MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS CUSTOM KIT; ANGIOGRAPHY/ANGIOPLASTY KIT

Catalog Number MAP400/A

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

Patient Problem Air Embolism (1697)

Event Date 12/13/2021

Event Type  Death  

Event Description

The account alleges that during a mechanical thrombectomy procedure within the patient's basilar artery, the posterior thumbwheel of the hemodevice/tuohy detached during a manual contrast injection.The physician then removed all interventional equipment from the patient and replace the tuohy device.Post procedure 4 hours later, a small air bubble was identified during ct scan within the patient's distal basilar artery.The next day, (b)(6) 2021, the patient had expired.Physician states that the actual cause of death is unknown.Patient was unconscious and intubated both pre and post procedure.

Manufacturer Narrative

The suspect device has returned for evaluation.A follow up will be submitted when the evaluation is complete.

Manufacturer Narrative

One device was returned for evaluation with the thumb-wheel detached.A photograph was also provided by the account.The device was examined visually and the thumb-wheel was quickly reassembled and functional testing was performed.The returned device was then pressure tested in comparison to another device from inventory.The thumb-wheel detachment could not be replicated with the returned device.The thumb-wheel of unused units from inventory detached when the thumb-wheel was not completely engaged with the threads of the hemo device.The device was built to manufacturing specifications.The root cause is contributed to the thumb-wheel not being completely engaged with the threads of the hemo device during injections.The complaint is confirmed.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and only no similar complaints for this lot number were identified.

• Brand Name: CUSTOM KIT
• Type of Device: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; parkmore business park west; ballybrit, galway ; EI
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS; parkmore business park west; ballybrit, galway ; EI
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; 8012084662
• MDR Report Key: 13370239
• MDR Text Key: 284609392
• Report Number: 9616662-2022-00002
• Device Sequence Number: 1
• Product Code: OEQ
• UDI-Device Identifier: 00884450024430
• UDI-Public: 884450024430
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: MAP400/A
• Device Lot Number: K2259410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 01/27/2022
• Supplement Dates Manufacturer Received: 02/17/2022
• Supplement Dates FDA Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2021
• 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
• Treatment: INTERVENTIONAL GUIDEWIRE; REBAR 18 MICROCATHETER; SOFIA PLUS CATHETER (6F)
• Patient Outcome(s): Death