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

Catalog Number	S-MAK401N/C
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow-up report will be submitted once the evaluation is complete.
Event or Problem Description
The account alleges that while attempting to acquire vascular acces via the patients jugular vein with an access needle and 0.018 guidewire into the patients superior vena cava, the last cm of the guidewire detached and hooked onto the papillary muscle of the heart.The guidewire was successfully extracted with a vascular snare device causing no additional patient consequences.
Additional Manufacturer Narrative
The suspect device was returned for evaluation and examined visually and microscopically.The complaint is confirmed.Root cause is undetermined.A review of the device history record was performed and no exception documents were identified.A review of the complaint database was performed and no similar complaints for this lot number were found.

• Brand Name: MERIT S-MAK¿.COAXIAL MINI ACCESS KIT.
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: bryson heaton bsn.rn ; 1600 merit pkwy; south jordan, UT 84095
• MDR Report Key: 17869366
• Report Number: 3011642792-2023-00060
• Device Sequence Number: 5493469
• Product Code: DRE
• UDI-Device Identifier: 00884450012635
• UDI-Public: 884450012635
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 03/13/2026
• Device Catalogue Number: S-MAK401N/C
• Device Lot Number: I2633581
• 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: 09/25/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACCESS NEEDLE
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown