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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 Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/10/2022
Event Type  malfunction  
Event Description
It was reported that during the procedure the balloon (subject device) was unable to deflate during use.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
Manufacturer Narrative
The device is not available to the manufacturer.
 
Manufacturer Narrative
The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Due to the automated dhr system there are controls in the manufacturing process to ensure the product met specifications upon release.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.The reported event could not be confirmed, and it cannot be confirmed if the device met specification, as the device was not returned.It was reported that the balloon was not deflating and it had to be pulled back all the way to the sheath.Additional information received states that the device was prepped as per the dfu, no anomalies were noted to the device during initial inspection and preparation continuous flush was maintained for the duration of the procedure, the patient¿s anatomy was averagely tortuous and the balloon was able to be successfully inflated during preparation.As the device was not returned and a review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of undeterminable will be assigned to this complaint.
 
Event Description
It was reported that during the procedure the balloon (subject device) was unable to deflate during use.The procedure was completed successfully.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
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 Key13453387
MDR Text Key285063876
Report Number3012931345-2022-00020
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00815742004953
UDI-Public00815742004953
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K153729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/03/2023
Device Model Number90495
Device Catalogue Number90495
Device Lot Number0000060222
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/10/2022
Initial Date FDA Received02/04/2022
Supplement Dates Manufacturer Received04/21/2022
Supplement Dates FDA Received05/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/03/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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