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

Model Number	83779
Medical Device Problem Codes	Contamination (1120); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.The main coil, pusher wire and introducer sheath were returned for this complaint.The main coil and the pusher wire were not interlocked within introducer sheath.The pusher wire and introducer sheath were inspected, no damages were noticed.The main coil was found kinked and stretched.No more damages were found in the device.Microscopic inspection was performed on the main coil.The zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies was noticed.Microscopic inspection was performed on the pusher wire.The proximal end has a smooth surface.The interlocking arm was inspected, and no anomalies was noticed.Dimensional inspection on the pusher wire revealed that the distal solder joint o.D.(outer diameter), mid solder joint o.D., distal tfe o.D.And proximal tfe o.D.Were within specification.Dimensional inspection on the main coil revealed that the zap tip od (max), primary coil od, number of fiber bundles were within specification.
Event or Problem Description
It was reported that the device got contaminated.The target lesion was located in the moderately tortuous and non calcified abdominal vessel.A 14mm x 50cm interlock coil was selected for use.During the procedure, when the coil was taken out from the dispenser, the coil unintentionally came out from the introducer sheath and became unclean.The procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was reported that the device got contaminated.The target lesion was located in the moderately tortuous and non calcified abdominal vessel.A 14mm x 50cm interlock coil was selected for use.During the procedure, when the coil was taken out from the dispenser, the coil unintentionally came out from the introducer sheath and became unclean.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.The main coil, pusher wire and introducer sheath were returned for this complaint.The main coil and the pusher wire were not interlocked within introducer sheath.The pusher wire and introducer sheath were inspected, no damages were noticed.The twist lock had been opened.The main coil was found kinked and stretched.No more damages were found in the device.Microscopic inspection was performed on the main coil.The zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies was noticed.Microscopic inspection was performed on the pusher wire.The proximal end has a smooth surface.The interlocking arm was inspected, and no anomalies was noticed.Dimensional inspection on the pusher wire revealed that the distal solder joint o.D.(outer diameter), mid solder joint o.D., distal tfe o.D.And proximal tfe o.D.Were within specification.Dimensional inspection on the main coil revealed that the zap tip od (max), primary coil od, number of fiber bundles 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 IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12711147
• Report Number: 2134265-2021-13260
• Device Sequence Number: 4703534
• Product Code: KRD
• UDI-Device Identifier: 08714729845294
• UDI-Public: 08714729845294
• 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,Followup
• Report Date (Section B): 11/05/2021

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: 04/27/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027400436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2021
• 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