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

Model Number	83779
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 22-nov-2018.It was reported that the coil unlocked inside the microcatheter.The target lesion was located in the splenic artery.A 14mmx20cm interlock coil was selected for use.During the procedure, after the physician retrieved the coil for repositioning, it was noted that the coil unlocked inside the microcatheter.The coil was removed with the catheter.The procedure was completed.No patient complications were reported and the patient's status post-procedure was stable.However; returned device analysis revealed that the interlocking arm was not returned since it is detached from the pusher wire.Device evaluated by manufacturer: the device was returned for analysis.A pusher wire and an introducer sheath were returned for this complaint.The coil was not returned.The twist lock of the introducer sheath had been opened.The introducer sheath was inspected and no anomalies were noted.The pusher wire was inspected and was found broken and stretched near the distal end.Microscopic inspection of the pusher wire revealed that the proximal end has a smooth surface.The interlocking arm was not returned since it is detached from the pusher wire.Dimensional inspection revealed that the device was within specification.

• 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: 8160235
• Report Number: 2134265-2018-63910
• Device Sequence Number: 2127175
• Product Code: KRD
• UDI-Device Identifier: 08714729765066
• UDI-Public: 08714729765066
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/13/2018

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: 03/24/2021
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0022029595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 12/13/2018
• Patient Sequence Number: 1