SJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 73