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

Catalog Number	MAK501N/B
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during access for a medical procedure, the tip of the access wire detached within the patient.The physician used a vascular snare device to successfully retrieve the foreign body from the patient.No additional patient consequences to report.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The device was examined visually, and functional testing was performed.The complaint is confirmed.The root cause could not be determined however, it is likely that significant force was applied to the device during clinical use.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.

• Brand Name: MERIT MAK
• Common Device Name: COAXIAL MINI ACCESS KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego, CA 92154
• MDR Report Key: 11335588
• Report Number: 3011642792-2021-00012
• Device Sequence Number: 3415880
• Product Code: DRE
• UDI-Device Identifier: 00884450028520
• UDI-Public: 884450028520
• Combination Product (Y/N): N
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: 11/25/2023
• Device Catalogue Number: MAK501N/B
• Device Lot Number: I1989575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACCESS NEEDLE.
• Outcome Attributed to Adverse Event: Required Intervention