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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 Perforation (2001)
Event Date 12/18/2020
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

As reported: physician was working in a cto of a severly calcified rca and reported the turnpike spiral catheter was turned 20-30 times when the physician noticed the tip started to separate. The catheter was removed from the patient and a atherectomy device was used, a perforation was noted. A stent was placed and the outcome of patient was stable.

 
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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 Key11142235
MDR Text Key226011453
Report Number2134812-2021-00003
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK191560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/18/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5640
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/08/2021 Patient Sequence Number: 1
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