Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Break (1069); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/31/2021
Event Type  malfunction  
Event Description
It was reported that a shaft break occurred.A 3.00mm x 20mm maverick balloon was introduced inside the catheter, but the device kinked and broke.The broken end was observed to be outside of the catheter, and the device was removed without problems.The procedure was successfully completed with another of the same device.No patient complications were reported in relation to this event.
 
Event Description
It was reported that a shaft break occurred.A 3.00mm x 20mm maverick balloon was introduced inside the catheter, but the device kinked and broke.The broken end was observed to be outside of the catheter, and the device was removed without problems.The procedure was successfully completed with another of the same device.No patient complications were reported in relation to this event.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a maverick 2 mr balloon catheter.The device was microscopically and visually examined.The hypotube of the device has numerous kinks.There was a separation 57.7cm from the strain relief.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported events as there was separation to the hypotube and the device had numerous kinks.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MAVERICK
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11939354
MDR Text Key254281261
Report Number2134265-2021-07247
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729370208
UDI-Public08714729370208
Combination Product (y/n)N
PMA/PMN Number
P860019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/12/2023
Device Model Number7590
Device Catalogue Number7590
Device Lot Number0025203366
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2021
Date Manufacturer Received06/29/2021
Patient Sequence Number1
-
-