• 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 7580
Device Problems Inflation Problem (1310); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/07/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Device evaluated by mfr. : returned product consisted of a maverick 2 balloon catheter. The hypotube was fractured 48cm from hub, the fractured ends were ovaled indicating that the hypotube was kinked prior to fracturing. There were numerous kinks throughout the hypotube. The balloon was inflated by connecting a toughy and stopcock to the fractured end and pressurizing with an inflation device. The balloon maintained pressure for 5 minutes and there were no leaks observed.
 
Event Description
Reportable based on device analysis completed on 30dec2019. It was reported that shaft kink and inflation failure occurred. Vascular access was obtained via femoral artery. The target lesion was located in the severely tortuous and mildly calcified left circumflex coronary artery. A 2. 00mm x 12mm maverick balloon catheter was advanced for dilatation, but the shaft was kinked and the balloon could not inflate properly. The procedure was completed with a non-bsc balloon catheter. No patient complications were reported and the patient's status was stable. However, returned device analysis revealed shaft separation.
 
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 Key9590435
MDR Text Key178032512
Report Number2134265-2019-16796
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIN
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 01/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7580
Device Catalogue Number7580
Device Lot Number0023938972
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-