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

Model Number	83779
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil was fractured.The target lesion was located in the gastroduodenal artery.A 4mm x 8cm interlock coil was selected for use.The device was hydrated intermittently.During the procedure, it was noted that the device was fractured in the microcatheter.The physician was able to pull the pusher back and removed it completely.The procedure was completed with a different model.No patient complications were reported.
Event or Problem Description
It was reported that the coil was fractured.The target lesion was located in the gastroduodenal artery.A 4mm x 8cm interlock coil was selected for use.The device was hydrated intermittently.During the procedure, it was noted that the device was fractured in the microcatheter.The physician was able to pull the pusher back and removed it completely.The procedure was completed with a different model.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.Only the pusher wire and the introducer sheath were returned for this complaint.The main 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 it was found 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 detached.Dimensional inspection on the pusher wire revealed that the mid solder joint o.D.(outer diameter), distal tfe o.D.And proximal tfe o.D.Were 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
• 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: 13592910
• Report Number: 2134265-2022-01365
• Device Sequence Number: 5913130
• Product Code: KRD
• UDI-Device Identifier: 08714729764953
• UDI-Public: 08714729764953
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2022

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: 09/20/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0028244293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 04/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2021
• 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