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 INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
  • 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 INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number 83779
Device Problems Break (1069); Premature Activation (1484)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2022
Event Type  malfunction  
Event Description
It was reported that coil fibers detached in the sheath.The target lesion was located in the pulmonary artery fistula.A 3mm x 6cm pe f-idc interlock was selected for use.During the procedure, it was noted that this device was advanced and deployed prematurely in the microcatheter.Upon withdrawal of the coil some of the fibers had collected in the sheath.The procedure was completed with another of the same device.No complications reported and the patient is fine.
 
Event Description
It was reported that coil fibers detached in the sheath.The target lesion was located in the pulmonary artery fistula.A 3mm x 6cm pe f-idc interlock was selected for use.During the procedure, it was noted that this device was advanced and deployed prematurely in the microcatheter.Upon withdrawal of the coil some of the fibers had collected in the sheath.The procedure was completed with another of the same device.No complications reported and the patient is fine.
 
Manufacturer Narrative
Device evaluated by manufacturer: only the main coil was returned for product analysis, and it was found in good conditions.Since only the main coil was received the functional inspection could not be performed.Dimensional inspections revealed that the overall dimension of the coil arm, zap tip and primary coil were within the specification.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INTERLOCK
Type of Device
DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
model farm road
cork
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key16109414
MDR Text Key307303368
Report Number2124215-2022-54928
Device Sequence Number1
Product Code KRD
UDI-Device Identifier08714729764939
UDI-Public08714729764939
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K132578
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number83779
Device Catalogue Number83779
Device Lot Number0029719918
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/31/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/07/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age65 YR
Patient SexMale
-
-