MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY FLOWGATE2 8F X 95CM; CATHETER, PERCUTANEOUS

Catalog Number	90495
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that although the balloon deflated normally during a test inflation outside the body, it failed to deflate inside the patient during the procedure.Even after replacing the syringe, the balloon still did not deflate and was eventually deflated by forcefully pulling it from the internal carotid artery to the common carotid artery.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
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.Addition information received indicated that the device was prepared for use as per the directions for use.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.The patients anatomy was described as 'average tortuosity'.It was reported that 'although the balloon was deflated during the test inflation at the outside of the body, it did not deflate inside the patient's body during the procedure.The balloon did not deflate even after the syringe was replaced, so it was deflated when it was forcefully pulled from the internal carotid artery to the common carotid artery, then the procedure was completed successfully'.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 the reported for 'balloon difficult/unable to deflate during use.'.
Event or Problem Description
It was reported that although the balloon deflated normally during a test inflation outside the body, it failed to deflate inside the patient during the procedure.Even after replacing the syringe, the balloon still did not deflate and was eventually deflated by forcefully pulling it from the internal carotid artery to the common carotid artery.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: FLOWGATE2 8F X 95CM
• 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: 20728029
• Report Number: 3012931345-2024-00202
• Device Sequence Number: 12886676
• Product Code: DQY
• UDI-Device Identifier: 00815742004953
• UDI-Public: (01)00815742004953(17)250729(10)0000538345
• 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): 01/28/2025

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: 07/29/2025
• Device Catalogue Number: 90495
• Device Lot Number: 0000538345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2023
• 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