• 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 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 MAVERICK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7590
Device Problems Material Rupture (1546); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2021
Event Type  malfunction  
Event Description
It was reported that balloon burst occurred. The 85% stenosed target lesion was located in the severely tortuous and severely calcified mid left anterior descending artery. A 2. 50mm x 20mm maverick balloon catheter was advanced for dilation. However, during second inflation at 12 atmospheres for 21-22 seconds, the balloon burst and the shaft was kinked. There were no balloon pieces left in the patient's body. The procedure was completed with another of same device. There were no patient complications nor injuries reported and the patient's status was stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMAVERICK
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 Key12675527
MDR Text Key277966491
Report Number2134265-2021-13291
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
P860019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7590
Device Catalogue Number7590
Device Lot Number0027381652
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/25/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-