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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspections revealed that the main coil and the pusher wire were interlocked inside the introducer sheath.It was observed that the main coil was stretched, and the pusher wire were kinked at serval parts.It is important to mention that the twist lock was opened.Functional inspection confirmed that the pusher wire and the main coil were advanced through the introducer sheath, but it was not possible to continue advancing it because the coil was stuck.Dimensional inspection revealed that the overall dimension (od) of the distal and mid solder joint, distal and proximal tfe of the pusher wire were within specification.For the main coil, the zap tip (od) and primary coil (od) were within the specification.However, the number of fiber bundles did not match with the specification.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2022.It was reported via medwatch 3600840000-2022-8073 that the coil was stuck with the pusher wire.A 18mm x 50cm pe f-idc interlock was selected for use.During the procedure, it was noted that the coil was stuck and would not unlatch from wire.The device was removed by removing the microcatheter and the procedure was completed with a different device.No patient complications reported.However, device investigation revealed missing fiber bundles.

• 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15758648
• Report Number: 2124215-2022-43598
• Device Sequence Number: 15012286
• Product Code: KRD
• UDI-Device Identifier: 08714729845300
• UDI-Public: 08714729845300
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2022

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: 04/25/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0029477644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER-0.021 BERN DIREXION.
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 188 KG