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

Model Number 83786

Device Problem Failure to Advance (2524)

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

Event Date 12/25/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 13feb2024.It was reported that the coil was stuck.The patient was being treated for internal iliac aneurysm.A 12mm x 40cm interlock.035 coil was selected for use.During the procedure, the coil was delivered halfway when it could no longer be advanced.The coil was withdrawn.The non-boston scientific imaging catheter was replaced, and an attempt was made to advance the same coil again.However, the coil became stuck again and could not be advanced.The coil was therefore removed and replaced with another of the same device.The procedure was successfully completed.No complications reported, and the patient was stable.However, device analysis revealed that the zap tip was detached.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that the main coil, the introducer sheath, rotating hemostasis valve (rhv), and the delivery wire were returned.It was observed that the main coil was bent and stretched at the coil arm and primary coil section.The zap tip was detached.Functional testing could not be performed since the main coil and the pusher wire were no longer interlocking.Dimensional inspection revealed that the outer diameters of the primary coil and the coil arm were within the specification.

• Brand Name: INTERLOCK-35
• 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 CORPORATION; 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: 18852439
• MDR Text Key: 337068698
• Report Number: 2124215-2024-09936
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729792970
• UDI-Public: 08714729792970
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• 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: 0029429728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2022
• 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: CORDIS 5F IMAGING CATHETER
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 70 KG