MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TD CATHETER, 8F, 5 LUMEN, 110 CM, RA/RA, HEPARIN COATED, LF; CATHETER, OXIMETER, FIBER-OPTIC

Catalog Number	412330402
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a td catheter, 8f, 5 lumen, 110 cm, ra/ra, heparin coated, lf where the customer reported that they were attempting to reposition pulmonary artery catheter (including balloon inflation) at the bedside due to waveform abnormality.The catheter was not able to be repositioned correctly and coiled in the patient's heart which was confirmed via chest x-ray.The customer attempted repositioning the pulmonary artery catheter (pac) under fluoroscopy, they could not visualize balloon, so the catheter was removed and replaced and upon visual inspection the balloon ruptured.There was patient involvement but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The reported complaint of tear on the balloon was confirmed.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.Lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: TD CATHETER, 8F, 5 LUMEN, 110 CM, RA/RA, HEPARIN COATED, LF
• Common Device Name: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21990804
• Report Number: 9617594-2025-00956
• Device Sequence Number: 8312246
• Product Code: DQE
• UDI-Device Identifier: 00840619043735
• UDI-Public: (01)00840619043735
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/08/2025

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 Catalogue Number: 412330402
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 05/08/2025
• 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