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 or Delayed Positioning (1157); Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sheath was torn, and tip was detached.A 300 cm filterwire ez was selected for use in the carotid artery.The filter was operated as required outside the body, and after priming, it was entered into the delivery sheath and delivered into the patient's body.However, when the filter was advanced, the filter could not be released, and the device could not be pushed or pulled.The physician used a retrieval sheath up to the internal carotid to withdraw the filter, but it was found that the delivery sheath had been torn, and the physician did not avulsion the delivery sheath throughout.After further observation, the filter was slightly shaped, and the tip was already damaged by detachment.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post-procedure.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).E1 - initial reporter address 1: (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the complaint device was received for product analysis.Visual inspection of the device was performed and revealed that the filter bag came back in undeployed state.The spring tip was kinked and stretched, and the wire was exposed through the sheath slit.No more damages were observed during visual inspection.During functional inspection, sheathing/unsheathing test could not be performed due to the wire was exposed through the sheath slit.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the sheath was torn, and tip was detached.A 300 cm filterwire ez was selected for use in the carotid artery.The filter was operated as required outside the body, and after priming, it was entered into the delivery sheath and delivered into the patient's body.However, when the filter was advanced, the filter could not be released, and the device could not be pushed or pulled.The physician used a retrieval sheath up to the internal carotid to withdraw the filter, but it was found that the delivery sheath had been torn, and the physician did not avulsion the delivery sheath throughout.After further observation, the filter was slightly shaped, and the tip was already damaged by detachment.The procedure was completed with another of the 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: 18302714
• Report Number: 2124215-2023-68680
• Device Sequence Number: 3177184
• 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): 02/02/2024

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: 02/21/2025
• Device Model Number: 7576
• Device Catalogue Number: 7576
• Device Lot Number: 0031102085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/24/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2023
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 70 KG