MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. COAXIAL MINI ACCESS KIT; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/30/2020

Event Type  Injury  

Event Description

During right femoral puncture for emergent stroke intervention in (b)(6) year old man, the micro wire filament stretched and broke/fragmented which was left within right superficial femoral artery.Observed one degree with no movement or flow limitations-low risk for clinical consequence.Fda safety report id# (b)(4).

• Brand Name: COAXIAL MINI ACCESS KIT
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC. ; jordan UT 84095
• MDR Report Key: 10634644
• MDR Text Key: 210237086
• Report Number: MW5097097
• Device Sequence Number: 1
• Product Code: DRE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 94 YR
• Patient Weight: 61