MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, PERCUTANEOUS

Catalog Number UNK_NEU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Hematoma (1884); Intracranial Hemorrhage (1891); Perforation (2001); Pseudoaneurysm (2605); Thromboembolism (2654); Vascular Dissection (3160); Embolism/Embolus (4438)

Event Date 02/07/2023

Event Type  Injury  

Event Description

It was reported during a post-market clinical follow-up (pmcf) double blind survey for the subject flowgate2® balloon guide catheter, 8f x 95cm, the following adverse events were observed; access site complications (pseudoaneurysm or hematoma), distal emboli, mortality, headaches, unknown other adverse event, spasm, problems with bgc (leak or kinking), stroke, symptomatic intracranial hemorrhage, thromboembolic event, vessel cutoff downstream, vessel dissection perforation as per the responses received.No further information is available.

Manufacturer Narrative

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

Manufacturer Narrative

Although the dhr (device history record) could not be reviewed because the lot number remains unknown, 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 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.It was reported during a post-market clinical follow-up (pmcf) survey was conducted for stryker flowgate2® balloon guide catheter device #¿s (1) (b)(6) in france, germany, italy, spain and united states that in one case a number of patient complications were noted: patient embolus, patient thromboembolic event, patient intracranial hemorrhage, patient stroke, patient vessel dissection, patient vessel perforation, patient hematoma, and patient pseudoaneurysm.The patients' outcome was unknown.The risk of the above reported list of patient harms is documented in the flowgate device directions for use (dfu), as a potential adverse event which can occur as a result of these type of procedures.Also based upon medical review, the harms observed in these complaints are anticipated in nature as per the device risk assessment.There was no indication of device malfunction or failure, therefore an assignable cause of anticipated procedural complication, will be assigned to the reported events.

Event Description

Post-market clinical follow-up (pmcf) anonymous survey was conducted for subject flowgate2® balloon guide catheter.The survey was conducted in france, germany, italy, spain and united states.During the survey, distal emboli, symptomatic intracranial hemorrhage, stroke, vessel dissection perforation, thromboembolic event, access site complications (pseudoaneurysm or hematoma) and an unknown other adverse event were reported to have occurred as per the responses received.Medical intervention was required.No other information is available about the events reported in the survey.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• 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: 16875816
• MDR Text Key: 314628898
• Report Number: 3012931345-2023-00079
• 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: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/05/2023
• Supplement Dates Manufacturer Received: 06/02/2023
• Supplement Dates FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Other