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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 Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/22/2021
Event Type  malfunction  
Event Description
It was reported that during procedure upon placing the balloon (subject device) in the blood vessel and attempting to inflate it, the physician noticed that the balloon (subject device) did not inflate and when he removed it he found that it was broken.The physician indicates that it may have perforated in the passage through an atheromatous plaque that the patient had.The procedure was completed successfully.No clinical consequences were reported due to this event.
 
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported that during procedure upon placing the balloon (subject device) in the blood vessel and attempting to inflate it, the physician noticed that the balloon (subject device) did not inflate and when he removed it he found that it was broken.The physician indicates that it may have perforated in the passage through an atheromatous plaque that the patient had.The procedure was completed successfully.No clinical consequences were reported due to this event.
 
Manufacturer Narrative
D4 lot # - corrected from 59033 to 0000059033.There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported events were unable to be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.He 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.As per the additional information, the device was prepared for use as per the directions for use, the device was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush was set up and maintained throughout the clinical procedure and the patient¿s anatomy was moderately tortuous.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 the reported 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 Key12849621
MDR Text Key281067058
Report Number3012931345-2021-00194
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00815742004953
UDI-Public00815742004953
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
K153729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/17/2023
Device Model Number90495
Device Catalogue Number90495
Device Lot Number0000059033
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/18/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
REBAR18 (NON- STRYKER MANUFACTURER); SOLITAIRE (NON- STRYKER MANUFACTURER); TRANSEND EX 0.014 (STRYKER MANUFACTURER)
Patient Age78 YR
Patient SexFemale
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