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 IMAGER II ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC
  • 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 IMAGER II ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 38270
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/17/2020
Event Type  Injury  
Event Description
It was reported that tip detachment occurred.A 5fr imager ii angiographic catheter was selected for a uterine artery embolization procedure.A femoral approach was used to access the mildly calcified eccentrically shaped lesion.The anatomy was not tortuous.During the procedure, approximately 3-5cm of the tip of the catheter detached inside the patient and was visible on fluoroscopy.The tip was retrieved using a snare.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
IMAGER II ANGIOGRAPHIC CATHETER
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11003788
MDR Text Key221473187
Report Number2134265-2020-17438
Device Sequence Number1
Product Code DQO
UDI-Device Identifier08714729354963
UDI-Public08714729354963
Combination Product (y/n)N
PMA/PMN Number
K121694
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Remedial Action Recall
Type of Report Initial
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/27/2021
Device Model Number38270
Device Catalogue Number38270
Device Lot Number0000144528
Was Device Available for Evaluation? No
Date Manufacturer Received11/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number92484513-FA
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age41 YR
Patient Weight68
-
-