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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 Problems Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/26/2018
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a guidezilla guide extension catheter. The hypotube, collar, distal shaft and tip was microscopically and visually inspected. Inspection revealed a partial separation at the collar and tip damage (misshapen). The damage to the tip is likely attributed to being used in a procedure and with a guide wire. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
 
Event Description
Reportable based on device analysis completed on 13-dec-2018. It was reported that the guidezilla was broken proximal to the hypotube transition zone near the hub. A guidezilla guide extension catheter was selected for use. During the procedure, it was noted that the catheter was broken proximal to the hypotube transition zone 0. 5 cm from the hub. Furthermore, two non bsc stents broke because of the guidezilla. The procedure was completed with a different device. No patient complications were reported and the patient's status was stable. However, device analysis revealed a partial separation at the collar.
 
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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 Key8215136
MDR Text Key132046491
Report Number2134265-2018-64702
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeHU
PMA/PMN Number
K123765
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 01/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/11/2020
Device Model Number1867
Device Catalogue Number1867
Device Lot Number0022239931
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2018
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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