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

Model Number 83779

Device Problems Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: visual inspection was performed.The main coil, the pusher wire and the introducer sheath returned for the analysis.The main coil was stuck inside the introducer sheath, and it was necessary to make cuts on the introducer to free the coil.On the device it was observed that the main coil stretched and kinked.Additionally, it was detached at the coil arm section.No more damages were observed.Under the microscope it was observed the main coil stretched and kinked.Additionally, it was detached at the coil arm section.The functional inspection could not be performed because the main coil and the pusher wire are not interlocking.Dimensional inspection was performed, and the zap tip and primary coil outer diameter passed the test.

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that advancing difficulties were encountered.The target lesion was located in the splenic artery.A 8mm x 20cm f-idc 2d coil was selected for use.During the procedure, the coil was advanced into the middle part of the delivery system but could no longer be advanced.The coil was removed and the procedure was completed with a different device.No patient complications were reported.However, returned device analysis revealed a detached coil at the arm section.

• Brand Name: INTERLOCK
• Type of Device: 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17343637
• MDR Text Key: 319611327
• Report Number: 2124215-2023-36643
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729765011
• UDI-Public: 08714729765011
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2023

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
• Device Operator: Health Professional
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0030284346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MICROCATHETER: STC 18
• Patient Age: 58 YR
• Patient Sex: Male