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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 03/10/2021
Event Type  malfunction  
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported that during the procedure of carotid thrombectomy in the patient with moderately tortuous vasculature, a balloon test was performed outside and inside the patient.During preparation the subject balloon was completely inflated and deflated prior to insertion of it inside the patient vasculature and also during the procedure inside the patient's abdominal aorta.Upon reaching the carotid artery the subject balloon guide catheter could not be inflated due to damage/proximal hole to the subject balloon.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
Event Description
It was reported that during the procedure of carotid thrombectomy in the patient with moderately tortuous vasculature, a balloon test was performed outside and inside the patient.During preparation the subject balloon was completely inflated and deflated prior to insertion of it inside the patient vasculature and also during the procedure inside the patient's abdominal aorta.Upon reaching the carotid artery the subject balloon guide catheter could not be inflated due to damage/proximal hole to the subject balloon.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
Manufacturer Narrative
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.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.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.Additional information provided by the customer indicated that the device was prepared as per the dfu, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush set up and maintained throughout the clinical procedure.The patients anatomy was moderately tortuous.The device was not returned for analysis, therefore the reported event of balloon has hole/perforation during use and balloon failed to inflate could not be confirmed.An assignable cause of undeterminable will be assigned to the reported complaint, as, the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.
 
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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 Key11625368
MDR Text Key244395661
Report Number3012931345-2021-00057
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 07/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/16/2022
Device Model Number90495
Device Catalogue Number90495
Device Lot Number0000047213
Was Device Available for Evaluation? No
Date Manufacturer Received06/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
150 CM STIFF GUIDEWIRE (TERUMO); 6FMP CATHETER (UNKNOWN)
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