• 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 7005
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 03/26/2020
Event Type  malfunction  
Event Description
It was reported that shaft break occurred. A 3. 0mm x 8mm quantum maverick balloon catheter was unpacked, however; the balloon was fractured. The procedure was completed with another of the same device. This was not used inside the patient's body.
 
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 Key10115638
MDR Text Key193733089
Report Number2134265-2020-06550
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729392569
UDI-Public08714729392569
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,Followup
Report Date 07/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/08/2022
Device Model Number7005
Device Catalogue Number7005
Device Lot Number0024395604
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-