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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION GUIDEZILLA CATHETER, PERCUTANEOUS Back to Search Results
Model Number 1867
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/24/2018
Event Type  malfunction  
Manufacturer Narrative
Event date: event date was approximated based on reported information and aware date.
 
Event Description
It was reported that the guide extension catheter damaged another device. A 4. 00x38mm synergy ii drug-eluting stent was advanced for treatment. However, it was noted that the stent became stuck in the guidezilla extension guide catheter. When the device was pulled out, it came off the stent delivery system. The dislodged stent was retrieved and another 4. 0x38mm stent was used to complete the procedure. No patient complications were reported and the patient's status was okay.
 
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Brand NameGUIDEZILLA
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 MN 55311
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8073684
MDR Text Key127346369
Report Number2134265-2018-62926
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123765
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 11/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1867
Device Catalogue Number1867
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 Received10/24/2018
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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