MAUDE Adverse Event Report: ICU MEDICAL, INC. TRIOX¿ SVO2/CCO PA CATHETER, 8F, 110CM, J-TIP, LF; CATHETER, OXIMETER, FIBER-OPTIC

Catalog Number 52516-15

Device Problems Unable to Obtain Readings (1516); Unintended Movement (3026)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/22/2023

Event Type  Injury  

Manufacturer Narrative

The device has been requested to be returned for evaluation; however, it has not yet been received.

Event Description

The incident involved an unspecified pulmonary artery (pa) catheter.It was reported that during use of this pa catheter with cogent on a patient post heart procedure, the patient was moved from the bed to the chair.During this time, they lost all function of the catheter including svo2, cco/cci and body temp.During this time, the catheter also moved from the pa to the right ventricle (rv) causing the patient to go into ventricular fibrillation and have to be shocked and chest compressions for resuscitation.The product was used for 24 hours.No medication was being used with the product.The product was not reprocessed or re-sterilized prior to use.There was patient involvement, and harm reported, and there was delay in therapy.

Manufacturer Narrative

Device received by manufacturer on 16-aug-2023.

Event Description

The customer provided updated information on 17-aug-2023 to provide the identification of the item.The catheter in use during the incident was a triox¿ svo2/cco pa catheter, 8f, 110cm, j-tip, lf.

Manufacturer Narrative

The reported complaint of all the functionality of the catheter is lost was confirmed on the returned set.No visual anomalies were observed on the returned set.The balloon was tested and performed as expected.A pre-insertion calibration test was conducted, and the received sample could not be calibrated.A light was shined across the tip of the catheter to determine if light was still visible on the opmod connector of the catheter and light was visible on both the fiber optic strands.Since the light was visible on both fiber optics, the likely cause of the pre-insertion calibration would be typical of a hair line crack at some point along the length of the fiber optics internal in the catheter.The electrical characteristics of the thermistor was tested and it was observed that the temperature reading was not able to obtained.When the white housing was cut open, two of the wires were observed to be broken.This broken wire would lead no temperature readings.Without the temperature readings, the thermocoil would not be able to function and a cco value would not be obtained.Testing and analysis of the returned 52516-15 triox¿ svo2/cco pa catheter confirmed the reported product issue due to fiber optics and thermistor wire damage.The 52516-15 triox¿ svo2/cco pa catheter was pre-tested, inserted and in use for twenty-four hours with no reported functional issues per the product complaint event description.The probable cause(s) of the fiber optics and thermistor wire damage along with the reported catheter migrating from pulmonary artery (pa) to the right ventricle (rv), likely occurred as a result of unintentional manipulation/force when the patient was moved and/or repositioned from the bed to the chair, as described in the event description, directly proceeding the failure of the device.

• Brand Name: TRIOX¿ SVO2/CCO PA CATHETER, 8F, 110CM, J-TIP, LF
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 s. atherton drive; salt lake city UT 84123
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17549398
• MDR Text Key: 321164940
• Report Number: 9617594-2023-00554
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 52516-15
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 08/17/2023; 10/16/2023
• Supplement Dates FDA Received: 09/07/2023; 10/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COGENT MONITORING SYSTEM, ICU MEDICAL
• Patient Outcome(s): Required Intervention; Life Threatening