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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCENTRIC MEDICAL FLOWGATE2 8F X 85CM; CATHETER, PERCUTANEOUS
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CONCENTRIC MEDICAL FLOWGATE2 8F X 85CM; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 90485
Device Problem Deflation Problem (1149)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/24/2022
Event Type  malfunction  
Event Description
It was reported that during an endovascular procedure in a patient with carotid artery stenosis, the subject balloon failed to deflate inside the patient vasculature.When it was attempted to be removed, it gradually deflated.The procedure was completed.There were no reports of clinical consequences to the patient.No further information is available.
 
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported that during an endovascular procedure in a patient with carotid artery stenosis, the subject balloon failed to deflate inside the patient vasculature.When it was attempted to be removed, it gradually deflated.The procedure was completed.There were no reports of clinical consequences to the patient.No further information is available.
 
Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual testing as well as functional 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.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.It was reported that an attempt was made to deflate the balloon inside the patient's anatomy, but was unable to do so.The balloon gradually deflated when the catheter was attempted to be removed as it was.Additional information states that the balloon inflated successfully during preparation, a 1cc syringe was used to inflate the balloon, 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 set up and maintained throughout the clinical procedure and the patients anatomy was very meandering.As the device was not returned and analysis of all of the 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 event of 'balloon difficult/unable to deflate during use'.H3 other text : the device is not available to the manufacturer.
 
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Brand Name
FLOWGATE2 8F X 85CM
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
CONCENTRIC MEDICAL
301 east evelyn
mountain view CA 94041
Manufacturer (Section G)
CONCENTRIC MEDICAL
301 east evelyn
mountain view CA 94041
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key15041537
MDR Text Key304605789
Report Number0002954917-2022-00001
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00815742004854
UDI-Public00815742004854
Combination Product (y/n)N
Reporter Country CodeJA
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 10/17/2022
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 Date06/11/2023
Device Model Number90485
Device Catalogue Number90485
Device Lot Number65652
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/24/2022
Initial Date FDA Received07/18/2022
Supplement Dates Manufacturer Received09/22/2022
Supplement Dates FDA Received10/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/12/2021
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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