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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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BOSTON SCIENTIFIC CORPORATION INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number 83779
Device Problem Premature Activation (1484)
Patient Problems Embolism/Embolus (4438); Insufficient Information (4580)
Event Date 07/27/2021
Event Type  Injury  
Event Description
It was reported that the coil deployed in an inaccurate vessel and could not be removed.The target lesion was located in the common hepatic artery.A 6mm x 10cm interlock was selected for use.During the procedure, it was noted that after placing two 4 x 8 coils in the gastroduodenal artery (gda), the physician was unhappy with the placement of the third coil and so he tried to retract it.However, the coil deployed close to the common hepatic artery and was tried to retrieve with a snare but was unsuccessful.Subsequently, the coil was tried to advance by pushing a glide catheter to try to push the coil further to gda but was unsuccessful again.Consequently, the procedure was cancelled, and patient sent for surgery the next day.No further patient complications reported.
 
Event Description
It was reported that the coil deployed in an inaccurate vessel and could not be removed.The target lesion was located in the common hepatic artery.A 6mm x 10cm interlock was selected for use.During the procedure, it was noted that after placing two 4 x 8 coils in the gastroduodenal artery (gda), the physician was unhappy with the placement of the third coil and so he tried to retract it.However, the coil deployed close to the common hepatic artery and was tried to retrieve with a snare but was unsuccessful.Subsequently, the coil was tried to advance by pushing a glide catheter to try to push the coil further to gda but was unsuccessful again.Consequently, the procedure was cancelled, and patient sent for surgery the next day.No further patient complications reported.
 
Manufacturer Narrative
F10.Updated patient code from insufficient information to embolism/embolus.F10.Updated impact code from additional surgery and surgical procedure delayed to additional surgery only.
 
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Brand Name
INTERLOCK
Type of Device
DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12337960
MDR Text Key267113609
Report Number2134265-2021-10450
Device Sequence Number1
Product Code KRD
Combination Product (y/n)N
PMA/PMN Number
K132578
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number83779
Device Catalogue Number83779
Was Device Available for Evaluation? No
Date Manufacturer Received08/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MICROCATHETER-RENEGADE STC; MICROCATHETER-RENEGADE STC; MICROCATHETER-RENEGADE STC
Patient Outcome(s) Other;
Patient Age75 YR
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