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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE GUIDEZILLA¿ II LONG GUIDE EXTENSION CATHETER CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE GUIDEZILLA¿ II LONG GUIDE EXTENSION CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number H74939335150610
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/24/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Same case as mdr id: 2134265-2018-05620. It was reported that interaction with another device during withdrawal occurred. The target lesion was located in a coronary artery. A 6f guidezilla¿ ii long guide extension catheter was in use while a 3. 50 x 32 synergy ii drug-eluting stent was advanced for treatment. When the physician attempted to remove the stent, it was snagged by the guidezilla¿ and became unusable. No patient complications were reported and the patient's status was fine.
 
Event Description
Same case as mdr id: 2134265-2018-05620. It was reported that interaction with another device during withdrawal occurred. The target lesion was located in a coronary artery. A 6f guidezilla ii long guide extension catheter was in use while a 3. 50 x 32 synergy ii drug-eluting stent was advanced for treatment. When the physician attempted to remove the stent, it was snagged by the guidezilla and became unusable. No patient complications were reported and the patient's status was fine.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis. Returned product consisted of a 6f long guidezilla 2 guide extension catheter. The hypotube, collar, distal shaft and tip was microscopically and tactile inspected. Inspection revealed tip damage (markerband slightly flattened/abrasion on markerband area), distal shaft damage (shaft flattened near markerband area) and collar damage. The collar was damaged at the apex of the collar opening (extruded collar material), that is consistent with being snagged on a stent strut. The distal tip was measured and met specification. The collar could not be accurately be measured due to the found collar damage. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event. (b)(4).
 
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Brand NameGUIDEZILLA¿ II LONG GUIDE EXTENSION CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
MDR Report Key7631023
MDR Text Key112293613
Report Number2134265-2018-05633
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K163314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/02/2020
Device Model NumberH74939335150610
Device Lot Number22078171
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2018
Is This a Reprocessed and Reused Single-Use Device? No

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