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

Model Number 41239-06

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2019

Event Type  malfunction  

Event Description

Swan ganz balloon ruptured during procedure - no harm.

• Brand Name: TD TORQUE-LINE CATHETER
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): ICU MEDICAL, INC; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 8276859
• MDR Text Key: 134071394
• Report Number: 8276859
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 41239-06
• Device Lot Number: 91-854-SL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1