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

Model Number	83779
Medical Device Problem Codes	Entrapment of Device (1212); Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A pusher wire and two coils were returned for this complaint; the coils were stuck inside a non-bsc catheter.The introducer sheath was not returned.The fiber bundles of both coils had blood on them as well as inside the catheter.The pusher wire returned inside the catheter and it was found in a wrong position, it was loaded from the wrong side; besides, it had a kink near the distal tip.The coils were returned in good condition, however, they got stretched when they were removed from the catheter.The pusher wire was advanced through the catheter, but it was not possible to continue advancing it due to the main coils were stuck; it was necessary to cut the catheter in order to release the main coil.During the process the coil got stretched.Microscopic inspection of the pusher wire revealed that the proximal end has a smooth surface, the interlocking arm was inspected and no anomalies were noted and the distal section of the wire was kinked.The main coil was also inspected and the zap tip has a smooth surface and the main coil got stretched when it was removed from the catheter.Dimensional inspection revealed that there are missing fiber bundles.
Event or Problem Description
Reportable based on device analysis completed on 20-dec-2018.It was reported that the coil was jammed and detached inside catheter.A 10mm/30cm interlock was selected for embolization.During the procedure, the coil was initially jammed and then detached inside a non-bsc catheter.The procedure was completed with another of same device.No patient complications reported.However, device analysis revealed that there were 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
• MDR Report Key: 8249344
• Report Number: 2134265-2018-65111
• Device Sequence Number: 13842292
• Product Code: KRD
• UDI-Device Identifier: 08714729765035
• UDI-Public: 08714729765035
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 01/15/2019

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: 10/31/2019
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0019921156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1