Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 1873
Device Problems Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/04/2021
Event Type  malfunction  
Event Description
It was reported that collar separation occurred.A percutaneous coronary intervention-st-elevation myocardial infarction procedure was being performed.The target lesion was located in the mid right coronary artery.A 6f long guidezilla ii catheter guide extension was inserted over a 180cm runthrough wire.The guidezilla was advanced but was met with resistance.A 2.50 x 20 emerge mr balloon catheter was inserted to help advance the guidewire and was partially successful.A 4.0 x 32 synerg xd drug-eluting stent was delivered but was unsuccessful.Subsequently, two 4.0 x 20 synergy xd drug-eluting stents were advanced but failed to deliver due to increased resistance.The guidezilla was removed and the physician noticed that the device was deformed and there was some separation from the collar.The procedure was completed with a non-bsc product.There were no patient complications nor injuries reported.
 
Manufacturer Narrative
B5 - updated event description.
 
Event Description
It was reported that collar separation occurred.A percutaneous coronary intervention-st-elevation myocardial infarction procedure was being performed.The target lesion was located in the mid right coronary artery.A 6f long guidezilla ii catheter guide extension was inserted over a 180cm runthrough wire.The guidezilla was advanced but was met with resistance.A 2.50 x 20 emerge mr balloon catheter was inserted to help advance the guidewire and was partially successful.A 4.0 x 32 synerg xd drug-eluting stent was delivered but was unsuccessful.Subsequently, two 4.0 x 20 synergy xd drug-eluting stents were advanced but failed to deliver due to increased resistance.The guidezilla was removed and the physician noticed that the device was deformed and there was some separation from the collar.The procedure was completed with a non-bsc product.There were no patient complications nor injuries reported.It was further reported that the target lesion was 75-80% stenosed, mildly tortuous, mildly calcified, and with no severe angulation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GUIDEZILLA II
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12012021
MDR Text Key256714456
Report Number2134265-2021-07767
Device Sequence Number1
Product Code DQY
UDI-Device Identifier08714729939467
UDI-Public08714729939467
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 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/19/2022
Device Model Number1873
Device Catalogue Number1873
Device Lot Number0026654904
Was Device Available for Evaluation? No
Date Manufacturer Received06/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-