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

Model Number 90495

Device Problem Deflation Problem (1149)

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

Event Date 06/21/2023

Event Type  malfunction  

Event Description

Hold for jf 7.14.It was reported that during an endovascular procedure the subject balloon was not deflating before removing it from internal carotid artery ica.Hence doctor had to pull out with out balloon deflation.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

Manufacturer Narrative

H4: manufacturing date ¿ added.D4: expiration date - added.There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual testing as well as functional testing cannot be performed.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 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.Additional information received indicated that the device was prepared for use as per the directions for use.There was no damage noted to the packaging prior to opening the packaging and 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.The balloon was successfully deflated during preparation but it was reported that 'the balloon was not deflating before removing it from ica.Hence doctor has to pull out with out balloon deflation.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.

Event Description

It was reported that during an endovascular procedure the subject balloon was not deflating before removing it from internal carotid artery ica.Hence doctor had to pull out with out balloon deflation.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: FLOWGATE2 8F X 95CM
• 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: 17322638
• MDR Text Key: 319093831
• Report Number: 3012931345-2023-00160
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00815742004953
• UDI-Public: 00815742004953
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 09/13/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2024
• Device Model Number: 90495
• Device Catalogue Number: 90495
• Device Lot Number: 0000125396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 09/07/2023
• Supplement Dates FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• 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
• Treatment: CATALYST 6 CATHETER (STRYKER).
• Patient Age: 55 YR
• Patient Sex: Male