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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 Problem Deflation Problem (1149)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/31/2020
Event Type  malfunction  
Manufacturer Narrative
The subject device not returned.
 
Event Description
It was reported that during the procedure, the subject balloon guide catheter was inflated without any issues; however, it took a while to deflate.The physician reported a minimum time frame of 5 minutes for the deflation.No clinical consequences reported due to this event.
 
Manufacturer Narrative
D4: expiration date - added.H4: manufacturing date ¿ added.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.Visual and functional testing could not be performed since the device was not returned for investigation.The reported event is covered in the device direction 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.Additional information provided by the customer indicated that the device was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, and the anatomy was moderately tortuous.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable was assigned to this complaint.Nc 2532683 has been raised to further investigate balloon deflation failures during preparation and use.No other escalation is recommended or required at this time.
 
Event Description
It was reported that during the procedure, the subject balloon guide catheter was inflated without any issues; however, it took a while to deflate.The physician reported a minimum time frame of 5 minutes for the deflation.No clinical consequences reported 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 Key10446688
MDR Text Key204173345
Report Number3012931345-2020-00119
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 11/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/04/2021
Device Model Number90495
Device Catalogue Number90495
Device Lot Number0000030892
Was Device Available for Evaluation? No
Date Manufacturer Received11/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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