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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
Device Problem Separation Problem (4043)
Patient Problem Insufficient Information (4580)
Event Date 02/22/2021
Event Type  malfunction  
Manufacturer Narrative
Manufacturing records will be reviewed.A follow-up report will be issued after the investigation is complete.
 
Event Description
As reported: during a physician presentation at session ix: complications of antegrade cto pci ((b)(6) 2021), a physician made reference to a turnpike with a tip separation that was left behind.Attempts were made for more information but it could not be provided.
 
Manufacturer Narrative
No product was returned to vsi for evaluation.No lot number was provided by the account.Therefore, a manufacturing record review could not be completed.Case details were reviewed.The event description states that a turnpike tip separation case was presented during a cto summit presentation.No product was returned to vsi/teleflex.A returned product evaluation was not completed.Additional information on the procedure was requested.No information was provided.Based on the limited information and no product evaluation, the most likely root cause on the type of damages either in the tip and/or shaft of the turnpike that could have occurred during the case is undeterminable.
 
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Brand Name
TURNPIKE SPIRAL
Type of Device
CATHETER
Manufacturer (Section D)
VASCULAR SOLUTIONS, LLC
6464 sycamore court north
minneapolis MN 55369
MDR Report Key11543807
MDR Text Key243124111
Report Number2134812-2021-00024
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K191560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received02/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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