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

Model Number 83787

Device Problems Difficult to Remove (1528); Failure to Advance (2524)

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

Event Date 06/13/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 07aug2023.It was reported that the device was unable to be advanced and withdrawn from the microcatheter.The patient underwent a stent placement procedure in the abdominal aorta.The target lesion was located in the internal iliac artery.A 20mm x 40cm interlock-35 was selected for use.During the procedure, the coil could not move forward nor be withdrawn from the distal area of the microcatheter.The coil was removed together with the catheter.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.However, device analysis revealed that the device was detached at the coil arm section.

Manufacturer Narrative

Device evaluated by manufacturer: only the main coil was returned for the analysis.Visual and microscopic inspection revealed that the main coil was bent, stretched and detached at the coil arm section.No more damages or issues were observed.The functional test could not be performed due only the main coil was returned for the analysis.Dimensional inspection revealed that the zap tip od (outer diameter) and primary coil od were within 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17642516
• MDR Text Key: 322181876
• Report Number: 2124215-2023-44588
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729795445
• UDI-Public: 08714729795445
• 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: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0030857650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2023
• 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
• Treatment: 5F CORDIS CATHETER.
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 60 KG