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

Model Number 90495

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

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

Event Date 01/21/2022

Event Type  malfunction  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that a neurovascular procedure was performed on a patient.During the procedure when attempted to inflate the subject balloon inside the patient at the target lesion, there was no visible inflation of subject balloon under fluoroscopy.The subject balloon was removed from the patient's vascular anatomy and checked.It was noted that there was a hole in the middle third of the subject balloon catheter shaft from where the fluid leaked and there was no fluid in the subject balloon and therefore the subject balloon did not inflate.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No further information is available.

Event Description

It was reported that a neurovascular procedure was performed on a patient.During the procedure when attempted to inflate the subject balloon inside the patient at the target lesion, there was no visible inflation of subject balloon under fluoroscopy.The subject balloon was removed from the patient's vascular anatomy and checked.It was noted that there was a hole in the middle third of the subject balloon catheter shaft from where the fluid leaked and there was no fluid in the subject balloon and therefore the subject balloon did not inflate.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No further information is available.

Manufacturer Narrative

D4 expiration date - added.H4 manufacturing date ¿ added.There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual 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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the issue was noticed during used of the device on the patient, and the patient's anatomy was moderately tortuous.While there are a number of potential causes for the reported issue 'balloon catheter shaft leaked during use', 'balloon has hole/perforation during use' and, 'balloon failed to inflate', because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable was assigned to this complaint.

Event Description

It was reported that a neurovascular procedure was performed on a patient.During the procedure when attempted to inflate the subject balloon inside the patient at the target lesion, there was no visible inflation of subject balloon under fluoroscopy.The subject balloon was removed from the patient's vascular anatomy and checked.It was noted that there was a hole in the middle third of the subject balloon catheter shaft from where the fluid leaked and there was no fluid in the subject balloon and therefore the subject balloon did not inflate.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No further information is available.

Manufacturer Narrative

There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was returned for analysis.Visual/microscopic inspection: the balloon catheter was found to be severely kinked/bent in multiple areas.The balloon catheter shaft was found to be damaged.There were no anomalies noted to the balloon.No holes/perforations were noted.Functional inspection: balloon has hole/perforation - n/a.Defect not confirmed during visual inspection.An attempt was made to inflate the balloon.The balloon could not be inflated due to the damaged catheter shaft and catheter shaft leakage ; however, there was no balloon leakage noted.Balloon catheter shaft leaked during use functional test - failed.The balloon catheter shaft leaked during the test, due to the damaged catheter shaft.Balloon failed to inflate functional test - failed.The balloon could not be inflated due to catheter shaft leakage.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 was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared for use as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the issue was noticed during use of the device on the patient, and the patient's anatomy was moderately tortuous.During analysis, the balloon catheter was found to be severely kinked/bent in multiple areas along its length.The balloon catheter shaft was found to be damaged (torn) on the middle third of the shaft.No anomalies were noted to the balloon during visual inspection.The balloon could not be inflated during functional testing due to leakage through the tear on the shaft.However, there was no balloon leakage noted.Therefore, the as reported 'balloon has hole/perforation during use' was not confirmed as the issue included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue or any defect which could have contributed to the event.It is probable that the catheter encountered significant force during the procedure possibly from navigating through tortuous anatomy which caused the damage found on the device.An assignable cause of procedural factors will be assigned to the as reported and as analyzed 'balloon catheter shaft leaked during use' and 'balloon failed to inflate' as well as the as analyzed 'balloon catheter kinked/bent' and 'balloon catheter broken/fractured during use' since these issues are associated with a product that met stryker design and manufacturing specifications and was used in accordance with dfu but performance was limited due to procedural and/or anatomical factors during use.

• 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: 13455503
• MDR Text Key: 285146897
• Report Number: 3012931345-2022-00021
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00815742004953
• UDI-Public: 00815742004953
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2023
• Device Model Number: 90495
• Device Catalogue Number: 90495
• Device Lot Number: 0000077731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2021
• 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: VACLOC SYRINGE 1 ML (MERIT MEDICAL SYSTEMS)