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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 Patient Device Interaction Problem (4001)
Patient Problem Atrial Fibrillation (1729)
Event Date 01/09/2021
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 study 30-day conducted on (b)(6) 2021 it was reported that 3 days post-procedure the patient suffered new onset of a-fib with rates to 120 bpm and frequent pvcs. This new onset of a-fib is probably attributed to the volume overload and myocardial manipulation performed during the index procedure performed on (b)(6) 2021 of a cto pci of the proximal rca in which a turnpike (study device), trapliner (study device), spectre guidewire (study device) and raider guidewire (study device) were used. Patient was treated with sync-cardioversion and medical management with amiodarone load. This event was resolved with no sequelae. Mdrs associated to: mdr 2134812-2021-00017 raider gw. Mdr 2134812-2021-00018 spectre gw. Mdr 2134812-2021-00019 trapliner.

 
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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 Key11457151
MDR Text Key246967824
Report Number2134812-2021-00020
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 02/10/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/10/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number5640
Device LOT Number678642
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 Received02/10/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 03/10/2021 Patient Sequence Number: 1
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