• 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 CORPORATION GUIDEZILLA II 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 CORPORATION GUIDEZILLA II CATHETER, PERCUTANEOUS Back to Search Results
Model Number 1871
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/14/2020
Event Type  Malfunction  
Event Description

It was reported that the guidezilla dislodged the original synergy stent and had to be snared. The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified diagonal of left anterior descending artery. A guidezilla ii catheter guide extension and a synergy drug-eluting stent were selected for use. During procedure, the stent would not advance further into the lesion so the doctor took the guidezilla 6f. The guidezilla was inserted into the proximal part of the stent and they tried to advance it further into the lesion, however resistance was felt. The guidezilla and stent were removed together and it was noted that the stent was not attached to the delivery system. It was noticed that the stent was partially unraveled and distorted. A snaring device was used to remove the stent out. The procedure was completed with another synergy stent. No patient complications were reported.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGUIDEZILLA II
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 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10734118
MDR Text Key213018259
Report Number2134265-2020-14724
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK163314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/26/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1871
Device Catalogue Number1871
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 Received10/21/2020
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

Patient TREATMENT DATA
Date Received: 10/26/2020 Patient Sequence Number: 1
Treatment
STENT BALLOON EXPANDABLE: SYNERGY
-
-