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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 Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/16/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that radiopaque markers deformation occurred. The target lesion was located in the coronary artery. A guidezilla¿ guide extension catheter was selected for use. During preparation, it was noted that the catheter radiopaque marker banks became deformed 4cm away from the tip. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable.

 
Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis. The shaft and tip were microscopically examined. There was blood on the outside of the device. Majority of the shaft was flattened and kinked. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. No other issues were identified during the product analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is considered handling damage as the event occurred without direct patient contact. (b)(4).

 
Event Description

It was reported that radiopaque markers deformation occurred. The target lesion was located in the coronary artery. A guidezilla guide extension catheter was selected for use. During preparation, it was noted that the catheter radiopaque marker banks became deformed 4cm away from the tip. The procedure was completed with another of the same device. No patient complications were reported and the 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 Key6619213
MDR Text Key76965694
Report Number2134265-2017-05498
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,Followup
Report Date 05/17/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/07/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2018
Device MODEL NumberH7493924215050
Device Catalogue Number39242-1505
Device LOT Number20055373
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/22/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/28/2016
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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