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

Catalog Number	S-MAK501N/A
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is 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 micro puncture wire broke off within the patient.The physician was able to snare the wire successfully to remove it.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually and microscopically.The complaint is confirmed.Root cause is attributed to excessive force applied to the device during use.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints were identified for this lot number.

• Brand Name: MERIT S-MAK¿.COAXIAL MINI ACCESS KIT
• Common Device Name: MERIT S-MAK¿
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 17595922
• Report Number: 3011642792-2023-00053
• Device Sequence Number: 15341496
• Product Code: DRE
• UDI-Device Identifier: 00884450012642
• UDI-Public: 00884450012642
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2023

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: S-MAK501N/A
• Device Lot Number: I2662655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• 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