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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
Medical Device Problem Code Entrapment of Device (1212)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/21/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Initial reporter city: (b)(6).
 
Event or Problem Description
It was reported that the coil protruded from the catheter tip.The target lesion area was located in the moderately tortuous abdominal artery.A 2mm x 6cm interlock 2mm x 6cm pe-f idc was selected for use.During the procedure, it was noted that the coil got stuck in the distal part of the catheter and protruded from the catheter tip upon removal.The device was removed the catheter and the procedure was completed with another of the same device.There were no complications reported and the patient is stable.
 
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Brand Name
INTERLOCK
Common Device Name
DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10363702
Report Number2134265-2020-10369
Device Sequence Number11524071
Product Code KRD
UDI-Device Identifier08714729845270
UDI-Public08714729845270
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K132578
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date10/27/2022
Device Model Number83779
Device Catalogue Number83779
Device Lot Number0024843069
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/21/2020
Initial Report FDA Received Date08/04/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
INTRODUCER SHEATH-TERUMO; MICRO CATHETER- LIGHTHOUSE
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