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

Model Number	90495
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an endovascular procedure in a patient with internal carotid artery aneurysm, the subject balloon was only partially inflated during use and when removed from patient vasculature, it was found to be leaking.The procedure was completed successfully by replacing the subject device.No clinical consequences were reported to the patient due to this event.
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 internal carotid artery aneurysm, the subject balloon was only partially inflated during use and when removed from patient vasculature, it was found to be leaking.The procedure was completed successfully by replacing the subject device.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The device was received and the reported lot number was confirmed from the packaging label.During visual/microscopic inspection, the balloon catheter was found to be kinked/bent.Functional inspection, balloon difficult to inflate functional test ¿ fail.The balloon could not be inflated due to leakage.Balloon leaked functional test ¿ fail.At attempt was taken to inflate the balloon; however, the balloon could not be inflated due to leakage.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 events were confirmed based on the analysis.The device did not meet specifications when received for complaint investigation based on the visual inspection.It was reported that prepared and delivered the flowgate2 balloon to the placed and dilated it.However only part of the balloon was inflated and the rest was not inflated and the balloon could not stop the blood flow.As per the additional information, 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 was set up and maintained throughout the clinical procedure and the patients anatomy was moderately tortuous.The device was not inflated over nominal pressure or excessive pressure used, the balloon was able to be successfully inflated during preparation and there was no leakage noted during preparation.The device was returned and there was kinking noted to the balloon catheter, during the inflation attempt the balloon could not be inflated due to a leak to the balloon.It is probable that the device was damaged during the clinical procedure, causing the reported events.An assignable cause of procedural factors will be assigned to the reported and analyzed events of 'balloon leaked during use' and 'balloon difficult to inflate' and to the analyzed event of 'balloon catheter kinked/bent', as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

• 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: 15418719
• Report Number: 3012931345-2022-00173
• Device Sequence Number: 19472009
• Product Code: DQY
• UDI-Device Identifier: 00815742004953
• UDI-Public: 00815742004953
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/26/2022

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: 02/19/2023
• Device Model Number: 90495
• Device Catalogue Number: 90495
• Device Lot Number: 0000059134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 11/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 8F FEMORAL ARTERY PUNCTURE SHEATH (UNKNOWN); CATALYST6 CATHETER (STRYKER)
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Race: Asian