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

Catalog Number K09-10716C

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

Patient Problems Air Embolism (1697); Ischemia (1942); ST Segment Elevation (2059)

Event Date 03/29/2018

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that air was accidentally injected into the patient's artery during a percutaneous transluminal diagnostic coronary angiogram.The staff was training a new tech during this procedure.The tech was unaware that the stopcock located on the contrast line leading to the manifold was not closed allowing air to be aspirated into the coronary control syringe.The air went unnoticed by the staff and was injected into the patient's coronary artery resulting in temporary st elevation (air embolism) on the patient's ecg.The staff continued to monitor the patient's vital signs throughout the rest of the procedure.No further complications have been reported.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.Based on the information provided by the account the root cause is attributed to use error.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and one similar complaint from the same customer was found for this lot number.

• Brand Name: MERIT CUSTOM KIT
• Type of Device: CUSTOM KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit parkway; south jordan 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit parkway; south jordan 84095
• Manufacturer Contact: katie swenson, cqe, cba, cqpa ; 1600 w merit parkway; south jordan 84095 ; 8012081600
• MDR Report Key: 7421614
• MDR Text Key: 105156019
• Report Number: 1721504-2018-00031
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: K09-10716C
• Device Lot Number: H1279556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2018
• 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