MAUDE Adverse Event Report: INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number 83786

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/24/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.Visual inspection was performed and it was observed that the main coil, the introducer sheath and the delivery wire were returned.It was necessary to make four cuts in the introducer wire to remove the coil.It was observed that the introducer wire was detached at twist lock section.The delivery wire was stretched and kinked at arm section.The main coil was bent and stretched at the coil arm, zap tip and primary coil section.Also, the main coil was detached at coil arm section.The pouch of the original box was returned, and it was observed that the pouch information matches with the complaint information.No more damages were observed during visual inspection.The functional could not be performed due the main coil was detached.Dimensional inspection of the main coil revealed the components were within specifications.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on (b)(6) 2024.It was reported that the coil was stuck in the microcatheter.An 8mm x 40cm interlock-35 coil was selected for splenic aneurysm embolization.During the procedure, the coil was delivered through a 5f catheter.However, it was noted that the coil got stuck and could not be advanced nor withdrawn.The coil was forced out of the patient's body with the catheter, and the procedure was completed with another of the same device.No patient complications were reported, and the patient was stable post-procedure.However, device analysis revealed a main coil detachment at the coil arm section.

• Brand Name: INTERLOCK-35
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• MDR Report Key: 18714856
• MDR Text Key: 336525637
• Report Number: 2124215-2024-04424
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• PMA/PMN Number: K133208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0031674456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2023
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 75 KG