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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FILTERWIRE EZ; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
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BOSTON SCIENTIFIC CORPORATION FILTERWIRE EZ; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE Back to Search Results
Model Number 44150
Device Problem Break (1069)
Patient Problems Stroke/CVA (1770); Embolism (1829); Hemorrhage, Cerebral (1889); Paralysis (1997); Device Embedded In Tissue or Plaque (3165)
Event Date 10/15/2018
Event Type  Injury  
Event Description
It was reported that the tip broke and embolized into the cranium.The target lesion was located in a severely tortuous left internal carotid artery.A 190cm filterwire ez was selected for use.During procedure, an 8fr non- bsc guide catheter and filterwire were used to advanced into the lesion; filter was deployed.Two 10x 40 non-bsc drug eluting stents were then placed after pre-dilation.The filterwire was then retrieved and removed smoothly without any resistance from the patient's body.However, upon checking the lesion under angiography; it was noted the tip of the retrieval sheath flowed from common carotid artery before the lesion to peripheral.It was thought there was issue at the section proximal to the placed stent.The tip part was tried to retrieve after that, but since it exceeded the peripheral, it caused bleeding.The procedure was ended with the tip remained as it was.As per physician's opinion on what could have cause the tip detachment, maybe there was a defect on the strength of the product, retrieval sheath got damaged by getting caught with the edge of the tip of 8fr non- bsc guide catheter due to bad angle or the retrieval sheath got damaged by the valve of push type y-connector.The condition of the patient currently is serious, and due to cerebral infarction, which was caused by the broken catheter tip part and cerebral hemorrhage that occurred when trying to retrieve that broken part, a wide range of left brain infarction occurred; symptoms includes aphasia and right body paralysis.No further patient complications reported.
 
Manufacturer Narrative
Device eval by manufacturer: the device was returned for analysis.Visual inspection revealed that the guidewire has the tip of the retrieval sheath partially detached and the wire is kinked in the proximal section.Dimensional inspection of all outer diameters were performed and were within specifications.Evaluation conclusion codes was updated from adverse event related to procedure to cause not established.
 
Event Description
It was reported that the tip broke and embolized into the cranium.The target lesion was located in a severely tortuous left internal carotid artery.A 190cm filterwire ez was selected for use.During procedure, an 8fr non- bsc guide catheter and filterwire were used to advanced into the lesion; filter was deployed.Two 10x 40 non-bsc drug eluting stents were then placed after pre-dilation.The filterwire was then retrieved and removed smoothly without any resistance from the patient's body.However, upon checking the lesion under angiography; it was noted the tip of the retrieval sheath flowed from common carotid artery before the lesion to peripheral.It was thought there was issue at the section proximal to the placed stent.The tip part was tried to retrieve after that, but since it exceeded the peripheral, it caused bleeding.The procedure was ended with the tip remained as it was.As per physician's opinion on what could have cause the tip detachment, maybe there was a defect on the strength of the product, retrieval sheath got damaged by getting caught with the edge of the tip of 8fr non- bsc guide catheter due to bad angle or the retrieval sheath got damaged by the valve of push type y-connector.The condition of the patient currently is serious, and due to cerebral infarction, which was caused by the broken catheter tip part and cerebral hemorrhage that occurred when trying to retrieve that broken part, a wide range of left brain infarction occurred; symptoms includes aphasia and right body paralysis.No further patient complications reported.
 
Event Description
It was reported that the tip broke and embolized into the cranium.The target lesion was located in a severely tortuous left internal carotid artery.A 190cm filterwire ez was selected for use.During procedure, an 8fr non- bsc guide catheter and filterwire were used to advanced into the lesion; filter was deployed.Two 10x 40 non-bsc drug eluting stents were then placed after pre-dilation.The filterwire was then retrieved and removed smoothly without any resistance from the patient's body.However, upon checking the lesion under angiography; it was noted the tip of the retrieval sheath flowed from common carotid artery before the lesion to peripheral.It was thought there was issue at the section proximal to the placed stent.The tip part was tried to retrieve after that, but since it exceeded the peripheral, it caused bleeding.The procedure was ended with the tip remained as it was.As per physician's opinion on what could have cause the tip detachment, maybe there was a defect on the strength of the product, retrieval sheath got damaged by getting caught with the edge of the tip of 8fr non- bsc guide catheter due to bad angle or the retrieval sheath got damaged by the valve of push type y-connector.The condition of the patient currently is serious, and due to cerebral infarction, which was caused by the broken catheter tip part and cerebral hemorrhage that occurred when trying to retrieve that broken part, a wide range of left brain infarction occurred; symptoms includes aphasia and right body paralysis.No further patient complications reported.The device was returned for analysis.Visual inspection revealed that the guidewire has the tip of the retrieval sheath partially detached and the wire is kinked in the proximal section.Dimensional inspection of all outer diameters were performed and were within specifications.
 
Manufacturer Narrative
This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/19/2018 04:02 pm ct.The report number is being corrected from: 2134265-2018-64549 to: 2134265-2018-62734.
 
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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
MDR Report Key8055358
MDR Text Key126680110
Report Number2134265-2018-62734
Device Sequence Number1
Product Code NTE
Combination Product (y/n)N
PMA/PMN Number
K063313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 01/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/12/2020
Device Model Number44150
Device Catalogue Number44150
Device Lot Number0022244313
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2018
Date Manufacturer Received01/09/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
Patient Age72 YR
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