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

Model Number	83779
Medical Device Problem Codes	Difficult to Insert (1316); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.A pusher wire, introducer sheath and main coil were returned.Pusher wire and main coil were interlocked within introducer sheath, coil was semi inside of the introducer sheath.The pusher wire was inspected, no damages were noticed.The coil was inspected and it was kinked and stretched.No more damages were found in the returned device.Microscopic inspection was performed on the pusher wire.The proximal end has a smooth surface.The interlocking arm was inspected and no anomalies was noted.Microscopic inspection on the main coil was performed.The zap tip was inspected and no damages were found.The interlocking arm was detached.Dimensional inspection revealed that the device met specification.
Event or Problem Description
Reportable based on device analysis completed on 02feb2022.It was reported that the interlocking arm part did not come out from the tip of the hoop and the interlock could not be advanced within the microcatheter.A 10mm x 30cm interlock coil was selected for use.The device was hydrated intermittently.However, during the procedure, part of the coil comes out of the hoop, but the locking arm part did not come out from the tip of the hoop.Furthermore, the interlock could not be advanced within the microcatheter.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that the interlocking arm was detached.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13573088
• Report Number: 2134265-2022-01356
• Device Sequence Number: 20320907
• Product Code: KRD
• UDI-Device Identifier: 08714729765035
• UDI-Public: 08714729765035
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/21/2022

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: 09/27/2023
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026256924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown