• 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 08/30/2018
Event Type  Malfunction  
Manufacturer Narrative

Age at the time of event: over 65 years old.

 
Event Description

It was reported that device sheared off the balloon. The target lesion was located in the calcified and tortuous circumflex artery. A 3. 50 x 28mm synergy stent was advanced but failed to cross due to tortuosity. A 6f guidezilla ii guide extension catheter was then advanced for support. However, when the device was advanced out of the guidezilla towards the lesion, the stent came in contact with the distal tip of the guidezilla and sheared off the balloon. An emerge balloon was inflated to pin the stent in place. Bifemoral access was stuck and a second 7f non-bsc guide catheter was used with a gooseneck snare. The snare captured the end of the stent floating in the aorta, and the inflated balloon pinning the stent was deflated after the gooseneck captured the stent. The stent was pulled through the non-bsc guide catheter and out of the body. A 3. 0 x 15mm nc quantum apex was advanced for dilatation and the procedure was completed with a 3. 5x28mm synergy stent. No patient complications were reported and the patient's status was fine.

 
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 MN 55311
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key7909675
MDR Text Key121725159
Report Number2134265-2018-61281
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK163314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 09/26/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/26/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/15/2020
Device MODEL Number1871
Device Catalogue Number1871
Device LOT Number0021995037
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 Received08/30/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/16/2018
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: 09/26/2018 Patient Sequence Number: 1
Treatment
BALLOON STENT: SYNERGY
-
-