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

Model Number	83779
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2124215-2023-49589
• Device Sequence Number: 12558627
• Product Code: KRD
• UDI-Device Identifier: 08714729764960
• UDI-Public: 08714729764960
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/13/2024
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2023
• Initial Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 79 KG