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

Catalog Number	K09-08813L
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); Ischemia Stroke (4418)
Date of Event	09/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device will not be returning for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.
Event or Problem Description
The account alleges that a stemi patient was admitted straight to the interventional cath lab for a percutaneous coronary intervention [pci].A coronary angiography was preformed confirming a clot within the within the patients right coronary artery [rca].An emergent thrombectomy and coronary stent deployment was successfully preformed.While taking the last angiogram of the patient's coronary artery air was accidentally introduced into the system and was injected into the patient's rca.The patient started to display symptoms of a stroke and was transferred to radiology department for computerized tomography (ct) scan and further testing.The account alleges that the air was introduced somehow through the contrast line.The manifold device was hard to use.The event required staff to remember necessary steps to prevent air from entering the system and required tubing to be always vertical during injection.
Additional Manufacturer Narrative
The suspect device will not be returning 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.

• Brand Name: MERIT CUSTOM KIT
• Common Device Name: 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 bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 15599012
• Report Number: 1721504-2022-00098
• Device Sequence Number: 19350878
• Product Code: OEZ
• UDI-Device Identifier: 00884450409114
• UDI-Public: 884450409114
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2022

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: 07/08/2025
• Device Catalogue Number: K09-08813L
• Device Lot Number: H2462931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• 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: CONTROLL SYRINGE AND MANIFOLD; INTERVENTIONAL CATHETER; INTERVENTIONAL GUIDWIRE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Unknown