• 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 QUANTUM MAVERICK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, 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 QUANTUM MAVERICK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7010
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/10/2019
Event Type  malfunction  
Manufacturer Narrative
Returned product consisted of a quantum maverick balloon catheter. There was blood in the balloon. There were numerous hypotube kinks. The shaft was buckled throughout the distal shaft. Functional testing was performed by applying pressure with a water filled inflation device and found that water was leaking at the most proximal buckled location. Microscopic examination of the shaft revealed a hole in the outer shaft near the distal end of the core wire which indicates at some point the shaft buckled causing the core wire to puncture through the outer shaft.
 
Event Description
Reportable based on device analysis completed on 10jan2020. It was reported that a kink occurred. The 99% stenosed, 16mmx2. 75mm target lesion was located in the severely tortuous and calcified left main coronary artery. A 2. 75mm x 12mm quantum maverick balloon catheter was advanced for dilatation. However, the balloon delivery shaft was kinked. No patient complications were reported and the patient's status was stable. However, returned device analysis revealed a hole in the outer shaft.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameQUANTUM MAVERICK
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9643414
MDR Text Key178640461
Report Number2134265-2020-00689
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P860019
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 01/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/05/2022
Device Model Number7010
Device Catalogue Number7010
Device Lot Number0023744696
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/06/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-