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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FILTERWIRE EZ; TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION
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BOSTON SCIENTIFIC CORPORATION FILTERWIRE EZ; TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION Back to Search Results
Model Number 7576
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/23/2024
Event Type  malfunction  
Event Description
It was reported that the tip detachment occurred.The stenosed target lesion was located in the left internal carotid artery.A 190 cm filterwire ez was selected for use.During preparation, it was noted that the guidewire at the tip of the filterwire separated and could not be used.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
 
Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: the wire returned inside the delivery sheath and the filter bag came back in deployed state.Also, the retreival sheath was returned.The wire was exposed through the delivery sheath.The spring tip was bent and stretched.No other issues were identified during the product analysis.
 
Event Description
It was reported that the tip detachment occurred.The stenosed target lesion was located in the left internal carotid artery.A 190 cm filterwire ez was selected for use.During preparation, it was noted that the guidewire at the tip of the filterwire separated and could not be used.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
 
Event Description
It was reported that the tip detachment occurred.The stenosed target lesion was located in the left internal carotid artery.A 190 cm filterwire ez was selected for use.During preparation, it was noted that the guidewire at the tip of the filterwire separated and could not be used.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
 
Manufacturer Narrative
B3 - updated date of event from 01/23/2024 to 01/09/2024.E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: the wire returned inside the delivery sheath and the filter bag came back in deployed state.Also, the retrieval sheath was returned.The wire was exposed through the delivery sheath.The spring tip was bent and stretched.No other issues were identified during the product analysis.The reported damaged not was observed.
 
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Brand Name
FILTERWIRE EZ
Type of Device
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 Key18715051
MDR Text Key336240593
Report Number2124215-2024-04459
Device Sequence Number1
Product Code NFA
UDI-Device Identifier08714729470854
UDI-Public08714729470854
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K063313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7576
Device Catalogue Number7576
Device Lot Number0031989958
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/04/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age68 YR
Patient SexMale
Patient Weight75 KG
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