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

Model Number	83777
Medical Device Problem Codes	Premature Activation (1484); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).Device evaluated by mfr: the device was returned for analysis.The pusher wire, the main coil and the rhv were returned for this complaint, the introducer sheath did not return.The pusher wire was inspected, and it was found kinked.The main coil was inspected and was found stretched and kinked.The main coil and the pusher wire returned separate.No more damages were found.Microscopic inspection of the pusher wire was performed, and it was found kinked.The proximal end has a smooth surface.The interlocking arm was inspected, and no anomalies were noted.Microscopic inspection of the main coil was performed and revealed that the zap tip from the distal end has a smooth surface.The distal end was found kinked and stretched.The interlocking arm was inspected, and no anomalies were noted.Dimensional inspection of the pusher wire was performed and the measured dimensions were within specification.Dimensional inspection of the main coil was performed and there were missing fiber bundles.The remaining measured dimensions were within specification.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 16sep2021.It was reported that the coil prematurely detached in the catheter.A vortx diamond 2/4mm x 4.1cm interlock coil was selected for use.During the procedure, it was noted that the coil prematurely detached in the catheter.Per physician's comment, there was unravelling caused by the device.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed missing fiber bundles.

• 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: 12585019
• Report Number: 2134265-2021-12295
• Device Sequence Number: 11709232
• Product Code: KRD
• UDI-Device Identifier: 08714729765097
• UDI-Public: 08714729765097
• 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): 10/06/2021

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: 07/13/2023
• Device Model Number: 83777
• Device Catalogue Number: 83777
• Device Lot Number: 0025851399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1