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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXTERNAL MANUFACTURER ACUITY CATHETER; GUIDE CATHETER
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EXTERNAL MANUFACTURER ACUITY CATHETER; GUIDE CATHETER Back to Search Results
Model Number 8103
Device Problems Human-Device Interface Problem (2949); Material Integrity Problem (2978)
Patient Problems Cardiac Perforation (2513); Vascular Dissection (3160); Pericardial Effusion (3271)
Event Date 04/24/2018
Event Type  Injury  
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Event Description
Boston scientific received information that during an upgrade procedure this guide catheter was advanced into the vein, and when it was attempted to pass the guide wire though it was not possible to track down the target vein.Contrast was injected, but the target vein did not fill thus a dissection was suspected.The guide catheter was then moved to another smaller vein, but was unsuccessful when advancing.Another vein was then attempted to be engaged with the guide catheter, and after probing at the origin, the guide wire appeared to have suddenly advanced in the direction of the target vessel.It was however evident that the wire was not following the vessel path obtained in the initial venogram, and contrast confirmed a perforation of the coronary sinus.The procedure was then ended.The patient remained hemodynamically stable with minimal pericardial effusion while the existing device was put back into pocket.No additional adverse patient effects were reported.
 
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Brand Name
ACUITY CATHETER
Type of Device
GUIDE CATHETER
Manufacturer (Section D)
EXTERNAL MANUFACTURER
Manufacturer (Section G)
EXTERNAL MANUFACTURER
Manufacturer Contact
tim degroot
4100 hamline ave. n
st. paul, MN 
6515826168
MDR Report Key7566104
MDR Text Key109955554
Report Number2124215-2018-07813
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/16/2019
Device Model Number8103
Other Device ID NumberACUITY PRO INNER GUIDING CATHE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Manufacturer Received04/24/2018
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 Sequence Number1
Patient Outcome(s) Life Threatening;
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