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

Model Number 83779

Device Problem Premature Activation (1484)

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

Event Date 10/19/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.Only a main coil returned for this complaint.Main coil was found kinked and stretched.The pusher wire was inspected, and it was found kinked.No more damages were found in the device.Microscopic inspection was performed on the main coil.The zap tip was detached.The interlocking arm was detached.Dimensional iinspection on the main coil revealed that the zap tip od (max) (outer diameter), primary coil od were within specification.However, the number of fiber bundles were incomplete.

Event Description

Reportable based on device analysis completed on 01dec2021.It was reported that the coil prematurely detached.The target lesion was located in the internal iliac artery.A 18mm x 50cm interlock coil was selected for use.During the procedure, it was reported that the coil detached early from the interlocking arm.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.However, device analysis revealed that the zap tip and interlocking arm were detached and the fiber bundles were incomplete.

• Brand Name: INTERLOCK
• Type of Device: 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 ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13004804
• MDR Text Key: 282558452
• Report Number: 2134265-2021-15496
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729845300
• UDI-Public: 08714729845300
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026818072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2021
• 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
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 67 KG