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); Headache (1880); Hematoma (1884); Intracranial Hemorrhage (1891); Perforation (2001); Vasoconstriction (2126); Obstruction/Occlusion (2422); Pseudoaneurysm (2605); Thromboembolism (2654); Vascular Dissection (3160)

Event Date 02/07/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Post-market clinical follow-up (pmcf) anonymous survey was conducted for the subject balloon guide catheter.The survey was conducted in france, germany, italy, spain and united states.During the survey, symptomatic intracranial hemorrhage, stroke, vessel cutoff downstream, vessel dissection perforation, thromboembolic event, access site complications (pseudoaneurysm or hematoma), spasm requiring medication and headaches were reported to have occurred as per the responses received.No other information is available about the events reported in the survey.

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 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.It was reported during a post-market clinical follow-up (pmcf) survey conducted for stryker merci® balloon guide catheter (bgc) device #¿s (5) 90073 and (12) 90074 in france, germany, italy, spain and united states that in one case a number of patient complications were noted: ¿patient intracranial hemorrhage', 'patient stroke', 'patient vessel occlusion',' patient vessel dissection', 'patient thromboembolic event', 'patient vasospasm serious', 'patient headache serious', 'patient hematoma', 'patient pseudoaneurysm', and 'patient vessel perforation'.The patients' outcome was unknown.The risk of the above reported list of patient harms is documented in the merci device directions for use (dfu), as a potential adverse event which can occur as a result of these type of procedures.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 the subject balloon guide catheter.The survey was conducted in france, germany, italy, spain and united states.During the survey, symptomatic intracranial hemorrhage, stroke, vessel occlusion, vessel dissection perforation, thromboembolic event, access site complications (pseudoaneurysm or hematoma), spasm requiring medication and headaches were reported to have occurred as per the responses received and 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: 16876257
• MDR Text Key: 314634589
• Report Number: 3012931345-2023-00082
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112404
• 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: 06/23/2023

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: 06/01/2023
• Supplement Dates FDA Received: 06/23/2023
• 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