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

Model Number	83779
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A pusher wire, introducer sheath and main coil were returned for this complaint.The coil and pusher wire arms were not interlocked within introducer sheath.The coil was inspected, and it was found severely stretched and kinked.The pusher wire was inspected, it was kinked.No more damages were found in the returned device.A functional test was performed.The pusher wire was advanced through the introducer sheath, but it was not possible to continue advancing because the coil was stuck.It was necessary to cut the introducer sheath in order to release the main coil.Microscopic inspection of the pusher wire was performed and observed that the zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies were noted.Microscopic inspection of the main coil was performed and observed that the zap tip has a smooth surface.The interlocking arm was inspected, and it was found to be detached.Dimensional inspection of the pusher wire that could be measured was performed and dimensions were within specification.Dimensional inspection of the main coil that could be measured was performed and observed that the outer diameter (od) of the zap tip and primary coil were within specification.However, a number of fiber bundles were missing, due to the coil's stretched condition.
Event or Problem Description
Reportable based on device analysis completed on 07oct2021.It was reported that the coil detached in the catheter.The target lesion was located in the internal iliac artery.A 10mm x 50cm interlock was selected for use.During the procedure, the catheter and hub part of the direxion catheter broke when the coil was inserted.Both the coil and catheter were removed without any problems.However, the coil prematurely detached into the catheter.The procedure was completed with a different device.No patient complications reported.However, device analysis revealed that the interlocking arm detached and fiber bundles were lacking.

• 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: 12708354
• Report Number: 2134265-2021-13422
• Device Sequence Number: 4614091
• Product Code: KRD
• UDI-Device Identifier: 08714729845287
• UDI-Public: 08714729845287
• 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
• Report Date (Section B): 10/27/2021

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: 12/20/2023
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026657342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1