MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. K09 CONTRAST MEDIUM INJECTION MANIFOLD KIT; MERIT CUSTOM KIT

Catalog Number K09-07811

Device Problem Crack (1135)

Patient Problem Air Embolism (1697)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that a (b)(6) patient diagnosed with coronary artery disease [cad] was admitted for a rotating thrombectomy with angioplasty procedure of the posterior descending (pda) and circumflex [cx] arteries.During the interventional procedure, the pressure ramp had split, and a minimal amount of air was accidentally injected into the patient's coronary artery.Clinical staff assigned to the procedure did not notice the damaged device until the air was identified during fluoroscopic imaging and blood was noted to be leaking from the damaged device.The physician attempted to aspirate the air embolism from the patient's artery.The physician exchanged the damaged device for a new one and completed the procedure without any additional consequences to the patient.

Manufacturer Narrative

The suspect device has been returned for evaluation.The device was examined visually.The complaint is confirmed.The root cause is attributed to the manufacturing process.A search of the complaint database was performed and no similar complaints about this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: K09 CONTRAST MEDIUM INJECTION MANIFOLD KIT
• Type of Device: MERIT CUSTOM KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 10938640
• MDR Text Key: 219308149
• Report Number: 1721504-2020-00100
• Device Sequence Number: 1
• Product Code: OES
• UDI-Device Identifier: 00884450165904
• UDI-Public: 884450165904
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2023
• Device Catalogue Number: K09-07811
• Device Lot Number: H1894718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 70 YR