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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IDC; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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BOSTON SCIENTIFIC CORPORATION IDC; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number 83735
Device Problems Entrapment of Device (1212); Premature Activation (1484)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2023
Event Type  malfunction  
Event Description
It was reported that the coil protruded from catheter tip upon removal.The target lesion was located in the severely tortuous and non-calcified celiac artery.A 12mm x 20cm idc-18 coil was selected for use.During the procedure, it was noted that the coil detached early within the distal part of the catheter (the main coil and the arm of the delivery wire were separated).Also, it was found under fluoroscopy that the locking arm part got stuck.The coil was removed together with the catheter and protruded from the tip.The procedure was completed with another of the same device.No patient complications reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: only the main coil was returned for product analysis.Visual inspection revealed that the mail coil was found stretched and kinked.Since only the main coil returned the functional inspection could not be performed.For dimensional inspection of the main coil, the zap tip and primary coil outer diameter were within specification.
 
Event Description
It was reported that the coil protruded from catheter tip upon removal.The target lesion was located in the severely tortuous and non-calcified celiac artery.A 12mm x 20cm idc-18 coil was selected for use.During the procedure, it was noted that the coil detached early within the distal part of the catheter (the main coil and the arm of the delivery wire were separated).Also, it was found under fluoroscopy that the locking arm part got stuck.The coil was removed together with the catheter and protruded from the tip.The procedure was completed with another of the same device.No patient complications reported.
 
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Brand Name
IDC
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 Key16428239
MDR Text Key310069615
Report Number2124215-2023-04906
Device Sequence Number1
Product Code KRD
Combination Product (y/n)N
Reporter Country CodeJA
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 03/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number83735
Device Catalogue Number83735
Device Lot Number0027790835
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/06/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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