MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MERIT MAK¿.COAXIAL MINI ACCESS KIT

Catalog Number	MAK401N/D
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A lot number has been provided and a review of the manufacturing history record is in progress.A follow-up report will be submitted once the evaluation is complete.
Event or Problem Description
The account alleges that the catheter was inserted and the access guidewire started to unravel during a procedure on a pediatric patient.No additional information available.

• Brand Name: MERIT MAK¿.COAXIAL MINI ACCESS KIT
• Common Device Name: MERIT MAK¿
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MEXICO; 8830 siempre viva rd #100; san diego, CA 92154
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 17680509
• Report Number: 3011642792-2023-00055
• Device Sequence Number: 15279371
• Product Code: DRE
• UDI-Device Identifier: 00884450008812
• UDI-Public: 00884450008812
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K031691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2026
• Device Catalogue Number: MAK401N/D
• Device Lot Number: I2662585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown