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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC GUIDELINER CATHETER

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VASCULAR SOLUTIONS, INC GUIDELINER CATHETER Back to Search Results
Model Number 5569
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/13/2017
Event Type  Malfunction  
Manufacturer Narrative

There was no device returned for this event for evaluation, a conclusion for the failure could not be determined. The manufacturing records were reviewed and no nonconformances were related to this lot.

 
Event Description

5f guideliner was pulled and stent was loaded into the guideliner outside of the body an inserted into the guide catheter. Upon engaging the rca, the stent and guideliner were unable to advance into the mid rca, through multiple attempts to navigate the tortuosity, the stent was damaged and the stent struts were poking through the side of the guideliner, which was visualized upon removal of the guideliner. Stent and guideliner were removed safely from the body. No patient harm was caused. Additional information received: the stent struts did not poke through the guide catheter.

 
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Brand NameGUIDELINER
Type of DeviceCATHETER
Manufacturer (Section D)
VASCULAR SOLUTIONS, INC
6464 sycamore court north
minneapolis MN 55369
Manufacturer (Section G)
VASCULAR SOLUTIONS, INC
6464 sycamore court north
minneapolis MN 55369
Manufacturer Contact
mary haufek
6464 sycamore court north
minneapolis, MN 55369
7636564230
MDR Report Key7095456
MDR Text Key95072485
Report Number2134812-2017-00106
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK112082
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/13/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/07/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date08/29/2019
Device MODEL Number5569
Device LOT Number612691
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/13/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/29/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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