• 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 STINGRAY 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 STINGRAY CATHETER, PERCUTANEOUS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Myocardial Infarction (1969); Perforation (2001); Cardiac Tamponade (2226); Vascular Dissection (3160)
Event Date 10/12/2018
Event Type  Injury  
Manufacturer Narrative

Zivelonghi, c, van kuijk, j. P. , et al (2019). A "minimalistic hybrid algorithm" in coronary chronic total occlusion revascularization: procedural and clinical outcomes. Catheter cardiovasc interv. Volume 95, pages 97-104. : date of event was approximated using date of article submission.

 
Event Description

It was reported via journal article that serious injuries occurred. Percutaneous recanalization of coronary chronic total occlusions (ctos) data was reviewed for various techniques. In some approaches, stingray and crossboss devices were used. Two perforations were observed, one of which resulting in cardiac tamponade and requiring pericardiocentesis after successful recanalization of a mid-right coronary artery (rca), the other involving a septal branch and treated conservatively by balloon inflation in place and protamine administration with no hemodynamic consequences, after failed septo-septal ipsilateral crossing in a mid-left anterior descending artery (lad) occlusion. Of note, two donor-artery dissections, were observed during the procedure and treated with stent implantation. Three myocardial infarctions were also noted. At clinical follow-up, one myocardial infarction and three target vessel revascularizations were noted.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTINGRAY
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10119681
MDR Text Key194024785
Report Number2134265-2020-07532
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeNL
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 06/04/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/04/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received05/26/2020
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?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/04/2020 Patient Sequence Number: 1
-
-