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

Model Number	00884450298022
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	07/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during an angioplasty procedure, the custom kit presented a defect that caused air ingress into the fluid pathway.Air bubbles were then injected into the right coronary artery causing st segment elevation as seen on the ecg.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.Functional testing was performed.The complaint is confirmed.The root cause is attributed to the kinking of the fluid tubing caused by the incorrect connection of an additional medical device not is part of the k09 kit [use error].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.

• Brand Name: MERIT CUSTOM KIT
• Common Device Name: CUSTOM KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 12199196
• Report Number: 1721504-2021-00060
• Device Sequence Number: 4173355
• Product Code: OEQ
• UDI-Device Identifier: 00884450298022
• UDI-Public: 00884450298022
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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: 02/07/2024
• Device Model Number: 00884450298022
• Device Catalogue Number: K09-10402CP
• Device Lot Number: H2053625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention