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

Model Number	90485
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that the subject balloon catheter was prepared and deflated according to instructions.When attempting to place the subject balloon catheter during the procedure, it failed to inflate, no inflation was seen on x-ray.The subject balloon failed to keep the nacl/contrast mixture and the subject balloon was observed to be leaking.The procedure was completed without clinical consequences to the patient due to this event.No other information was provided.
Event or Problem Description
It was reported that the subject balloon catheter was prepared and deflated according to instructions.When attempting to place the subject balloon catheter during the procedure, it failed to inflate, no inflation was seen on x-ray.The subject balloon failed to keep the nacl/contrast mixture and the subject balloon was observed to be leaking.The procedure was completed without clinical consequences to the patient due to this event.No other information was provided.
Additional Manufacturer Narrative
There are controls in the manufacturing process at salt lake city to ensure that all product is manufactures to specification, prior to its release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported complaint could not be confirmed and it could not be definitively determined if the device failed to meet specifications because 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, when attempting to place the subject balloon during the procedure, it failed to inflate, no inflation was seen on x-ray.The subject balloon failed to keep the nacl/contrast mixture and the subject balloon was leaking.Additional information states that, the subject device was prepared as per the dfu, the subject 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 moderately tortuous.As the device was not returned for analysis and a review of all available information fails to indicate a root cause or potential root cause of the reported event, an assignable cause of undeterminable will be assigned to the reported 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: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 12667757
• Report Number: 3012931345-2021-00171
• Device Sequence Number: 4212395
• Product Code: DQY
• UDI-Device Identifier: 00815742004854
• UDI-Public: 00815742004854
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

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: 08/18/2022
• Device Model Number: 90485
• Device Catalogue Number: 90485
• Device Lot Number: 0000050226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• 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