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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC TURNPIKE SMOOTH CATHETER

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VASCULAR SOLUTIONS, LLC TURNPIKE SMOOTH CATHETER Back to Search Results
Model Number 5642
Device Problem Separation Problem (4043)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/04/2021
Event Type  Injury  
Manufacturer Narrative

Manufacturing records will be reviewed. A follow-up report will be issued after the investigation is complete.

 
Event Description

As reported: during the pci procedure on it was found that a small portion of the distal tip of the turnpike catheter was dislodged and left inside the vessel of the patient. It was reported that the patient condition is stable. Reported that there is no medical intervention to remove the tip.

 
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Brand NameTURNPIKE SMOOTH
Type of DeviceCATHETER
Manufacturer (Section D)
VASCULAR SOLUTIONS, LLC
6464 sycamore court north
minneapolis MN 55369
Manufacturer (Section G)
VASCULAR SOLUTIONS, LLC
6464 sycamore court north
minneapolis MN 55369
Manufacturer Contact
mary haufek
6464 sycamore court north
minneapolis, MN 55369
7636564300
MDR Report Key11591078
MDR Text Key243127901
Report Number2134812-2021-00025
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeHK
PMA/PMN NumberK191560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/05/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/30/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5642
Device LOT Number676819
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/14/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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