MAUDE Adverse Event Report: CONCENTRIC MEDICAL FLOWGATE2 8F X 85CM; CATHETER, PERCUTANEOUS

Model Number	90485
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem 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.
Additional 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.

• Brand Name: FLOWGATE2 8F X 85CM
• Common Device Name: 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 Key: 15041537
• Report Number: 0002954917-2022-00001
• Device Sequence Number: 5450942
• Product Code: DQY
• UDI-Device Identifier: 00815742004854
• UDI-Public: 00815742004854
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2023
• Device Model Number: 90485
• Device Catalogue Number: 90485
• Device Lot Number: 65652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown