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

Model Number 44150

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/16/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city-(b)(6).9578588.

Event Description

It was reported that a yellow foreign object was found in the device.The target lesion was in the left internal and common carotid arteries.A 190cm 3.5-5.5 filterwire ez was selected for use.During preparation, it was noted that a yellow foreign object was found in the filter part of the device.The sterility of the device was not compromised but the use was discontinued.The procedure was then completed after replacing the device with the same one.No complications reported.

Manufacturer Narrative

E1.Initial reporter city-(b)(6).Device evaluated by manufacturer: the device was returned for analysis.The wire returned inside the retrieval sheath and the filter bag came back in an undeployed state.The spring tip was bent.A yellow foreign material was observed inside the filter.There is no evidence that the device was used.Microscopic inspection confirmed that the spring tip was bent, and a yellow foreign material was observed.For functional inspection, a sheathing/unsheathing test was performed, and the filter bag could be retracted/deployed normally.Dimensional inspection revealed that the foreign material observed was measured with a tappi chart and the result failed: 1.00mm diameter inside the filter.

Event Description

It was reported that a yellow foreign object was found in the device.The target lesion was in the left internal and common carotid arteries.A 190cm 3.5-5.5 filterwire ez was selected for use.During preparation, it was noted that a yellow foreign object was found in the filter part of the device.The sterility of the device was not compromised but the use was discontinued.The procedure was then completed after replacing the device with the same one.No 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 CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15387434
• MDR Text Key: 299799647
• Report Number: 2124215-2022-32600
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/13/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2023
• Device Model Number: 44150
• Device Catalogue Number: 44150
• Device Lot Number: 0028458116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/08/2022
• Supplement Dates Manufacturer Received: 10/24/2022
• Supplement Dates FDA Received: 11/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2021
• 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