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

Model Number	90485
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that after pta was performed, the subject balloon was able to inflate and deflate without any problem during preparation.While the physician attempted to retrieve the subject balloon from the patient's anatomy, the subject balloon would not deflate.However, the physician retrieved the subject balloon to the inguinal region and then removed it along with the sheath.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.The device history record (dhr) confirms that the device met all material, assembly and performance specifications.No visual or functional inspection was performed due to the product was not returned.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, the subject device was able to inflate and deflate without any problems during preparation.The device was tried to retrieve; however, the balloon did not deflate.As per the additional information, the balloon was inflated successfully during preparation, 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 normal.While there are a number of potential causes for the reported issue, because the device was not returned and a review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to this complaint.
Event or Problem Description
It was reported that after pta was performed, the subject balloon was able to inflate and deflate without any problem during preparation.While the physician attempted to retrieve the subject balloon from the patient's anatomy, the subject balloon would not deflate.However, the physician retrieved the subject balloon to the inguinal region and then removed it along with the sheath.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• 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: kathirvel s ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 12685830
• Report Number: 3012931345-2021-00173
• Device Sequence Number: 13794047
• Product Code: DQY
• UDI-Device Identifier: 00815742004854
• UDI-Public: 00815742004854
• 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): 02/16/2022

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: 01/11/2023
• Device Model Number: 90485
• Device Catalogue Number: 90485
• Device Lot Number: 0000057012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• 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