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

Model Number	83779
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil detachment occurred.And some part was placed in the aneurysm.The target lesion was located in the severely tortuous hepatic artery.A 18mm x 50cm interlock coil was selected for use.During the procedure, placement of the coil became difficult.In attempts to retrieve the coil while inside the microcatheter the coil became unraveled.The coil detached in attempts to remove it via a snare.The microcather moved proximally and the detached coil (10cm) was implanted within the patient.The physician noted that thrombosis formation progress while trying to deploy the coil by changing its shape several times.The procedure was rescheduled.No further patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A pusher wire and a severely damaged coil were returned for this complaint.The pusher wire was inspected and was found kinked near the interlocking arm.The section of the coil that was returned was found broken since the entire device was not returned; in addition, it was found stretched and kinked.Microscopic inspection of the pusher wire was performed and obseved that the proximal end has a smooth surface.The interlocking arm was inspected and no anomalies were noted.The section of the main coil that was returned was inspected and it was found broken, stretched and kinked.Dimensional inspection that could be measured for the pusher wire were performed and were within specification.It was not possible to perform dimensional testing of the main coil in the section of the coil returned due to the severely damaged condition of it.
Event or Problem Description
It was reported that the coil detachment occurred.And some part was placed in the aneurysm.The target lesion was located in the severely tortuous hepatic artery.A 18mm x 50cm interlock coil was selected for use.During the procedure, placement of the coil became difficult.In attempts to retrieve the coil while inside the microcatheter the coil became unraveled.The coil detached in attempts to remove it via a snare.The microcather moved proximally and the detached coil (10cm) was implanted within the patient.The physician noted that thrombosis formation progress while trying to deploy the coil by changing its shape several times.The procedure was rescheduled.No further patient complications were 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: 8604732
• Report Number: 2134265-2019-05131
• Device Sequence Number: 1857544
• Product Code: KRD
• UDI-Device Identifier: 08714729845300
• UDI-Public: 08714729845300
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/21/2021
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0022541287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 07/02/2019
• 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: INTRODUCER SHEATH - DESTINATION; INTRODUCER SHEATH - DESTINATION; MICROCATHETER - PROGREAT; MICROCATHETER - PROGREAT; INTRODUCER SHEATH - DESTINATION; MICROCATHETER - PROGREAT
• Outcome Attributed to Adverse Event: Required Intervention