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

Model Number	83779
Medical Device Problem Codes	Component Missing (2306); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6) medical center.
Event or Problem Description
It was reported that the coil was damaged.A 3mmx12cm interlock coil was selected for use.During the procedure, it was noted that the coil was not attached.It is unknown whether the coil got early detached or the coil was not attached from the beginning.Per physician's comment, the device is the cause of this event.The procedure was completed with another of the same device.There was no patient injury.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) medical center.Correction to field b5: describe event or problem from "it was reported that the coil was damaged." to "it was reported that the coil was missing during the procedure." correction to field h6: device codes from "material integrity problem" to "missing component" device evaluated by mfr: the complaint device was received for product analysis.A pusher wire, and introducer sheath were returned for this complaint.The main coil did not return.The introducer sheath was inspected, and no anomalies were noted.The pusher wire was inspected, and no damages were found.No more damages were found in the returned device.Microscopic inspection of the pusher wire was performed and revealed that the proximal end has a smooth surface.The interlocking arm was inspected, and no anomalies were noticed.Dimensional inspection of the pusher wire was performed and the measured dimensions were within specification.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the coil was missing during the procedure.A 3mmx12cm interlock coil was selected for use.During the procedure, it was noted that the coil was not attached.It is unknown whether the coil got early detached or the coil was not attached from the beginning.Per physician's comment, the device is the cause of this event.The procedure was completed with another of the same device.There was no patient injury.

• 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: 12656112
• Report Number: 2134265-2021-12642
• Device Sequence Number: 1179694
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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: 12/13/2023
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026621119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1