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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY FLOWGATE2 8F X 85CM; CATHETER, PERCUTANEOUS
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STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY FLOWGATE2 8F X 85CM; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number 90485
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vasoconstriction (2126)
Event Date 12/20/2020
Event Type  Injury  
Manufacturer Narrative
The subject device is unavailable to manufacturer.
 
Event Description
It was reported that the subject flowgate2 balloon catheter was used in the study procedure to treat the clot at the left ica (internal carotid artery)- intracranial-t (bifurcation).Prior procedure, the patient neurological assessment showed the tici (thrombolysis in cerebral infarction score) of 0, national institute of health stroke scale (nihss) of 7 and mrs (modified rankin score) of 0.During the study procedure, the vasospasm occurred which required medical management.The event did not cause neurological deterioration to the patient.Within 24 hours after the procedure showed nihss of 4.The event was resolved at the same day and the patient was discharged approximately 5-7 days post procedure with nihss of 3 and mrs (modified rankin score) of 1.According to the site, the relationship of the vasospasm to the subject device (flowgate2 balloon catheter) and to the procedure.No other information was provided.
 
Event Description
It was reported that the subject flowgate2 balloon catheter was used in the study procedure to treat the clot at the left ica (internal carotid artery)- intracranial-t (bifurcation).Prior procedure, the patient neurological assessment showed the tici (thrombolysis in cerebral infarction score) of 0, national institute of health stroke scale (nihss) of 7 and mrs (modified rankin score) of 0.During the study procedure, the vasospasm occurred which required medical management.The event did not cause neurological deterioration to the patient.Within 24 hours after the procedure showed nihss of 4.The event was resolved at the same day and the patient was discharged approximately 5-7 days post procedure with nihss of 3 and mrs (modified rankin score) of 1.According to the site, the relationship of the vasospasm to the subject device (flowgate2 balloon catheter) and to the procedure.No other information was provided.___________ update information additional information received on 4-feb-2021 indicated that the patient was discharged home on 24 dec 2020, 30- day follow up visit was 12 jan 2021 and current living status is home.In physician¿s opinion, the cause of vasospasm was related to the subject device balloon guide catheter.The medical management was administered in response to the vasospasm as once reperfusion had been established and following the final thrombectomy attempt, 10 mg of ia verapamil was administered through the bgc into the ica.The vasospasm was resolved without clinical consequences to the patient.
 
Manufacturer Narrative
Section b5 executive summary: updated section d catalog # search/ product long description/ catalog #/gim search results/ lot # / gtin: updated.Section f1/h6 health impact code grid - added "no health consequences or impact".
 
Manufacturer Narrative
The device history record review confirms that there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.An assignable cause of anticipated procedural complication will be assigned to this complaint as, a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.
 
Event Description
It was reported that the subject flowgate2 balloon catheter was used in the study procedure to treat the clot at the left ica (internal carotid artery)- intracranial-t (bifurcation).Prior procedure, the patient neurological assessment showed the tici (thrombolysis in cerebral infarction score) of 0, national institute of health stroke scale (nihss) of 7 and mrs (modified rankin score) of 0.During the study procedure, the vasospasm occurred which required medical management.The event did not cause neurological deterioration to the patient.Within 24 hours after the procedure showed nihss of 4.The event was resolved at the same day and the patient was discharged approximately 5-7 days post procedure with nihss of 3 and mrs (modified rankin score) of 1.According to the site, the relationship of the vasospasm to the subject device (flowgate2 balloon catheter) and to the procedure.No other information was provided.Additional information received on 4-feb-2021 indicated that the patient was discharged home on (b)(6) 2020, 30- day follow up visit was (b)(6) 2021 and current living status is home.In physician¿s opinion, the cause of vasospasm was related to the subject device balloon guide catheter.The medical management was administered in response to the vasospasm as once reperfusion had been established and following the final thrombectomy attempt, 10 mg of ia verapamil was administered through the bgc into the ica.The vasospasm was resolved without clinical consequences to the patient.
 
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Brand Name
FLOWGATE2 8F X 85CM
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
4870 west 2100 south
salt lake city UT 84120
MDR Report Key11249299
MDR Text Key229577823
Report Number3012931345-2021-00023
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K153729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 05/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/12/2022
Device Catalogue Number90485
Was Device Available for Evaluation? No
Date Manufacturer Received04/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age24 YR
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