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

Model Number	7576
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the recovery sheath could not be retracted.The 50% stenosed target lesion was located in the mildly tortuous and mildly calcified carotid artery.A 300cm filterwire ez was selected for use.During the procedure, it was noted that the thrombus protection recovery sheath got damage and could not be recaptured.The device was completely removed from the patient.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.It was observed the wire returned inside the delivery sheath and the filter bag came back in a deployed state.The wire was exposed through the sheath slit.Under microscopic inspection, it was observed that the spring tip was bent and stretched.The retrieval sheath was also returned and no damages or issues were observed.The pouch was returned, and it was observed that the pouch information matches with the complaint information.During functional inspection, the sheathing and unsheathing test could not be performed, because the wire was exposed through the retrieval sheath.
Event or Problem Description
It was reported that the recovery sheath could not be retracted.The 50% stenosed target lesion was located in the mildly tortuous and mildly calcified carotid artery.A 300cm filterwire ez was selected for use.During the procedure, it was noted that the thrombus protection recovery sheath got damage and could not be recaptured.The device was completely removed from the patient.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16368191
• Report Number: 2124215-2023-03931
• Device Sequence Number: 6813740
• Product Code: NFA
• UDI-Device Identifier: 08714729470861
• UDI-Public: 08714729470861
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2023

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: 05/22/2024
• Device Model Number: 7576
• Device Catalogue Number: 7576
• Device Lot Number: 0029454096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 60 KG