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

Model Number	7577
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2021 as no event date was reported.
Event or Problem Description
It was reported that the device basket part was crunched when deployed.A 2.25mm-3.5mm 190cm filterwire ez was selected for use.During the procedure, when the device was deployed, it was noted that the basket part of the device crunched.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that the device basket part was crunched when deployed.A 2.25mm-3.5mm 190cm filterwire ez was selected for use.During the procedure, when the device was deployed, it was noted that the basket part of the device crunched.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
B3 date of event: date of event was approximated to (b)(6) 2021 as no event date was reported.Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.The wire returned inside the delivery sheath and the filter bag came back in deployed state.The distal section of the device was deformed at the delivery sheath.No other issues were identified in the device.Functional inspection was performed and during the sheathing/unsheathing test, the filter was unable to sheath due to the sheath condition.

• Brand Name: FILTERWIRE EZ
• Common Device Name: 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 DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12639025
• Report Number: 2134265-2021-12654
• Device Sequence Number: 3292276
• Product Code: NFA
• UDI-Device Identifier: 08714729808800
• UDI-Public: 08714729808800
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K061332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2021

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: 01/27/2023
• Device Model Number: 7577
• Device Catalogue Number: 7577
• Device Lot Number: 0026705851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• 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 Sex: Unknown