MAUDE Adverse Event Report: ICU MEDICAL, INC. TRIOX PULMONARY ARTERY CATHETER; CATHETER, PULMONARY, FIBEROPTIC

Model Number 50328-07

Device Problems Kinked (1339); Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem No Code Available (3191)

Event Date 01/26/2016

Event Type  malfunction  

Event Description

A pulmonary artery catheter was inserted in a patient for a lung transplant.The catheter kinked and could not be removed nor advanced.The cordis had to be removed to get the kinked pulmonary catheter out.

• Brand Name: TRIOX PULMONARY ARTERY CATHETER
• Type of Device: CATHETER, PULMONARY, FIBEROPTIC
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 5412483
• MDR Text Key: 37539963
• Report Number: 5412483
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 50328-07
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 57