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

Model Number 83777

Device Problems Premature Activation (1484); Stretched (1601)

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

Event Date 08/16/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).Device evaluated by mfr: the device was returned for analysis.The pusher wire, the main coil and the rhv were returned for this complaint, the introducer sheath did not return.The pusher wire was inspected, and it was found kinked.The main coil was inspected and was found stretched and kinked.The main coil and the pusher wire returned separate.No more damages were found.Microscopic inspection of the pusher wire was performed, and it was found kinked.The proximal end has a smooth surface.The interlocking arm was inspected, and no anomalies were noted.Microscopic inspection of the main coil was performed and revealed that the zap tip from the distal end has a smooth surface.The distal end was found kinked and stretched.The interlocking arm was inspected, and no anomalies were noted.Dimensional inspection of the pusher wire was performed and the measured dimensions were within specification.Dimensional inspection of the main coil was performed and there were missing fiber bundles.The remaining measured dimensions were within specification.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 16sep2021.It was reported that the coil prematurely detached in the catheter.A vortx diamond 2/4mm x 4.1cm interlock coil was selected for use.During the procedure, it was noted that the coil prematurely detached in the catheter.Per physician's comment, there was unravelling caused by the device.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed missing fiber bundles.

• Brand Name: INTERLOCK
• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12585019
• MDR Text Key: 275006097
• Report Number: 2134265-2021-12295
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729765097
• UDI-Public: 08714729765097
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2023
• Device Model Number: 83777
• Device Catalogue Number: 83777
• Device Lot Number: 0025851399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2020
• 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