MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MERIT CUSTOM KIT; CONVENIENCE KIT

Catalog Number K12T-10783A

Device Problems Break (1069); Crack (1135); Air/Gas in Device (4062)

Patient Problems Air Embolism (1697); Arrhythmia (1721)

Event Date 12/12/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.A follow up will be submitted when the evaluation is complete.

Event Description

The customer alleges that the during a coronary angiogram procedure, the manifold within the k12t kit was allowing air into the device.The air was accidentally injected into the patient causing ventricular fibrillation.The patient was defibrillated by the clinical staff and extra pain medications were administered.The leak was identified at the 3-way port closest to the patient.

Manufacturer Narrative

The suspect device has been returned for evaluation.The device was examined visually, and functional testing was performed.The complaint is confirmed.The root cause is manifold damage.It is unknown as to how the damage occured.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
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; parkmore business park west; ballybrit, galway ; EI
• MDR Report Key: 11051626
• MDR Text Key: 223061651
• Report Number: 9616662-2020-00019
• Device Sequence Number: 1
• Product Code: OEZ
• 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: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: K12T-10783A
• Device Lot Number: K1877096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Date Manufacturer Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention