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

Model Number 44150

Device Problem Failure to Advance (2524)

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

Event Date 12/05/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: the wire was returned inside the delivery sheath.Visual and microscopic inspection observed that the spring tip was bent and detached.The filter bag came back in an undeployed state.No more damages were observed.

Event Description

Reportable based on device analysis completed on 07aug2023.It was reported that crossing difficulties were encountered.The 85% stenosed target lesion was located in the severely tortuous and mildly calcified lesion.A 190 cm filterwire ez was selected for use.During the procedure, the device was not able to cross the lesion.The device was removed and the procedure was completed with a different device.No complications were reported and the patient was stable.However, device analysis revealed tip detachment.

• 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 DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17652487
• MDR Text Key: 322436479
• Report Number: 2124215-2023-45098
• Device Sequence Number: 1
• Product Code: NFA
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2024
• Device Model Number: 44150
• Device Catalogue Number: 44150
• Device Lot Number: 0028855540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2022
• 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
• Patient Age: 57 YR
• Patient Sex: Male