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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number 83786
Device Problems Premature Activation (1484); Malposition of Device (2616)
Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2023
Event Type  Injury  
Event Description
It was reported that coil migration occurred.The target lesion was located in the right gonadal vein.A 15mm x 40cm interlock-35 was selected for use.During the procedure, the coil was not coupled and the device was released prematurely.Consequently, it was noted that the coil was in the wrong location.The procedure was not completed as intended, and the procedure was cancelled.The patient was then admitted to another hospital to retrofit the coil that was in the wrong location.
 
Event Description
It was reported that coil migration occurred.The target lesion was located in the right gonadal vein.A 15mm x 40cm interlock-35 was selected for use.During the procedure, the coil was not coupled and the device was released prematurely.Consequently, it was noted that the coil was in the wrong location.The procedure was not completed as intended, and the procedure was cancelled.The patient was then admitted to another hospital to retrofit the coil that was in the wrong location.
 
Manufacturer Narrative
F10- patient and impact codes updated.
 
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Brand Name
INTERLOCK-35
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
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16576718
MDR Text Key311654449
Report Number2124215-2023-10621
Device Sequence Number1
Product Code KRD
UDI-Device Identifier08714729793144
UDI-Public08714729793144
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K133208
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 04/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number83786
Device Catalogue Number83786
Device Lot Number0029846351
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/23/2023
Initial Date FDA Received03/20/2023
Supplement Dates Manufacturer Received03/28/2023
Supplement Dates FDA Received04/25/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/28/2022
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 Outcome(s) Hospitalization;
Patient Age53 YR
Patient SexFemale
Patient Weight74 KG
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