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

Model Number 83786

Device Problems Entrapment of Device (1212); Premature Activation (1484); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

Event Type  malfunction  

Event Description

It was reported that the coil damaged a balloon.The target lesion was located in a moderately tortuous subclavian artery.A 8mm x 40cm interlock-35 coil was selected for use.During a subclavian embolization, a 8mm x 20cm interlock coil was attempted to place in a non bsc parent catheter.However, the interlocking arm part was caught near the tip of the catheter and coil could no longer come out from the catheter's tip.When coil was viewed under fluoroscopy, the back part of the interlocking arm on the pusher side was located outside and the interlocking arm and the pusher seemed to be bent.Consequently, slight force was applied and when the pusher wire was pushed to remove the bent part from the outside, the interlocking arm come out from the catheter's tip.The coil was able to be placed.Then, the 8mm x 40cm interlock-35 coil was used; however, the coil was detached early and could not be removed from the non bsc parent catheter tip.The pusher wire penetrated the non bsc inner catheter causing the its balloon to rupture.The coil was implanted and the balloon was retrieved.No patient complications reported.

• 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; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9395801
• MDR Text Key: 174576516
• Report Number: 2134265-2019-14639
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729793014
• UDI-Public: 08714729793014
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133208
• 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: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0020518956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2017
• 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