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	11/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure, the subject balloon ruptured inside the patient's anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No further information is available.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿ updated.H3 summary attached - updated.D4 expiration date - added.D10 product available to stryker ¿ updated.D10 returned to manufacturer on ¿ updated there are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the balloon catheter was found to be kinked/bent.The balloon was found to be damaged/ruptured.During functional inspection, balloon burst/ruptured functional test ¿ balloon inflation was not attempted due to condition of the device.Balloon damage was confirmed during visual inspection.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 event was confirmed during analysis.The device failed to meet specification when received, due to the damage noted.It was reported that during the last intervention the balloon ruptured.Additional information states that the device was prepared for use as per the directions for use, the device 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 patient¿s anatomy was moderately tortuous.The device was returned, and the balloon was noted to be damaged/ruptured, confirming the reported event, the balloon catheter shaft was also kinked.It is probable that the device was damaged during advancement through the patient¿s anatomy causing the reported event.An assignable cause of procedural factors will be assigned to the as reported and as analyzed ¿balloon burst/ruptured during use¿ and to the as analyzed ¿ 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.
Event or Problem Description
It was reported that during the procedure, the subject balloon ruptured inside the patient's anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No further information is available.

• 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: 15975104
• Report Number: 3012931345-2022-00223
• Device Sequence Number: 20563520
• Product Code: DQY
• UDI-Device Identifier: 00815742004953
• UDI-Public: 00815742004953
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 03/17/2023

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: 04/16/2024
• Device Model Number: 90495
• Device Catalogue Number: 90495
• Device Lot Number: 0000125096
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2022
• 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