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U.S. Department of Health and Human Services

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

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VASCULAR SOLUTIONS, LLC TURNPIKE SPIRAL CATHETER Back to Search Results
Model Number 5640
Device Problem Separation Problem (4043)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/12/2021
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: physician used a turnpike spiral and during the procedure a piece of the black tip separated from the end and was in the left main. They were unable to retrieve using a snare, so they placed a stent in the left main to keep the piece of the tip in place against the wall of the artery.

 
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Brand NameTURNPIKE SPIRAL
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 Key11638248
MDR Text Key246969983
Report Number2134812-2021-00027
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK191560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/15/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5640
Device LOT Number704744
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 Received03/15/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/22/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/08/2021 Patient Sequence Number: 1
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