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

Catalog Number	412310406
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is pending completion.Upon completion of the investigation a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received regarding a td torque-line catheter, 7f, 4 lumen 110 cm, lf that experienced cracking and rupture.The reporter stated that they use this product knowing that the worst-case scenario is that the balloon will rupture when inflated and only use this product in patients that absolutely need it because of a latex allergy.However, they have never seen a balloon break into fragments.The event date was on (b)(6) 2025.There was patient involvement, there was a delay in the critical therapy when the problem was noted, there was no serious deterioration in the state of health or death of patient.
Additional Manufacturer Narrative
The reported complaint balloon broke was confirmed on the returned set.During visual inspection a tear was observed on the balloon of the td catheter.It is unknown how and when the tear had occurred on the balloon.The probable cause of the tear on the balloon is unknown.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, LF
• 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: 21660260
• Report Number: 1713468-2025-00002
• Device Sequence Number: 8940157
• Product Code: DQE
• UDI-Device Identifier: 00840619043681
• UDI-Public: (01)00840619043681(17)250501(10)13955634
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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 Expiration Date: 05/01/2025
• Device Catalogue Number: 412310406
• Device Lot Number: 13955634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2024
• 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