MAUDE Adverse Event Report: MERIT MEDICAL SYSTEM IRELAND MERIT S-MAK¿.COAXIAL STIFF MINI ACCESS KIT.; MICRO ACCESS KIT

Catalog Number	S-MAK501N15BT
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A supplemental report will be submitted once the evaluation is complete.
Event or Problem Description
The account alleges that during a microvascular access attempt, the access wire unraveled in the patient.No patient injury to report, the device was removed with no additional medical intervention needed, and a new wire was used for this procedure.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually and the complaint is confirmed.No definitive root cause could be determined.A review of the complaint database was performed and no similar complaints for this lot number were identified.A review of the device history record was performed and no exception documents were found.

• Brand Name: MERIT S-MAK¿.COAXIAL STIFF MINI ACCESS KIT.
• Common Device Name: MICRO ACCESS KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEM IRELAND; parkmore business park west; ballybrit,; galway ; EI
• Manufacturer (Section G): MERIT MEDICAL SYSTEM IRELAND; parkmore business park west; ballybrit,; galway ; EI
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012088662
• MDR Report Key: 18938072
• Report Number: 9616662-2024-00013
• Device Sequence Number: 12484314
• Product Code: DRE
• UDI-Device Identifier: 00884450155066
• UDI-Public: 00884450155066
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 03/13/2024

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-MAK501N15BT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACCESS SHEATH.
• Patient Sex: Unknown