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

Model Number	83779
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was contaminated.A 3mm x 12cm interlock embolic coil was selected for use in a trans-arterial chemoembolization (tace).During preparation, the coil was being flushed by the technician.However, it got contaminated.The procedure was completed with another of the same device.No patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Unit returned with its original pouch batch 25004912, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.Visual inspection revealed that a pusher wire, coil and introducer sheath were returned for this complaint.The pusher wire was out of the introducer sheath, and it was kinked.The introducer sheath was inspected, and no anomalies were noted.The main coil was inspected, and no anomalies were found.Microscopic inspection revealed that the pusher wire's proximal end has a smooth surface.The interlocking arm was inspected, and no anomalies was noticed.The main coil revealed that the zap tip has a smooth surface and the interlocking arm was inspected, and no anomalies were noticed.Dimensional inspection revealed that overall dimension (od) of the distal solder joint, mid solder joint, distal tfe and proximal tfe were within specification while for the main coil, the zap tip (od), primary coil (od) and the number of fiber bundlels were within specification.
Event or Problem Description
It was reported that the device was contaminated.A 3mm x 12cm interlock embolic coil was selected for use in a trans-arterial chemoembolization (tace).During preparation, the coil was being flushed by the technician.However, it got contaminated.The procedure was completed with another of the same device.No patient complications 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: 11244412
• Report Number: 2134265-2021-00766
• Device Sequence Number: 3556441
• Product Code: KRD
• UDI-Device Identifier: 08714729764946
• UDI-Public: 08714729764946
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

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: 12/08/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0025004912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR