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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GUIDEZILLA II CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION GUIDEZILLA II CATHETER, PERCUTANEOUS Back to Search Results
Model Number 1873
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Death (1802)
Event Date 08/27/2020
Event Type  Death  
Event Description

It was reported there was a patient death. The 80-90 % stenosed target lesion was located in the mildly calcified and mildly tortuous left anterior descending artery (lad). The concentrically shaped de novo target lesion was 32 mm long with a vessel diameter of 3. 5 mm. Vascular access was obtained from the right femoral artery. A 6f non-bsc guide catheter and non-bsc wire were used to cross the lad lesion. Predilation was performed with a 1. 5x12 non-bsc coronary dilatation catheter. Since the guide had poor support, the guide catheter was exchanged and further pre-dilatation was performed with a 2. 5 x 12 non-bsc coronary dilatation catheter. Following pre-dilatation, residual stenosis was 40% and the lesion yielded well. The 32 x 3. 50 promus premier stent was advanced for use, but there was difficulty due to the long lesion. A guidezilla guide extension catheter was used for support and the promus premier stent was deployed in the lad. There was no damage to the guidezilla guide extension catheter or promus premier stent. Post-dilation was performed. The patient complained about chest pain and final angioplasty was performed. A non-significant lesion in left circumflex artery (lcx) was observed. A plain old balloon angioplasty (poba) in the lcx was performed and the pain was relieved. The patient was shifted to the cardiac care unit (ccu). The result was good with a timi-3 flow. The patient complained of pain again and two hours later patient death occurred.

 
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Brand NameGUIDEZILLA II
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
two scimed place
maple grove 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10483674
MDR Text Key205332458
Report Number2134265-2020-12171
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK163314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 09/02/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/02/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1873
Device Catalogue Number1873
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 Received08/28/2020
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: 09/02/2020 Patient Sequence Number: 1
Treatment
ABBOTT - 1.5 X12 MINI TREK; ABBOTT - 2.5 X 12 TREK; ABBOTT - 3.75X12 NC TREK OTW; ASAHI - SION BLUE CATHETER GUIDEWIRE; MEDTRONIC - 6F CORONARY GUIDE CATHETER EBU 3.5
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