MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FILTERWIRE EZ; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number 44150

Device Problem Material Integrity Problem (2978)

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

Event Date 07/30/2021

Event Type  malfunction  

Event Description

It was reported that the delivery sheath was separated upon removal.The 70% stenosed target lesion was located in the moderately tortuous and mildly calcified common carotid artery.A filter wire ez has been selected for use.During deployment, the filter wire has crossed the stenosed area.However, resistance was felt when the sheath touched the y-connector that was attached into the guiding catheter.When the device was pulled strongly, the delivery sheath got separated.The separated sheath remained on the filter wire so the subsequent procedure could not be performed.The filter wire was then removed together with the separated delivery sheath.The procedure was completed with another of same device.No complications reported and patient was in good health soon after the surgery.

• Brand Name: FILTERWIRE EZ
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12336909
• MDR Text Key: 267080648
• Report Number: 2134265-2021-10291
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: 44150
• Device Catalogue Number: 44150
• Device Lot Number: 0026892036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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: 76 YR