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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 Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter facility name: (b)(6).
 
Event Description
It was reported that a foreign metal was detached from the protective sheath.A 3mmx6cm interlock coil was selected for use.During the procedure, embolization was performed with a total of three free coils and one controllable coil were used.Consequently, after opening the package of the 3mmx6cm coil, it was found that a foreign metal detached from the protective sheath.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable.
 
Manufacturer Narrative
E1.Initial reporter facility name: (b)(6) college.Device evaluated by manufacturer: the device was returned for analysis.A pusher wire and introducer sheath were returned for this complaint.The twist lock of the introducer sheath had been opened.The introducer sheath was inspected, and no anomalies were noted.The pusher wire was inspected, and no damages was found.The proximal end has a smooth surface.The interlocking arm was inspected, and no anomalies were noticed.
 
Event Description
It was reported that a foreign metal was detached from the protective sheath.A 3mmx6cm interlock coil was selected for use.During the procedure, embolization was performed with a total of three free coils and one controllable coil were used.Consequently, after opening the package of the 3mmx6cm coil, it was found that a foreign metal detached from the protective sheath.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable.
 
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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 Key12247569
MDR Text Key264143526
Report Number2134265-2021-09753
Device Sequence Number1
Product Code KRD
UDI-Device Identifier08714729764939
UDI-Public08714729764939
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,distri
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 Received07/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/01/2023
Device Model Number83779
Device Catalogue Number83779
Device Lot Number0026442887
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2021
Date Manufacturer Received08/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age23 YR
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