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

Model Number	83779
Medical Device Problem Codes	Premature Activation (1484); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.(b)(6).Device evaluated by manufacturer: the device was returned for analysis.The main coil returned with a part of the introducer sheath, and a part of the pusher wire for the analysis.Visual and microscopic inspection revealed that the main coil was bent and stretched at the coil arm section and middle section.Additionally, it was observed that the pusher wire was detached and kinked at the middle section, and the introducer was observed detached.The pouch was returned, and it was observed that the pouch information matches with the complaint information.No more damages were observed.The functional inspection could not be performed, because the main coil and the pusher wire are not interlocking.The dimensional inspection revealed that the outer diameter (od) at the coil arm, zap tip and primary coil were found to be within specification.
Event or Problem Description
Reportable based on the device analysis completed on 03oct2023.It was reported that the coil was difficult to advance and prematurely deployed.The target lesion was located in the severely tortuous splenic artery.An 4mm x 15cm interlock was selected for use.During the procedure, it was noted that resistance was felt when advancing the coil through the direxion transend microcatheter, although the coil was properly flushed before insertion and continuous flush was maintained.Also, the coil got deployed inside the microcatheter.The coil was removed together with the microcatheter.The device was bent or kinked.The procedure was complete with a different device.There were no patient complications reported post procedure.However, device analysis revealed that the pusher wire and introducer got detached.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18005415
• Report Number: 2124215-2023-57285
• Device Sequence Number: 7638491
• Product Code: KRD
• UDI-Device Identifier: 08714729764960
• UDI-Public: 08714729764960
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2023

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: 01/03/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0028802585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2022
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Race: Asian