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

Model Number 90485

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2022

Event Type  malfunction  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that during the procedure, the subject balloon was unable to deflate which resulted in the catheter falling out of the internal carotid artery back into the aorta.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

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 device was returned together with the extension tubing.The balloon catheter was found to be kinked/bent in multiple areas.The balloon was found to be intact.During functional inspection, balloon difficult/unable to deflate functional test passed.The balloon could be inflated and deflated without difficulties.The test was repeated a few times.The reported balloon difficult/unable to deflate was not confirmed during the analysis.The reported unexpected movement of device could not be confirmed during the analysis as the event is procedure/patient related.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 could not be confirmed based on the device analysis.The device failed to meet specification when returned, based on the damage noted.It was reported that guide catheter was faulty balloon would not deflate which resulted in the catheter falling out of selected vessel, which was the internal carotid back into the aorta, there was no additional information available.The device was returned, and the balloon catheter was noted to be kinked, the balloon was able to be inflated and deflated a few times without difficulty.As the balloon catheter was able to be inflated and deflated during analysis without difficulty, and the bending noted to the device is not likely to have contributed to the deflation of the balloon.A review of the available information fails to indicate an assignable cause for the balloon failure to deflate, therefore an assignable cause of undeterminable will be assigned to the as reported ¿balloon difficult/unable to deflate during use¿ and ¿unexpected movement of device¿.It is probable that the balloon catheter was bent during use, therefore an assignable cause of procedural factors will be assigned to as analyzed ¿balloon catheter kinked/bent¿.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

Event Description

It was reported that during the procedure, the subject balloon was unable to deflate which resulted in the catheter falling out of the internal carotid artery back into the aorta.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: FLOWGATE2 8F X 85CM
• Type of Device: 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: 15575915
• MDR Text Key: 302833677
• Report Number: 3012931345-2022-00183
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2024
• Device Model Number: 90485
• Device Catalogue Number: 90485
• Device Lot Number: 0000104788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1