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

Catalog Number	90485
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, when attempting to inflate the subject device, a problem occurred where the outer jacket of the subject device expanded/swelled.Both inflation and deflation took time, but the balloon inflation was possible.The procedure was completed without clinical consequences to the patient.
Event or Problem Description
It was reported that during procedure, when attempting to inflate the subject device, a problem occurred where the outer jacket of the subject device expanded/swelled.Both inflation and deflation took time, but the balloon inflation was possible.The procedure was completed without clinical consequences to the patient.
Additional Manufacturer Narrative
Visual/microscopic inspection of the returned subject device revealed that the balloon catheter was kinked/bent.The balloon catheter shaft outer wall was found to be damaged (expanded/stretched/wrinkled).This was located approximately 5.5cm from the strain relief at the proximal end of the subject device.The balloon catheter tip and the hub were intact.Functional inspection was performed as the 1cc syringe was used to inflate the balloon; however it could not be inflated during the test.The expanded/stretched part of the shaft was inflated.The reported ¿balloon catheter damage¿ was confirmed during the analysis.The reported ¿balloon catheter difficult to inflate¿ and ¿balloon difficult/unable to deflate during use¿ could not be confirmed as the balloon could not be inflated during the test, however the analysis results are consistent with the reported event.The subject device did not meet specifications when received for complaint investigation based on visual inspection.The reported event is covered in the device directions for use (dfu).Also, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the reported event.Additional information received from the customer indicates that the subject device was prepared for use as per the directions for use.There were no anomalies noted to the packaging/device prior to use on the patient.The defect was not noted during preparation, and it is reported that the balloon was successfully inflated during preparation.It was reported that 'when attempted to inflate the balloon, a problem occurred where the outer jacket of the subject device expanded/swelled.Both inflation and deflation took time, but balloon inflation was possible'.In the follow-up responses it was again clarified that this occurred when the subject device was inside the patient.The subject device was returned and the balloon catheter was noted to be kinked/bent in multiple locations along the balloon catheter length.In addition, there were wrinkles noted along the catheter shaft length.The balloon catheter outer layer was noted to be damaged/stretched which is aligned with the information provided in the event description.Given that the balloon was successfully inflated and deflated during preparation and the patients anatomy was not very tortuous, it is probable that the subject device was somehow damaged following initial preparation, causing the reported event.This type of failure occurs when there is a kink or obstruction in the shaft or the balloon is prevented from inflating while fluid is infused to inflate the balloon.If the balloon does not inflate during fluid infusion, the shaft will bulge once the pressure becomes too great.The product is designed so that the balloon material (silicone) will stretch before the shaft material (pebax).An assignable cause of ¿handling damage¿ was assigned to the reported event and analyzed.This complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to handling experienced post preparation damage.

• 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: 21359034
• Report Number: 3012931345-2025-00039
• Device Sequence Number: 12880304
• Product Code: DQY
• UDI-Device Identifier: 00815742004854
• UDI-Public: (01)00815742004854(17)250814(10)0000549041
• 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): 05/02/2025

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: 08/14/2025
• Device Catalogue Number: 90485
• Device Lot Number: 0000549041
• 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: 01/29/2025
• Supplement Date Received by Manufacturer: 04/12/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE (UNKNOWN MANUFACTURER).; MICROCATHETER (UNKNOWN MANUFACTURER).
• Patient Age: 79 YR
• Patient Sex: Male