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

Catalog Number	K09-10889C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Visual Impairment (2138)
Date of Event	06/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that the patient was evaluated and treated for cad.Post pci procedure, the patient complained of left arm weakness and was positively diagnosed with an embolic stroke in recovery unit.The patient was successfully treated and discharged to home with loss of peripheral vision and weakness in the arm.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The product was examined visually.The complaint could not be confirmed.No definitive root cause could be determined.A search of the complaint database found three similar complaint for this lot number from the same customer.The device history record was reviewed, and no exception documents were found.

• Brand Name: CUSTOM MANIFOLD KIT
• Common Device Name: MERIT CUSTOM KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 15115009
• Report Number: 1721504-2022-00065
• Device Sequence Number: 14841171
• Product Code: OEZ
• UDI-Device Identifier: 00884450403983
• UDI-Public: 884450403983
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/21/2025
• Device Catalogue Number: K09-10889C
• Device Lot Number: H2327245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 09/18/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACCESS SHEATH; GUIDE CATHETER; INTERVENTIONAL BALLOON; INTERVENTIONAL GUIDWIRE .014
• Outcome Attributed to Adverse Event: Disability; Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Unknown