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

Model Number 7576

Device Problems Failure to Advance (2524); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/02/2024

Event Type  malfunction  

Manufacturer Narrative

E1 - initial reporter address 1: no.(b)(6).

Event Description

It was reported that the filterwire broke out of the delivery sheath.The more than 90% stenosed target lesion was located in the internal carotid artery.During the procedure, an 8f mach1 guiding was exchanged and placed at the ostial of internal carotid artery.The guidewire was advanced to the cavernous sinus in the internal carotid artery, and along the guidewire a 2*20 coyote balloon was used for dilation.After the balloon and the guidewire was removed, a 190 cm filterwire ez was selected for carotid artery stenting.However, the filterwire could not cross the lesion after repeated attempts, the delivery system kinked, and the guidewire broke out of the delivery sheath.The device was pulled out completely and was replaced with another of the same filterwire.A sterling 5*30 balloon was placed along the filter guidewire, which was dilated, and when it was withdrawn, angiography was performed.Then, a 9*30 wallstent stent was implanted along the filterwire guidewire and angiography was performed again.The procedure was completed successfully.No complications were reported, and the patient was stable post-procedure.

• Brand Name: FILTERWIRE EZ
• Type of Device: 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: 18587598
• MDR Text Key: 334780305
• Report Number: 2124215-2024-01506
• Device Sequence Number: 1
• Product Code: NFA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K063313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7576
• Device Catalogue Number: 7576
• Device Lot Number: 0031855337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2023
• 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
• Treatment: BALLOON CATHETER - 2*20 COYOTE; BALLOON CATHETER - STERLING 5*30 BALLOON; GUIDE CATHETER - 8F MACH1; STENT - 9*30 WALLSTENT
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 65 KG