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	03/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device fracture occurred.The patient underwent stent implantation for carotid artery.A 300 cm filterwire ez was selected for use.During the procedure, after placing an 8f short sheath, a pt2 guidewire support was used at the lesion at the left carotid artery.However, when the device entered the delivery catheter, it was noted that the avulsion part of the delivery sheath was fractured.The procedure was then completed with another of same device.No complications were reported and the patient was stable post-procedure.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the wire was returned inside the retrieval sheath and the filter bag came back in deployed state.Also, the retrieval sheath and a package with accessories were returned.Sheathing/unsheathing could not be performed, since the wire was exposed through the delivery sheath, moreover the spring tip was bent and stretched.
Event or Problem Description
It was reported that a device fracture occurred.The patient underwent stent implantation for carotid artery.A 300 cm filterwire ez was selected for use.During the procedure, after placing an 8f short sheath, a pt2 guidewire support was used at the lesion at the left carotid artery.However, when the device entered the delivery catheter, it was noted that the avulsion part of the delivery sheath was fractured.The procedure was then completed with another of same device.No complications were reported and the 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; 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: 19084931
• Report Number: 2124215-2024-19052
• Device Sequence Number: 7641240
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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: 09/28/2024
• Device Model Number: 7576
• Device Catalogue Number: 7576
• Device Lot Number: 0030245154
• 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: 03/20/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INTRODUCER SHEATH - 8F SHORT SHEATH; INTRODUCER SHEATH - 8F SHORT SHEATH; SUPPORT GUIDEWIRE - PT2 GUIDEWIRE; SUPPORT GUIDEWIRE - PT2 GUIDEWIRE
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 90 KG