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

Model Number 44150

Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919); Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/27/2021

Event Type  Injury  

Event Description

It was reported that the filterwire broke and remained inside the patient's body.Vascular access was obtained via the common femoral artery.The 90% stenosed target lesion was located in the mildly tortuous internal carotid artery.During the procedure, a 190cm filterwire was positioned in the target lesion along with a non-boston scientific 0.014 guidewire.After pre-dilation, a non-boston scientific stent was delivered and deployed along with the non-boston scientific guidewire.After dilation, the retrieval catheter was inserted, but was caught on the proximal portion of the stent and could not advance any further, leaving the filterwire on the outside of the stent.The retrieval catheter was retracted, and a new filterwire was opened.The retrieval catheter was inserted again, and an attempt was made to retract the filterwire, but was unsuccessful and broke in the process.The filter part of this filterwire caught on the distal edge of the stent.The procedure was completed leaving the filter portion of the wire inside the patient's body.No further patient injuries were reported.

• 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: 12374576
• MDR Text Key: 268372717
• Report Number: 2134265-2021-10802
• 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: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2023
• Device Model Number: 44150
• Device Catalogue Number: 44150
• Device Lot Number: 0026578019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2021
• 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
• Treatment: GUIDEWIRE - CHIKAI; STENT - PRECISE
• Patient Outcome(s): Other