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

Model Number	83779
Medical Device Problem Codes	Component Missing (2306); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil was missing upon removal.A 3mm x 6cm interlock coil was selected for use in an embolization procedure in the head and neck.During the procedure, when the delivery system was advanced through the direxion catheter, the physician could not verify if the coil was detached.When attempting to detach the coil at the target site, detachment was not observed.However, when the delivery system was removed it was noted that the coil was missing.The procedure was completed with another of the same device.There was no patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: a pusher wire, the main coil and introducer sheath were returned for this complaint.A visual inspection noted that a the introducer sheath was inspected and no anomalies were noted, the twist lock of the introducer sheath had been opened.Besides, blood residues were noted within the introducer sheath.The pusher wire was inspected and no anomalies were noted.The main coil did not show damages.A functional inspection noted that the delivery wire was advanced through the introducer sheath, but it was not possible to continue advancing it due to the main coil was stuck, possibly caused by the dry blood found inside; it was necessary to cut the sheath in order to release the main coil.A microscopic inspection noted that proximal end of the pusher wire has a smooth surface and the interlocking arm was inspected and no anomalies were noted.The zap tip of the main coil has a smooth surface.The main coil did not show damages.The interlocking arm was inspected and no anomalies were noted.The dimensions that could be measured were are within specification.No other issues noted on the analysis.
Event or Problem Description
It was reported that the coil was missing upon removal.A 3mm x 6cm interlock coil was selected for use in an embolization procedure in the head and neck.During the procedure, when the delivery system was advanced through the direction catheter, the physician could not verify if the coil was detached.When attempting to detach the coil at the target site, detachment was not observed.However, when the delivery system was removed it was noted that the coil was missing.The procedure was completed with another of the same device.There was no patient complications reported and the patient's status was stable.

• 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: 7947980
• Report Number: 2134265-2018-61689
• Device Sequence Number: 856721
• Product Code: KRD
• UDI-Device Identifier: 08714729764939
• UDI-Public: 08714729764939
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 02/01/2019

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: 01/20/2021
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0021764265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 70