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

Model Number 44150

Device Problem Difficult to Remove (1528)

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

Event Date 10/14/2021

Event Type  malfunction  

Event Description

It was reported that the filter failed to be retrieved.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified internal and common carotid artery.A 3.5-5.5 190cm filterwire ez was selected for use.During the procedure, the filterwire was inserted however it did not come out from the wire port of the retrieval sheath when retracted.Consequently, a new filterwire's retrieval sheath was needed to retrieve the first wire as the filter failed to be retrieved with the first retrieval sheath.The device was removed from the patient's body.There were no patient complications reported.

Manufacturer Narrative

Initial reporter name and address: (b)(6).

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6).E1.Initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Unit returned with its original pouch batch 27828066, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The filterwire was not returned inside the delivery sheath, only, the retrieval and delivery sheath were returned and no issues or anomalies were noted.No other issues or anomalies were observed.

Event Description

It was reported that the filter failed to be retrieved.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified internal and common carotid artery.A 3.5-5.5 190cm filterwire ez was selected for use.During the procedure, the filterwire was inserted however it did not come out from the wire port of the retrieval sheath when retracted.Consequently, a new filterwire's retrieval sheath was needed to retrieve the first wire as the filter failed to be retrieved with the first retrieval sheath.The device was removed from the patient's body.There were no patient complications 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: 12800772
• MDR Text Key: 280897997
• Report Number: 2134265-2021-14158
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2023
• Device Model Number: 44150
• Device Catalogue Number: 44150
• Device Lot Number: 0027828066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2021
• 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