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

Model Number	83779
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by manufacturer.The device was returned for analysis.A visual and microscopic inspection noted that the main coil was returned for this complaint.The pusher wire and introducer sheath were not returned for this complaint.The coil was returned stretched in middle of the core near to interlocking arm and zap tip.No more damages were found in the device.The zap tip of the main coil has a smooth surface.The interlocking arm was inspected and no anomalies were noted.The dimensional inspection of the main coil revealed that the maximum outer diameter (od) zap tip and primary coil (od) were within its specification, however some of the fiber bundles were missing.
Event or Problem Description
Reportable based on device analysis completed on 05feb2020.It was reported that the coil was stuck inside the microcatheter.The target lesion was located in the moderately tortuous and mildly calcified iliac artery vein arteriovenous fistula.A 3mm x 12cm interlock coil was selected for use in a vascular embolization.During the procedure, it was noted that the coil was stuck inside the microcatheter.The arm of the coil was connected during preparation with the introducer sheath fit in the hub during coil insertion.During advancement, the delivery wire was not rotated more than once with the twist lock completely opened.The procedure was completed with another of the same device.No patient complications reported.However, device analysis revealed missing fiber bundle.

• 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: 9711332
• Report Number: 2134265-2020-01551
• Device Sequence Number: 13541471
• Product Code: KRD
• UDI-Device Identifier: 08714729764946
• UDI-Public: 08714729764946
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/14/2020

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 Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0023982891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1