MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FILTERWIRE EZ; TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION

Model Number 44150

Device Problems Failure to Advance (2524); Material Integrity Problem (2978)

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

Event Date 12/10/2021

Event Type  malfunction  

Event Description

It was reported that the filter was broken.During advancement of the filterwire ez through a carotid artery stent the filterwire ez was stuck.The device was pushed harder because of calcification and once the device crossed through the stent the filter was observed to be breaking off the filterwire ez.The wire together with the filter was removed from the patient.The procedure was then completed with the use of another filter without problems.No patient complications were reported.

Event Description

It was reported that the filter was broken.During advancement of the filterwire ez through a carotid artery stent the filterwire ez was stuck.The device was pushed harder because of calcification and once the device crossed through the stent the filter was observed to be breaking off the filterwire ez.The wire together with the filter was removed from the patient.The procedure was then completed with the use of another filter without problems.No patient complications were reported.

Manufacturer Narrative

Device eval by manufacturer: the wire returned inside the delivery sheath, and the filter came back in an undeployed state.Additionally, it was possible to observe that the wire was exposed through the sheath slit; consequently, the reported issue related to delivery sheath difficult/failure to cross lesion was confirmed due to the device condition.However, the device was inspected and no broken or detachment sections were noted, therefore, the reported issue related to filterwire device/component broken/separated during procedure was not confirmed.

• Brand Name: FILTERWIRE EZ
• Type of Device: TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13057890
• MDR Text Key: 282612439
• Report Number: 2134265-2021-16070
• Device Sequence Number: 1
• Product Code: NFA
• Combination Product (y/n): N
• Reporter Country Code: HU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2022
• Device Model Number: 44150
• Device Catalogue Number: 44150
• Device Lot Number: 0026509627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2020
• 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
• Patient Age: 56 YR
• Patient Sex: Male