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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 8105
Device Problem Human-Device Interface Problem (2949)
Patient Problems Perforation (2001); No Consequences Or Impact To Patient (2199); Pericardial Effusion (3271)
Event Date 04/04/2016
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 while attempting to cannulate the coronary sinus with this catheter, the patient's pericardium was perforated.
 
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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
sonali vasekar
4100 hamline ave. n
st. paul, MN 
6515824786
MDR Report Key5816175
MDR Text Key50242224
Report Number2124215-2016-05526
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K132914
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 04/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/09/2017
Device Model Number8105
Other Device ID NumberACUITY PRO GUIDING CATHETER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 04/04/2016
Initial Date FDA Received07/22/2016
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) Hospitalization; Life Threatening; Required Intervention;
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