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

Catalog Number	MAK405/D
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were identified.A search of the complaint database was performed and no similar complaints for this lot number were identified.
Event or Problem Description
The account alleges that the tip of an access wire dislodged within a patients vessel during access for hd catheter placement.The access wire detached and is currently wedged within the patient's adipose tissue.The physician is not concerned about possible iatrogenic foreign body [ifb] migration or embolism.There are no plans to remove the embedded ifb from this patient.The tip of the access wire is sterile encapsulate.

• Brand Name: MERIT MAK¿.COAXIAL MINI ACCESS KIT
• Common Device Name: DILATOR, VESSEL,
• 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 ; 1600 merit parkway; south jordan, UT 84095 ; 8012088662
• MDR Report Key: 19609853
• Report Number: 3011642792-2024-00034
• Device Sequence Number: 6359217
• Product Code: DRE
• UDI-Device Identifier: 00884450011454
• UDI-Public: 884450011454
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 06/10/2024

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: MAK405/D
• Device Lot Number: I2888833
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2024
• 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; ACCESS SHEATH
• Patient Sex: Unknown