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

Model Number	83779
Medical Device Problem Codes	Entrapment of Device (1212); Premature Activation (1484); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the coil protrudes from the catheter's tip upon removal.The target lesion was located in the moderately tortuous abdominal vessel.A 5mmx15cm interlock was selected for use to treat an aortic abdominal aneurysm.During the procedure, it was noted that the coil detached prematurely inside the microcatheter as the arm of the main coil and delivery wire got separated.The device was removed together with the microcatheter however, the coil protruded from the catheter's tip upon removal.The procedure was completed with another of the same device.There were no patient complications reported.

• 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: 10043979
• Report Number: 2134265-2020-06248
• Device Sequence Number: 11364043
• Product Code: KRD
• UDI-Device Identifier: 08714729764984
• UDI-Public: 08714729764984
• 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
• Report Date (Section B): 05/11/2020

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: 09/02/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0024535320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1