MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83779
Medical Device Problem Codes	Entrapment of Device (1212); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that a coil protrusion occurred during removal.The target lesion was located in a severely tortuous blood vessel.A 6mm x 10cm interlock was selected for use.During the procedure, the device got stuck inside the microcatheter.Subsequently, only the coil was removed and it was noted that the coil protruded from the tip of the catheter.The procedure was completed with another of the same device.No complications were reported and patient was good post procedure.
Additional Manufacturer Narrative
E1: initial reporter address 1 - (b)(6).H2: correction - coding updated from material protrusion/extrusion to entrapment of device.
Event or Problem Description
It was reported that a coil protusion occurred during removal.The target lesion was located in a severely tortuous blood vessel.A 6mm x 10cm interlock was selected for use.During the procedure, the device got stuck inside the microcatheter.Subsequently, only the coil was removed and it was noted that the coil protruded from the tip of the catheter.The procedure was completed with another of the same device.No complications were reported and patient was good post procedure.

• 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 Key: 9910273
• Report Number: 2134265-2020-04135
• Device Sequence Number: 19671575
• Product Code: KRD
• UDI-Device Identifier: 08714729764991
• UDI-Public: 08714729764991
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2020

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 Date: 03/31/2020
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0020479344
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER - EXCELSIOR 1080; CATHETER - EXCELSIOR 1080; CATHETER - EXCELSIOR 1080