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

Model Number	83779
Medical Device Problem Codes	Premature Activation (1484); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil prematurely detached inside the patient's body and was snared to remove.A 6mmx10cm interlock coil was selected for use on the uterine artery.During the procedure, it was noted that the coil prematurely detached inside the patient's body and a snare was used to remove the coil.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.
Event or Problem Description
It was reported that the coil prematurely detached inside the patient's body and was snared to remove.A 6mmx10cm interlock coil was selected for use on the uterine artery.During the procedure, it was noted that the coil prematurely detached inside the patient's body and a snare was used to remove the coil.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.It was further reported that the physician used renegade stc18 microcatheter to deliver the coil.At the beginning, the position of the coil was not suitable, and it was withdrawn and deployed again.Because the coil could not be pushed, it could only be withdrawn.The coil was detached during device removal.

• 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: 11930900
• Report Number: 2134265-2021-07032
• Device Sequence Number: 19955973
• Product Code: KRD
• UDI-Device Identifier: 08714729764991
• UDI-Public: 08714729764991
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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: 08/25/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0024492709
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 07/09/2021
• 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: MICROCATHETER - RENEGADE STC18
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 62