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 MAMBA; MAMBA MICROCATHETER
  • 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 MAMBA; MAMBA MICROCATHETER Back to Search Results
Model Number 8577
Device Problem Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2023
Event Type  malfunction  
Event Description
It reported that removal difficulties occurred.A 135cm mamba flex microcatheter was selected for use.The distal part of the microcatheter could not be removed from the 0.014 guidewire.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
B3: date of event: it was not provided, used the first date of the month of the aware date.
 
Manufacturer Narrative
B3: date of event: it was not provided, used the first date of the month of the aware date.Device evaluated by manufacture: returned product consisted of a mamba flex microcatheter.The hub, shaft and tip were visually and microscopically examined.The device showed no damage.The reported complaint was issued for obstruction in the lumen.The device was flushed with a syringe of fluid and the fluid did not come out of the tip end.A.014 test guidewire was inserted into the hub end of the device and the wire transcended through the device without hesitations and restrictions in the lumen but failed to exit the tip.The tip was inspected and found a piece of foreign material (fm) in the tip.Alpha-hydroxyalprazolam (ahal) testing was performed on the returned device to identify the fm.The material was found to most closely resemble polymethyl methacrylate (pmma).Pmma is a known component of medical adhesive used during procedures.
 
Event Description
It reported that removal difficulties occurred.A 135cm mamba flex microcatheter was selected for use.The distal part of the microcatheter could not be removed from the 0.014 guidewire.The procedure was completed with another of the same device.No patient complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MAMBA
Type of Device
MAMBA MICROCATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
model farm road
cork T12 Y K88
EI   T12 YK88
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17588278
MDR Text Key321647455
Report Number2124215-2023-44754
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8577
Device Catalogue Number8577
Device Lot Number0029602992
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/08/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-