MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MERIT MAK COAXIAL MINI ACCESS KIT

Catalog Number	MAK505-E/A
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a diagnostic cerebral angiogram procedure, resistance was felt while attempting right femoral artery access.When attempting to remove the access guidewire, the tip of the guidewire was sheared off and was embedded within the subcutaneous tissue of the patient.

• Brand Name: MERIT MAK COAXIAL MINI ACCESS KIT
• Common Device Name: ACCESS KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva road #100; san diego CA 92154
• MDR Report Key: 9528651
• Report Number: 3011642792-2019-00029
• Device Sequence Number: 17009668
• Product Code: DRE
• UDI-Device Identifier: 00884450012604
• UDI-Public: 00884450012604
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K031691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2019

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 Expiration Date: 06/30/2022
• Device Catalogue Number: MAK505-E/A
• Device Lot Number: 11609263
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 12/29/2019
• Supplement Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1