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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 95CM CATHETER, PERCUTANEOUS

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STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY FLOWGATE2 8F X 95CM CATHETER, PERCUTANEOUS Back to Search Results
Model Number 90495
Device Problems Fluid Leak (1250); Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/25/2021
Event Type  Malfunction  
Manufacturer Narrative

Device not yet received for evaluation.

 
Event Description

It was reported during the procedure the balloon (subject device) would not inflate and it was leaking. The physician replaced the subject device and completed the procedure without clinical consequences to the patient due to this event.

 
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Brand NameFLOWGATE2 8F X 95CM
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 Key12222117
MDR Text Key263353136
Report Number3012931345-2021-00120
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeTU
PMA/PMN NumberK153729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/30/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/23/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number90495
Device Catalogue Number90495
Device LOT Number0000053120
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 Received08/03/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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