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

Model Number	90495
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 1 of 2 reports.The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that during procedure, the subject balloon device burst.No clinical consequences were reported to the patient due to this event.No other information was provided.
Additional Manufacturer Narrative
D4 expiration date - added.D9/h3 product available to stryker ¿ updated.D9 returned to manufacturer on - updated.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.H4 manufacturing date ¿ added.There are controls in the manufacturing process to ensure the product met specifications upon release.Visual and microscopic examination of the returned subject balloon catheter device found to be kinked/bent in multiply areas and the balloon was burst/ruptured.A functional inspection could not be performed due to condition of the subject balloon catheter device.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.It was reported that when using the flowgate product was burst.Additional information states that the balloons were inflated to nominal pressure with a 1ml syringe, there was no leakage noted during preparation of the balloons and the patient¿s anatomy was noted to be moderately tortuous.The subject balloon catheter device was returned and the balloon catheter shaft was noted to be kinked in numerous locations and the balloon was noted to be burst/ruptured, confirming the reported event.It is probable that the balloon was damaged during the clinical procedure causing the reported event.An assignable cause of procedural factors will be assigned to the reported and analysed ¿ balloon burst/ruptured during use¿.It is probable that the balloon catheter shaft was kinked at some point after the event due to handling of the device, therefore an assignable cause of handling damage will be assigned to the analysed ¿balloon catheter kinked/bent¿.
Event or Problem Description
It was reported that during procedure, the subject balloon device burst.No clinical consequences were reported to the patient due to this event.No other information was provided.

• 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: 15041375
• Report Number: 3012931345-2022-00146
• Device Sequence Number: 12494991
• Product Code: DQY
• UDI-Device Identifier: 00815742004953
• UDI-Public: 00815742004953
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2022

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: 11/18/2023
• Device Model Number: 90495
• Device Catalogue Number: 90495
• Device Lot Number: 0000091871
• 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: 07/07/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2021
• 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