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 38275
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/13/2022
Event Type  Injury  
Event Description
It was reported that the catheter tip detached.An imager ii angiographic 4f catheter was selected for use in a fistuloplasty.When the catheter was removed from the brachial artery, the tip detached.There was no resistance when the catheter was removed.Surgical intervention was required to open the vessel to remove the tip.The procedure had already been completed before the tip detached.The patient was stable and no further complications were reported.
 
Manufacturer Narrative
G1: mfr site state: (b)(6).Device eval by mfr: the returned product consisted of an imager ii catheter.25mm of tip was separated from the shaft.The separated ends appeared to be jagged as if the separation was do to tensile/ductile forces were applied.There were marks on the separated section which appeared to look like forceps imprints.A x-ray of the device was completed to see if there were any braids that were stretched.The reported tip separation was confirmed.
 
Event Description
It was reported that the catheter tip detached.An imager ii angiographic 4f catheter was selected for use in a fistuloplasty.When the catheter was removed from the brachial artery, the tip detached.There was no resistance when the catheter was removed.Surgical intervention was required to open the vessel to remove the tip.The procedure had already been completed before the tip detached.The patient was stable and no further complications were reported.
 
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
Manufacturer (Section G)
TELEFLEX MEDICAL
unit 7 8 and 9
annacotty
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key14003904
MDR Text Key288593035
Report Number2134265-2022-03843
Device Sequence Number1
Product Code DQO
UDI-Device Identifier08714729404439
UDI-Public08714729404439
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K120893
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/22/2022
Device Model Number38275
Device Catalogue Number38275
Device Lot Number0000154624
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
-
-