MAUDE Adverse Event Report: ICU MEDICAL, INC. 8F TRIOX SVO2 PA CATHETER

Model Number 50328-07

Device Problems Difficult to Insert (1316); Kinked (1339); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2016

Event Type  malfunction  

Manufacturer Narrative

Findings: the involved 50328-07 catheter was not returned for analysis and confirmation.The triox catheter is a precision optical instrument and must be handled with care.Kinking, excessive manipulation, or grasping with forceps or hemostats can permanently damage the fiberoptics, reducing the transmission of light to and from the blood.Care should also be taken to remove any slack or loops in the catheter as this can also lead to migration.The 50328-07 catheter was pre-tested prior to placement with no issues detected at that time.The exact cause(s) of the reported event/product issue are unknown.Device not returned.

Event Description

Medsun report received concerning insertion/kinking problems with use of one 50328-07 8f triox svo2 pa heparin coated catheter.The medsun report describes the (b)(6) 2016 event as follows " 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".The involved device was removed, discarded and replaced.The 50328-07 catheter was pre-tested prior to placement with no issues detected at that time.Additional event/device usage information although requested was unavailable.

• Brand Name: 8F TRIOX SVO2 PA CATHETER
• Type of Device: TRIOX SVO2 PA CATHETER
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer (Section G): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 5498713
• MDR Text Key: 40304583
• Report Number: 2025816-2016-00017
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K06299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 50328-07
• Device Catalogue Number: 50328-07
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2016
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 57