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

Model Number	83779
Medical Device Problem Codes	Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2134265-2021-15777
• Device Sequence Number: 4948732
• Product Code: KRD
• UDI-Device Identifier: 08714729764977
• UDI-Public: 08714729764977
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown