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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 83787
Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2022
Event Type  malfunction  
Event Description
It was reported that the coil has come out of the catheter.The target lesion was located in the moderately tortuous and non-calcified internal iliac artery.A 8mm x 20cm.035 interlock cube embolics was selected for use.During delivery of the product, a gutter was created by breaking through the wall of the catheter instead of the tip and the coil has come out of the catheter.The entire catheter was removed, however, two-thirds of the coil protruded from the tip.The procedure was completed with a different device.There were no complications reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: only the main coil was returned analysis.The main coil was kinked and stretched.No more damages were found.
 
Event Description
It was reported that the coil has come out of the catheter.The target lesion was located in the moderately tortuous and non-calcified internal iliac artery.A 8mm x 20cm.035 interlock cube embolics was selected for use.During delivery of the product, a gutter was created by breaking through the wall of the catheter instead of the tip and the coil has come out of the catheter.The entire catheter was removed, however, two-thirds of the coil protruded from the tip.The procedure was completed with a different device.There were no complications reported.
 
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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
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key14880660
MDR Text Key302940642
Report Number2134265-2022-07244
Device Sequence Number1
Product Code KRD
UDI-Device Identifier08714729793052
UDI-Public08714729793052
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K133208
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 08/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/25/2023
Device Model Number83787
Device Catalogue Number83787
Device Lot Number0025269719
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDE CATHETER-4FR IMPRESS; GUIDE CATHETER-4FR IMPRESS; GUIDEWIRE-RADIFOCUS; GUIDEWIRE-RADIFOCUS
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