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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number 83786
Medical Device Problem Code Entrapment of Device (1212)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/13/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the coil protruded from the catheter tip upon removal.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified internal iliac artery.A 8mmx20cm interlock-35 was selected for use.During procedure, it was noted that the coil got stuck in the distal part of a 5f non-bsc catheter.The coil and catheter were then removed together, however the coil protruded from the catheter's tip.The procedure was completed with another of the same device.There were no patient complications reported.
 
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Brand Name
INTERLOCK-35
Common Device Name
DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10355809
Report Number2134265-2020-10274
Device Sequence Number16949513
Product Code KRD
UDI-Device Identifier08714729793045
UDI-Public08714729793045
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K133208
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) 08/03/2020
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 Date09/04/2022
Device Model Number83786
Device Catalogue Number83786
Device Lot Number0024380020
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/14/2020
Initial Report FDA Received Date08/03/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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