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	08/08/2024
Type of Reportable Event	Malfunction
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 using the new icu medical thermodilution catheters during a procedure, was unable to obtain accurate waveform despite troubleshooting (i.E.New transducer and changing channel cables).It was also stated that "attempted to use another pressure cable, but still unreliable waveforms noted.Replaced transducer cable off the manifold, but still obtained inaccurate waveform readings.The physician was not able to complete the procedure and is questioning the results.The reporter stated, "to my knowledge, the reading wasn¿t corresponding to the patient's clinical status at the time of use.The patient was not affected during the use of the product.".
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
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.When the returned set was primed and pressure leak tested, no occlusions/ leaks were observed.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.Updated information in d9.

• 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: 20467754
• Report Number: 9617594-2024-01462
• Device Sequence Number: 12604775
• 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): 12/09/2024

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?: Device Returned to Manufacturer
• 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: 12/09/2024
• 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