MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY FLOWGATE2 8F X 85CM; CATHETER, PERCUTANEOUS

Catalog Number	90485
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, when the subject balloon guide catheter was inserted into the patient's body and attempted to inflate the balloon at ica; however, the subject balloon did not inflate.When the device was removed from the body, the middle part of the subject balloon was found to be leaked.The balloon was replaced, and the procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not 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 'there were no issues during preparation.When the subject balloon guide catheter was inserted into the patient's body and attempted to inflate the balloon at internal carotid artery (ica); however, the balloon did not inflate.The procedure was successfully completed performing carotid artery stenting (cas).When the device was removed from the body, the middle part of the balloon was found to be leaked.When the device was removed from the body, the leak was found from the middle part of the balloon.In the follow-up good faith efforts (gfe) responses, it was noted that the balloon was successfully inflated during preparation.Additional information provided by the customer indicated that the device was prepared as per the directions for use (dfu).There was no damage noted to the packaging prior to opening the packaging and the device was confirmed to be in good condition prior to use on the patient.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during the procedure, when the subject balloon guide catheter was inserted into the patient's body and attempted to inflate the balloon at ica; however, the subject balloon did not inflate.When the device was removed from the body, the middle part of the subject balloon was found to be leaked.The balloon was replaced, and the procedure was completed successfully with no clinical consequences to the patient.

• Brand Name: FLOWGATE2 8F X 85CM
• Common Device Name: 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 Key: 23475886
• Report Number: 3012931345-2025-00177
• Device Sequence Number: 10558378
• Product Code: DQY
• UDI-Device Identifier: 00815742004854
• UDI-Public: (01)00815742004854(17)260201(10)0000617151
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: 02/01/2026
• Device Catalogue Number: 90485
• Device Lot Number: 0000617151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2024
• 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