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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE GUIDEZILLA¿ II GUIDE EXTENSION CATHETER CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE GUIDEZILLA¿ II GUIDE EXTENSION CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number UNK963
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intimal Dissection (1333); Death (1802)
Event Date 06/08/2017
Event Type  Death  
Manufacturer Narrative

Device evaluated by manufacturer: the device was not returned for evaluation. The batch number is unknown and the manufacturing records for the complaint device could not be reviewed. The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu. (b)(4).

 
Event Description

It was reported that a patient vessel dissection and subsequent death occurred. The long disease segment target lesion was located in the not overly calcified left anterior descending (lad) artery. A guidezilla¿ ii guide extension catheter was used to deliver a stent to the target lesion. The stent was deployed successfully and the guidezilla¿ ii was removed. At this time the physician noted some staining around the ostium of the left main. The proximal ostial left main into the aorta was severely dissected. A stent was placed in the left main to treat the dissection; however, the patient expired on the table.

 
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Brand NameGUIDEZILLA¿ II GUIDE EXTENSION CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6680850
MDR Text Key78817785
Report Number2134265-2017-06404
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK163314
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 06/09/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNK963
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 Received06/09/2017
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

Patient TREATMENT DATA
Date Received: 06/30/2017 Patient Sequence Number: 1
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