• 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 04/28/2019
Event Type  malfunction  
Manufacturer Narrative
Returned product consisted of a quantum maverick balloon catheter. The shaft, hypotube, tip and balloon were microscopically and visually examined. There were numerous kinks. There was a complete separation at 58. 7cm distal of the strain relief. There was blood in the guidewire lumen. The balloon was tightly folded. Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
Reportable based on device analysis completed on 08jul2019. It was reported that shaft kink occurred. A 3. 25mm x 12mm quantum maverick balloon catheter was advanced for dilatation. However, it was noted that the delivery sheath was kinked. The procedure was completed with another of the same device. There were no patient complications nor injuries reported and the patient's status was stable. However, returned device analysis revealed shaft was separated.
 
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 SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key8837800
MDR Text Key152537114
Report Number2134265-2019-08906
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,distri
Reporter Occupation
Type of Report Initial
Report Date 07/29/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/03/2022
Device Model Number7010
Device Catalogue Number7010
Device Lot Number0023138202
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/04/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-