MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC - SJ MERIT S-MAK¿.COAXIAL MINI ACCESS KIT.; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Catalog Number	S-MAK401N
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports, the patient presented for a tavr procedure.After placing an incision into the skin near the left femoral access site, while removing the sheath they noticed only a piece of the micro access sheath came out and not the entire sheath.Vascular surgery came down and an angiogram was performed.Nothing was obstructing the blood flow in the artery.The piece was not visualized in the left common femoral artery angiogram.Vascular said because there is good blood flow, and the risks of exploring the groin surgically outweigh the benefits, no further intervention is needed.The sheath is embedded in the subcutaneous tissues.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device be returned later, the investigation will be reopened.

• Brand Name: MERIT S-MAK¿.COAXIAL MINI ACCESS KIT.
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC - SJ; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC - SJ; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton r.n. ; 1600 merit pky; south jordan, UT 84095 ; 8012665654
• MDR Report Key: 20858465
• Report Number: 1721504-2024-00083
• Device Sequence Number: 8628139
• Product Code: DRE
• UDI-Device Identifier: 00884450012635
• UDI-Public: 884450012635
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: S-MAK401N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown