MAUDE Adverse Event Report: ICU MEDICAL, INC. TD TORQUE-LINE CATHETER, 7F, 4 LUMEN, 110 CM; CATHETER, OXIMETER, FIBER-OPTIC

Catalog Number	412310405
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
It was reported that a td torque-line catheter, 7f, 4 lumen, 110 cm was found to provide inaccurate readings during patient use.The reporter stated that after the first thermodilution catheter failed the physician attempted to obtain cardiac outputs once again with a new thermodilution catheter and cable.Still unable to obtain outputs because temperature readings were not within range.It was also stated that the case ended because no cardiac outputs could be obtained, unable to calculate valve area to evaluate for aortic stenosis and possible need for valve replacement.
Additional Manufacturer Narrative
The reported complaint of no readings was not confirmed on the returned set.No visual anomalies were observed.The balloon was tested and performed as expected.The electrical characteristics of the thermistor was measured and found to be within the product specifications.The temperature reading was able to be obtained from the catheter and the set performs per the product specifications.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TD TORQUE-LINE CATHETER, 7F, 4 LUMEN, 110 CM
• Common Device Name: 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: 20468100
• Report Number: 1713468-2024-00006
• Device Sequence Number: 12642286
• Product Code: DQE
• UDI-Device Identifier: 00840619043674
• UDI-Public: 00840619043674
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 412310405
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/02/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown