MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO MERIT MAK-NV.COAXIAL MINI ACCESS KIT; NON-VASCULAR CATHETER INTRODUCTION SET

Catalog Number	MAK-NV-010/A
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is 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 drain installation technique by micro-puncture using the seldinger technique, the blunt end of the micro-guide ruptured and has remained in the patient.No additional patient consequence to report.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed and the root cause is attributed to clinical use and excessive force during use.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.

• Brand Name: MERIT MAK-NV.COAXIAL MINI ACCESS KIT
• Common Device Name: NON-VASCULAR CATHETER INTRODUCTION SET
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• MDR Report Key: 12134879
• Report Number: 3011642792-2021-00015
• Device Sequence Number: 11717571
• Product Code: GCB
• UDI-Device Identifier: 00884450088807
• UDI-Public: 884450088807
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: 12/31/2022
• Device Catalogue Number: MAK-NV-010/A
• Device Lot Number: I1733651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention