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

Model Number	83779
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter title: inventory control coordinator.Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed that the device returned without the pusher wire and introducer sheath.The main coil was observed stretched, kinked and detached.Fiber were lost due to coil condition.Unknown device was returned with the coil.No more damages were observed.Microscope inspection revealed that the main coil coil was observed stretched, kinked and detached.Fiber were lost due to coil condition.
Event or Problem Description
Reportable based on device investigations completed on 21jun2022.It was reported that the device did not deploy.A 4mm x 8cm pe f-idc interlock embolics was selected for use.During the procedure, it was noted that the device did not deploy.The procedure was completed with another of the same device.There were no complications reported.However, device investigations revealed that the main coil was detached and fiber was lost.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14991253
• Report Number: 2134265-2022-07627
• Device Sequence Number: 1880783
• Product Code: KRD
• UDI-Device Identifier: 08714729764953
• UDI-Public: 08714729764953
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2022

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: 05/03/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027428963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2021
• 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