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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC/ TELEFLEX MEDICAL VSI MICROINTRODUCER KIT INTRODUCER, CATHETER

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VASCULAR SOLUTIONS LLC/ TELEFLEX MEDICAL VSI MICROINTRODUCER KIT INTRODUCER, CATHETER Back to Search Results
Model Number IPN029495
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Tissue Damage (2104)
Event Date 12/23/2019
Event Type  Injury  
Event Description
Left heart cath procedure was aborted after sheath was dislodged from body after placement of a guidewire. The sheath required surgical removal and a right common femoral artery repair by vascular surgery. Patient was transferred to icu for stabilization and monitoring.
 
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Brand NameVSI MICROINTRODUCER KIT
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
VASCULAR SOLUTIONS LLC/ TELEFLEX MEDICAL
MDR Report Key9539941
MDR Text Key173655009
Report NumberMW5091988
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2022
Device Model NumberIPN029495
Device Catalogue Number7273V
Device Lot Number652666
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/31/2019 Patient Sequence Number: 1
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