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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/Blood 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.
 
Manufacturer Narrative
The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.H3 other text : device not 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.Additional information received on 03-aug-2021 clarified that the subject balloon would not inflate and was leaking during preparation.No clinical consequences were reported to the patient due to this event.
 
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Brand Name
FLOWGATE2 8F X 95CM
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 Key12222117
MDR Text Key263353136
Report Number3012931345-2021-00120
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00815742004953
UDI-Public00815742004953
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
Report Date 08/30/2021
1 Device was Involved in the Event
1 Patient was 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
Date Manufacturer Received08/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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