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

Model Number	00884450387320
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2019
Type of Reportable Event	Malfunction
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 a percutaneous transluminal coronary intervention [pci] procedure, the physician had acquired retrograde arterial access and had negotiated the patient's aorta with a guidewire and guide catheter to successfully cannulate and opacify the coronary vascular system.The account states that following a balloon angioplasty, air was identified within the injection manifold.The manifold syringe was pulled back and a crack was identified at the control syringe connection port.A new manifold was prepped per industry protocol, and the procedure continued.Air was not identified -under fluoroscopic imaging- entering the patient during this procedure.The physician then noted two new filling defects within the patient's artery.The patient became progressively hypotensive and a code blue was initiated.Return of spontaneous circulation (rosc) was successfully achieved and the procedure continued.Seventeen minutes later, the patient coded again.The team was not able to recover the patient.The patient expired on the procedure room table.The account alleges that the cause of death was an anterior wall myocardial infarction, secondary to thrombosis of a high-grade left anterior descending [lad] coronary artery atherosclerotic plaque.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.

• 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: 9679257
• Report Number: 1721504-2020-00006
• Device Sequence Number: 14146735
• Product Code: OEZ
• UDI-Device Identifier: 00884450387320
• UDI-Public: 00884450387320
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 00884450387320
• Device Catalogue Number: K09-00378AA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER; GUIDE WIRE .014; INFLATION DEVICE; PTCA BALLOON