MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FILTERWIRE EZ; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number 44150

Device Problems Fracture (1260); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2019

Event Type  malfunction  

Event Description

It was reported that the device broke.The target lesion was located in the internal and common carotid artery.A 190cm filterwire ez was selected for use.During procedure, severe resistance was met upon inserting the filter and it could not advance to the tip.The device was then removed, re-prepped and re-inserted again but severe resistance was met and, the device broke/kinked.The procedure was completed with another of the same device.There were no patient complications reported.

• Brand Name: FILTERWIRE EZ
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol,; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8722709
• MDR Text Key: 148795879
• Report Number: 2134265-2019-07248
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063313
• 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: 06/21/2019

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 Expiration Date: 01/07/2021
• Device Model Number: 44150
• Device Catalogue Number: 44150
• Device Lot Number: 0023154054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2019
• 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: 75 YR