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

Model Number H749201001900

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 10/29/2020

Event Type  malfunction  

Event Description

Elderly male with history of coronary artery disease, hypertension and new onset chest pain.When using the boston scientific filterwire, the basket would not deploy.No known harm to patient.

• 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
• MDR Report Key: 10835572
• MDR Text Key: 216109946
• Report Number: 10835572
• Device Sequence Number: 1
• Product Code: NFA
• UDI-Device Identifier: 08714729470854
• UDI-Public: (01)08714729470854(17)220310(10)25336700
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H749201001900
• Device Lot Number: 25336700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/05/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Weight: 109