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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE GUIDEZILLA¿ CATHETER, PERCUTANEOUS Back to Search Results
Model Number H7493924215050
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2018
Event Type  Malfunction  
Manufacturer Narrative

Device evaluated by mfr. : it is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).

 
Event Description

Same case as mdr id: 2134265-2018-05931. It was reported that the shaft broke upon removal from the guidezilla. The 90% stenosed, 38mm in length target lesion was located in the seriously tortuous, calcified and 3. 5mm in diameter left anterior descending artery. Pre-dilatation was performed using a 2. 5x12mm quantum maverick and a 3x15mm balloon catheter but the mid part of the lesion was not inflated. The physician then used a rotablator to expand the lesion at a speed of 180000 revolutions per minute. A 3. 50 x 38mm synergy¿ drug-eluting stent was then advanced with a guidezilla guide catheter extension as a support. However, during withdrawal, the shaft was fractured and the broken part could not be removed. The patient was then sent to surgery for the removal of the broken fragment. No further patient complications were reported and patient's status was stable.

 
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Brand NameGUIDEZILLA¿
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 Key7677900
MDR Text Key113757705
Report Number2134265-2018-06428
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCN
PMA/PMN NumberK123765
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 06/21/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/11/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH7493924215050
Device Catalogue Number39242-1505
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 Received06/21/2018
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

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