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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 Problems Stroke/CVA (1770); Death (1802); Embolus (1830)
Event Date 12/12/2019
Event Type  Injury  
Manufacturer Narrative

The subject device is unavailable to manufacturer.

 
Event Description

It was reported that during procedure, the subject retrieval device was used to remove the clot from the femoral middle cerebral artery (mca) in left m2 segment. Ent (embolization to new territory) was observed in left anterior cerebral artery (aca- a2) and the ent was not treated. Pre procedure the patient was assessed having a thrombolysis in cerebral infarction score (tici) of 0. No other information was provided.

 
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Brand NameFLOWGATE2 8F X 85CM
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
4870 west 2100 south
salt lake city UT 84120
Manufacturer (Section G)
STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
4870 west 2100 south
salt lake city UT 84120
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key9975532
MDR Text Key188658612
Report Number3012931345-2020-00064
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK153729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Remedial Action Inspection
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/01/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/17/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number90485
Device LOT Number0000024633
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/17/2020 Patient Sequence Number: 1
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