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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 Problems Kinked (1339); Compatibility Problem (2960)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/21/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Device evaluated by mfr: the returned product consisted of a guidezilla guide extension catheter.The device was bloody.The hypotube, collar, distal shaft and tip were microscopically and tactile inspected.Inspection revealed tip damage (misshapen/abrasions) with part of the shaft material scrapped off of the markerband, shaft damage (abrasions) and numerous kinks in the distal shaft.The inner diameter (id) of the tip could not be measured due to the damage to the tip, however; the collar id was measured (with a calibrated pin gage) and found to meet guidezilla specifications.Functional testing was carried out by loading a lab supplied stented catheter into the collar of the device.The stented catheter advanced for 5.5 cm, and then stopped advancing at the location of a significant kink in the guidezilla.The damage to the device is consistent with complicated anatomy.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
 
Event Description
Reportable based on device analysis completed on 3-may-2018.It was reported that there was difficulty advancing another device through this catheter due to a device kink.A guidezilla¿ device was selected for use during a percutaneous coronary intervention.The target lesion was located at the mid left circumflex artery (lcx).The physician used a non-bsc device for femoral access.The lesion was predilated using an emerge 2.50 x 15 balloon and later with an emerge 3.50 x 15.The physician then tried to advance a synergy 4.00 x 24 but it could not be delivered to the target lesion.The physician then removed the stent and inserted a guidezilla to help deliver the stent to the target lesion, but the stent could not be advanced through the guidezilla.Upon removal, it was noticed that the guidezilla was kinked.The physician then proceeded to balloon and prepare the lesion further including the bend before the lesion.Finally the physician successfully delivered the same synergy 4.00 x 24 stent to the target lesion.The case was completed after post dilating the stent with nc emerge 4.50 x 12 and 5.00 x 12 devices.No patient complications were reported.The patient's condition after the procedure was stable.However, device analysis revealed that a part of the shaft material was scrapped off of the markerband.
 
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Brand Name
GUIDEZILLA¿
Type of Device
CATHETER, 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 Key7541766
MDR Text Key109187912
Report Number2134265-2018-04533
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K123765
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 05/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/17/2019
Device Model NumberH7493924215050
Device Catalogue Number39242-1505
Device Lot Number21269184
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/03/2018
Initial Date FDA Received05/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
HEARTRAIL 6F BL3.0 GUIDER -FEMORAL ACCESS
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