MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CATH LAB KIT FOR INDUSTRIAL DRUG SUPPLIES, USA; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	011-0J553-01
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	10/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A complaint was received regarding a cath lab kit for industrial drug supplies, usa, that experienced air in line during infusion resulting in a coronary air embolism but no intervention required.The reporter stated that "they have faulty manifold/syringes introducing air in the system.The patient developed coronary air embolism but was luckily stable." the problem occurred during infusion during injecting coronaries.The type of procedure was cardiac catheterization.The length of time the product was in use was 30 minutes.There was no serious injury/death nor blood loss.No chemo leak nor unprotected chemo exposure.No medical/surgical intervention required.The device(s) was changed out/replaced with no further problems encountered.The patient had just pain and ecg changes due to air embolism.The status of the patient was returned to baseline condition.
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01jul2025 has been used as a placeholder.D4, g4: model number is not sold in the us but similar device is sold under model 46100-83.This product was used for the di, product code, and 501k.The device is not available for evaluation.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Corrected information can be found in b3 - date of event.This information was received on 29jul2025.Update information: d9.Investigation summary the complaint could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.Update: 10/8/2025.The reported complaint of air bubbles was not confirmed.Images were provided by the customer showing the involved device.No visual anomalies were observed on the returned set.When the returned set was primed and pressure leak tested, no leaks were observed.The set was pressure leak tested under water; no trace of air bubbles was identified.The product performed per the specifications.The device history record was reviewed, and no nonconformities were found that would have led to the reported complaint.

• Brand Name: CATH LAB KIT FOR INDUSTRIAL DRUG SUPPLIES, USA
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 22800410
• Report Number: 9617594-2025-01675
• Device Sequence Number: 12929325
• Product Code: DQO
• UDI-Device Identifier: 00840619069162
• UDI-Public: 00840619069162
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K932141
• 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): 10/31/2025

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 Expiration Date: 02/01/2026
• Device Catalogue Number: 011-0J553-01
• Device Lot Number: 13539841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown