• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC - MAPLE GROVE GUIDEZILLA¿ II GUIDE EXTENSION CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number H7493933515060
Device Problems Failure to Advance (2524); Device Damaged by Another Device (2915); Material Deformation (2976); Catheter (3038)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2017
Event Type  Malfunction  
Manufacturer Narrative

Age at the time of event: 18 years or older. (b)(4). Returned product consisted of a guidezilla guide extension catheter. The device was bloody. The hypotube, collar, distal shaft and tip was microscopically and tactile inspected. Inspection revealed numerous kinks in the hypotube, a partial separation at the collar, a kink in the distal shaft located at 18cm and 19. 5 cm from the tip, and tip damage (ptfe separating/stretched). 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 21dec2017. It was reported that the device was unable to cross the lesion, the device damaged a stent and the device was deformed. A guidezilla¿ ii guide extension catheter was selected for a percutaneous coronary intervention (pci) procedure in the left circumflex coronary artery (lcx) proximal. During the procedure, the guidezilla was unable to cross the lesion but was placed in the left main trunk (lmt). A non-bsc stent was advanced and was unable to cross the lesion. It was noted that the non bsc stent was lifted up. There were a few deformations observed at the entrance part of the guidezilla so the deice was removed and the procedure was completed with a different device. There were no patient complications reported. However, device analysis revealed a partial separation at the collar.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGUIDEZILLA¿ II GUIDE EXTENSION CATHETER
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 Key7200477
MDR Text Key97896269
Report Number2134265-2017-13150
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
PMA/PMN NumberK163314
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 12/21/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/17/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/22/2019
Device MODEL NumberH7493933515060
Device LOT Number20802030
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/05/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/23/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-