• 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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Cardiogenic Shock (2262)
Event Date 03/07/2018
Event Type  Death  
Manufacturer Narrative
Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).
 
Event Description
Same case as mdr id #: 2134265-2018-02588, 2134265-2018-02589, 2134265-2018-02590, 2134265-2018-02591, 2134265-2018-02592, 2134265-2018-02593, 2134265-2018-02628, 2134265-2018-03162, 2134265-2018-03163, 2134265-2018-03164, 2134265-2018-03165, 2134265-2018-03166, 2134265-2018-03167, 2134265-2018-03168, 2134265-2018-03173. It was reported that the patient died post procedure. The patient presented from hospice care. The patient was intubated and had a non-bsc heart pump in place. The target lesions were a chronic total occlusion of the right coronary artery (rca), the left anterior descending artery (lad) and the severely tortuous circumflex. Seventeen boston scientific products were used throughout the procedure. The physician started with the circumflex and experienced a vessel perforation caused by a non-bsc guidewire. The perforation was minimal and was not treated. The lad and left main arteries were successfully stented with 2. 50x38mm, 3. 00x38mm and 3. 50x16mm synergy stents and balloon angioplasty was performed. At that point, the patient¿s pressure and heart rate were both dropping. The heart rate was increased with pacing and the procedure was ended. The patient was sent from the catheterization lab to the floor where he expired some hours later during the night. The cause of death is cardiogenic shock.
 
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 Key7383724
MDR Text Key103909005
Report Number2134265-2018-03169
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163314
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 03/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberH7493933515060
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 Received03/07/2018
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

Patient Treatment Data
Date Received: 03/29/2018 Patient Sequence Number: 1
-
-