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

Model Number 83787

Device Problems Premature Activation (1484); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/27/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: visual inspection was performed.Only the main coil returned for the product analysis.The main coil returned kinked, stretched and detached in the interlocking arm.Functional inspection, since only the main coil returned for product analysis the functional inspection could not to be performance.

Event Description

Reportable based on device analysis completed on 09feb2023.It was reported that coil advancing issue occurred.The target lesion was located in the left renal artery.A 10mm x 40cm interlock cube coil was selected for use.During the procedure, the coil was found unloaded and stuck in the catheter.The device was unable to be pushed after several attempts.The procedure was completed by another of the same device.No patient complications were reported and the patient status was stable.However, returned device analysis revealed a detached interlocking arm.

• Brand Name: INTERLOCK-35
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16452023
• MDR Text Key: 310331295
• Report Number: 2124215-2023-08780
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729795513
• UDI-Public: 08714729795513
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• 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: 0028802517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2022
• 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
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 65 KG