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

Model Number 83779

Device Problems Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

Device eval by mfr: the device was received and analysis was completed.Only a pusher wire was returned.The coil was not returned.The pusher wire was inspected and was found kinked, broken and stretched.No more damages were found in the returned device.Microscopic inspection revealed the proximal end has a smooth surface.The interlocking arm was detached.Dimensional inspection revealed the device met specification.

Event Description

Reportable based on device analysis completed on 07dec2021.It was reported that the coil prematurely deployed.A f-idc 2d 5mm x 8cm interlock coil was selected for use in an artery embolization procedure.During deployment, the coil prematurely deployed in the catheter.It could not be deployed to the target location.However, device analysis revealed a detached interlocking arm.

• Brand Name: INTERLOCK
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13022205
• MDR Text Key: 282394465
• Report Number: 2134265-2021-15777
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729764977
• UDI-Public: 08714729764977
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K132578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2023
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026096143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1