MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83788
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this interlock-35 embolic coil was analyzed.Visual inspection revealed the main coil was kinked and stretched, and the fiber bundles had blood residue.Microscopic inspection of the mail coil showed the zap tip had a smooth surface.The interlocking arm was noted to be detached and was not returned.Dimensional inspection of the main coil showed measurements within specifications; however, there were missing distal fiber bundles, due to the coil stretching.
Event or Problem Description
Reportable based on device analysis completed on 02jun2021.An interlock-35 embolic coil was selected for use in a coiling procedure, to treat an aneurysm.During the procedure, the pusher wire arms could not be detached in the vessel.Continuous flushing and manipulation was performed to detach the wire, but it did not work.The coil was removed via the catheter and the procedure was completed with another interlock-35 embolic coil.No patient complications were reported.However, device analysis revealed the interlocking arm was detached.

• Brand Name: INTERLOCK-35
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11996943
• Report Number: 2134265-2021-07547
• Device Sequence Number: 1008979
• Product Code: KRD
• UDI-Device Identifier: 08714729796114
• UDI-Public: 08714729796114
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2021

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: 09/01/2022
• Device Model Number: 83788
• Device Catalogue Number: 83788
• Device Lot Number: 0024360324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1