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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NAVILYST MEDICAL INC. / ANGIO DYNAMICS, INC. MINI STICK MAX - COAXIAL MICROINTRODUCER KIT N/A UNK; WIRE, GUIDE, CATHETER
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NAVILYST MEDICAL INC. / ANGIO DYNAMICS, INC. MINI STICK MAX - COAXIAL MICROINTRODUCER KIT N/A UNK; WIRE, GUIDE, CATHETER Back to Search Results
Model Number H965457500
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/07/2018
Event Type  Injury  
Event Description
During a groshong catheter placement; a mini stick max/ coaxial microintroducer kit made by (b)(4) was used.A portion of the introducer sheath broke off during withdrawal over a 0.035 wire.The portion retained was 8.3 cm as evidenced by the remaining 1.7 cm sheath that was attached to the orange hub.The retained portion was located in the right atrium.Confirmed by cat scan.Date of use: (b)(6) 2018; diagnosis or reason for use: long term antibiotic use; is the product compounded? no.Is the product over-the-counter? no.
 
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Brand Name
MINI STICK MAX - COAXIAL MICROINTRODUCER KIT N/A UNK
Type of Device
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
NAVILYST MEDICAL INC. / ANGIO DYNAMICS, INC.
marlborough MA 01752
MDR Report Key8194420
MDR Text Key131641774
Report NumberMW5082549
Device Sequence Number1
Product Code DQX
UDI-Device IdentifierH965457500
UDI-PublicH965457500
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/20/2018
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
Device Operator Health Professional
Device Model NumberH965457500
Device Catalogue Number45-750
Device Lot Number5396570
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/21/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
Patient Weight59
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