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

Model Number	83779
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	11/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the patient experienced thrombus formation.The target lesion was located in a renal artery.A 14mm x 30cm interlock coil was selected for use.During the procedure, when the physician advanced and adjusted the coil into the tumor, it was noted that a thrombus formed and became stuck in the non-bsc microcatheter.Furthermore, the coil could not be deployed.The coil was removed with the catheter from the patient without any interventions and the procedure was completed with another of the same device.No further patient complications were reported and patient was stable post procedure.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.Device evaluated by mfr: the device was returned for evaluation.A pusher wire and hoop were returned for this complaint.The coil and introducer sheath were not returned.The pusher wire was inspected and was found kinked.No more damages were found in the returned device.The proximal end has a smooth surface.The interlocking arm was inspected and no anomalies were noted.The main coil was not returned.Dimensional inspection of the pusher wire revealed that the components were within specification.
Event or Problem Description
It was reported that the patient experienced thrombus formation.The target lesion was located in a renal artery.A 14mm x 30cm interlock coil was selected for use.During the procedure, when the physician advanced and adjusted the coil into the tumor, it was noted that a thrombus formed and became stuck in the non-bsc microcatheter.Furthermore, the coil could not be deployed.The coil was removed with the catheter from the patient without any interventions and the procedure was completed with another of the same device.No further patient complications were reported and patient was stable 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: 9444450
• Report Number: 2134265-2019-15263
• Device Sequence Number: 16704918
• Product Code: KRD
• UDI-Device Identifier: 08714729765073
• UDI-Public: 08714729765073
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/07/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0023632753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2019
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention