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

Model Number	83786
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Only a main coil was returned for this complaint.The main coil was found kinked and stretched.The fiber bundles have blood residues.No more damages were found in the returned device.Microscopic inspection was performed on the main coil and observed that the zap tip has a smooth surface.The interlocking arm was inspected, and it was found detached.Dimensional inspection on main coil was performed and revealed that the outer diameter (od) of the zap tip and primary coil were within specification, however the no.Of fiber bundles and proximal fiber bundles were incomplete.
Event or Problem Description
Reportable based on device analysis completed on 10mar2021.It was reported that the coil prematurely detached.A 4mm x 10cm interlock-35 was selected for use.During procedure, the coil detached early while advancing inside a 5fr catheter prior to implantation.The catheter was removed with coil inside and regain access to the portal vein.Pushable coils were used with no issues and the procedure was completed.No patient complications were reported.However, device analysis revealed a detached interlocking arm and incomplete fiber bundles.

• 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: 11600205
• Report Number: 2134265-2021-04081
• Device Sequence Number: 19885173
• Product Code: KRD
• UDI-Device Identifier: 08714729792987
• UDI-Public: 08714729792987
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2021

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: 08/15/2021
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0022521758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1