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

Model Number	7576
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that filter detachment occurred.A 300 cm filterwire was selected for use.During the course of the procedure, it was noted that the filter separated.The filter did not fall off and just slide to the end of the wire.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 12/01/2023 as the exact event date was not reported.
Event or Problem Description
It was reported that filter detachment occurred.A 300 cm filterwire was selected for use.During the course of the procedure, it was noted that the filter separated.The filter did not fall off and just slide to the end of the wire.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 12/01/2023 as the exact event date was not reported.Device evaluated by mfr: the device was returned for evaluation.The wire returned inside the delivery sheath and the filter bag came back in undeployed state.The spring tip was bent and stretched.The wire was kinked before filter.The pouch of the original box was returned, and it was observed that the pouch information matches with the complaint information.Under microscope magnification the spring tip was bent and stretched.Also, the wire was kinked before filter.Sheathing/unsheathing could not be performed, since the wire was kinked.No other issues were identified during the product analysis.

• Brand Name: FILTERWIRE EZ
• Common Device Name: TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18499382
• Report Number: 2124215-2024-00494
• Device Sequence Number: 20855044
• Product Code: NFA
• UDI-Device Identifier: 08714729470861
• UDI-Public: 08714729470861
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063313
• 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): 02/09/2024

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: 09/13/2025
• Device Model Number: 7576
• Device Catalogue Number: 7576
• Device Lot Number: 0032427881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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