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

Catalog Number	412320402
Medical Device Problem Codes	Material Rupture (1546); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The event involved a td catheter, 8f, 5 lumen, 110cm, ra/rv, heparin coated, lf where the customer stated that the registered nurse (rn) collected morning pa numbers around 06:30.Upon inflation of the balloon, the catheter achieved only a partial wedge.After releasing the inflation valve, the balloon did not passively deflate.The rn was able to manually aspirate the air from the balloon and subsequently notified the charge rn for further evaluation.When the charge rn inspected the catheter, it appeared to be intact and inflated the balloon.When the charge rn reinspected the catheter, rn noted blood back flowing into the syringe.Md and ccr fellow md was immediately notified of the suspected balloon rupture and it was promptly removed.A chest x-ray was also ordered and performed.The patient denied any shortness of breath and appeared to be in his usual state of health. there was patient involvement, unknown delay in therapy reported, no human harm though there was a need for increased monitoring.
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not complete.
Additional Manufacturer Narrative
The following was provided by the customer for complaint investigation: one used list # 412320402, td catheter, 8f, 5 lumen, 110cm, ra/rv, heparin coated, lf; lot #unknown.--> one used list #unknown, purple connector; lot #unknown.The reported complaint of leak on the balloon was confirmed.An image was provided by the customer showing the involved device in a plastic bag.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.A dhr lot # review could not be conducted because no lot number was identified.Corrected information can be found in b1 - adverse event/product problem, b2 - outcomes attributed to ae, b6 - relevant test/laboratory data, d10 concomitant products, d2a - common device name, d3 - manufacturing plant country, e4 - initial report sent to fda, h1 - type of reportable event, h4 - device mfg date null, h6 health effect - impact code, h6 medical device problem code and h6 component code.

• Brand Name: TD CATHETER, 8F, 5 LUMEN, 110CM, RA/RV, 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.
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21977640
• Report Number: 9617594-2025-00927
• Device Sequence Number: 9188747
• Product Code: DQE
• UDI-Device Identifier: 00840619043704
• UDI-Public: 00840619043704
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 412320402
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED SYRINGE, MFR UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown