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

Model Number 83779

Device Problems Stretched (1601); Failure to Advance (2524)

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

Event Date 07/03/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The main coil was returned inside the introducer and the pusher wire also return for the analysis; it was necessary to make cuts to free the coil.Visual and microscope inspection revealed that the main coil was stretched, detached and bent at the coil arm section and the pusher wire was bent.No more damages were observed.The functional inspection could not be performed, because the main coil and the pusher wire are not interlocking.Dimensional inspection on the main coil revealed that the zap tip od - outer diameter (max) and the primary coil od were within specification.

Event Description

Reportable based on device analysis completed on 04sep2023.It was reported that the coil stuck in the middle of the catheter.The target lesion was located in the spermatic vein.A 4mm x 15cm interlock coil was selected for use.The device was continuously flush before introduction of the coil.During the procedure, a microcatheter was used to release two coils, however, upon deploying the second coil it got stuck in the middle of the catheter and could not be advance despite multiple attempts.When the coil was removed from the catheter, it was noted that the coil got stretched.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 main coil detached at the coil arm section.

• Brand Name: INTERLOCK
• 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: 17800291
• MDR Text Key: 324065419
• Report Number: 2124215-2023-49589
• Device Sequence Number: 1
• Product Code: KRD
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2023

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 Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0028008584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2021
• 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: 39 YR
• Patient Sex: Male
• Patient Weight: 79 KG