MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. MERIT CUSTOM KIT

Catalog Number K08-02004

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2023

Event Type  Injury  

Event Description

The account alleges that during a vascular procedure, air was observed at the inlet junction of the contrast device and was inadvertently injected into the patient causing an air embolization within the coronary arteries.Medical intervention [risordan] was deemed necessary and administered by the attending physician.The device was discarded at the account and will not be returning for investigation.

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A lot number has been provided.A follow up will be submitted when the dhr is complete.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: MERIT CUSTOM KIT
• Type of Device: CUSTOM 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 bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 16857275
• MDR Text Key: 314438586
• Report Number: 1721504-2023-00042
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450179956
• UDI-Public: 884450179956
• 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: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: K08-02004
• Device Lot Number: H2555756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• 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): Required Intervention; Life Threatening