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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK INTERLOCK¿-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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BOSTON SCIENTIFIC - CORK INTERLOCK¿-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number M001363600
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/30/2017
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
 
Event Description
It was reported that the catheter used to deliver the coil perforated.The target lesion was severely tortuous.An interlock¿-35 was selected for use.During the portal vein embolization procedure, it was noted that a non-bsc catheter was perforated when the coil was delivered.The catheter and the coil were then removed as a unit.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by manufacturer: the device was returned for analysis.An unknown balloon catheter with two hubs, one of them labeled as "balloon" was returned for this complaint.After inspection under x-ray was confirmed that only the interlocking arm of the coil was present within this catheter, the rest of the coil was not found.Microscopic inspection of the main coil revealed that the interlocking arm was found kinked and detached from the rest of the coil.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.Dfu states: "the interlock - 35 fibered idc occlusion system is designed to be delivered under fluoroscopy through a 5f (1.70 mm) od (0.035 in [0.89 mm] or 0.038 in [0.97 mm] inner lumen) imager¿ ii selective diagnostic catheter without side flushing holes.The interlocking delivery wire design allows the coil to be advanced and retracted before final placement in the vessel, thus aiding in more controlled delivery including the ability to withdraw the coil prior to deployment." (b)(4).
 
Event Description
It was reported that the catheter used to deliver the coil perforated.The target lesion was severely tortuous.An interlock¿-35 was selected for use.During the portal vein embolization procedure, it was noted that a non-bsc catheter was perforated when the coil was delivered.The catheter and the coil were then removed as a unit.The procedure was completed with another of the same device.No patient complications were reported.
 
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Brand Name
INTERLOCK¿-35
Type of Device
DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
Manufacturer (Section D)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI 
Manufacturer (Section G)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI  
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7046369
MDR Text Key93180076
Report Number2134265-2017-11311
Device Sequence Number1
Product Code KRD
Combination Product (y/n)N
PMA/PMN Number
K110295
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/29/2020
Device Model NumberM001363600
Device Catalogue Number36-360
Device Lot Number20250604
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/06/2017
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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