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

Model Number	83779
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis: visual inspection revealed that a pusher wire, mail coil, and introducer sheath were returned for this complaint.The introducer sheath and pusher wire were inspected, no damage was noticed.The main coil was found kinked and stretched.No more damage was noticed.Microscopic inspection of pusher wire revealed that the distal end has a smooth surface.The interlocking arm was inspected, and no anomalies were observed.Microscopic inspection of the main coil revealed that the zap tip has a smooth surface.The interlocking arm was detached.Dimensional inspection of the pusher wire and main coil revealed the components were within specification.
Event or Problem Description
Reportable based on device analysis completed on 26 january 2022.It was reported that the coil became stuck in the microcatheter.The target lesion was located in the moderately tortuous splenic artery.An 18mm x 50cm interlock was selected for use.During the procedure, the coil became stuck and could not advance through the microcatheter.The device was removed by withdrawing from the microcatheter.The procedure was completed with another of the same device.There were no patient complications.However, device analysis revealed that the interlocking arm was detached.

• 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 IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13481577
• Report Number: 2134265-2022-00984
• Device Sequence Number: 5084487
• Product Code: KRD
• UDI-Device Identifier: 08714729845300
• UDI-Public: 08714729845300
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2022

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: 08/02/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027954714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2021
• 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
• Patient Sex: Unknown