MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. MERIT CUSTOM KITS; CARDIOVASCULAR PROCEDURE KIT

Catalog Number K09-10402C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 09/12/2022

Event Type  Injury  

Event Description

The account alleges that during a coronarography there was air present in the check relief valve of the manifold which results in air being injected into the patient.Patient suffered from air embolism.

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Manufacturer Narrative

The suspect device was not returned for investigation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be re-opened.Multiple attempts have been made to contact the complainant to better understand the circumstances surrounding the alleged event.The response from the customer is that they will no longer communicate with merit medical regarding these incidents.

• Brand Name: MERIT CUSTOM KITS
• Type of Device: CARDIOVASCULAR PROCEDURE KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 15499134
• MDR Text Key: 300721741
• Report Number: 1721504-2022-00092
• Device Sequence Number: 1
• Product Code: OEZ
• UDI-Device Identifier: 00884450236642
• UDI-Public: 884450236642
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: K09-10402C
• Device Lot Number: H2248850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening