MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, PERCUTANEOUS

Catalog Number UNK_NEU

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

Patient Problems Anaphylactic Shock (1703); Stroke/CVA (1770); Hematoma (1884); Intracranial Hemorrhage (1891); Inflammation (1932); Intraocular Infection (1933); Sepsis (2067); Transient Ischemic Attack (2109); Vasodilatation (2127); Obstruction/Occlusion (2422); Pseudoaneurysm (2605); Vascular Dissection (3160); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 07/12/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : the device is not available for evaluation.

Event Description

The survey conducted in france, italy, and united states.Results from the survey stated that adverse events (intracranial hemorrhage, access site complications, stroke, transient ischemic attack (tia), vessel dissection, vessel perforation, pseudoaneurysm, acute vessel occlusion/ischemia, vasospasm, emboli, thrombosis, fever, inflammation of the puncture site, allergic reaction requiring additional medical treatment(s), infection of the puncture site requiring oral or systematic antibiotics, and hematoma) were reported.No other information was provided.

Manufacturer Narrative

Although the dhr 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, visual and functional testing as well as physical analysis 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.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 a post-market clinical follow-up (pmcf) survey was conducted for long sheath catheters (device numbers: unknown, quantity: (b)(4) and long sheath catheters plus (device unknown, quantity: (b)(4) and responses (double blinded) from physicians was received on (b)(6) 2023.Events of patient stroke, patient tia (transient ischemic attack), patient vessel dissection, patient vessel perforation, patient vessel occlusion, patient vasospasm non-serious, patient embolus, patient inflammation, patient infection and vascular access site complications non-serious were reported from clinical specialists involved in the survey were from italy, france, and united states.Based upon medical review, the reported events are observed in this complaint is anticipated in nature as per the device risk assessment.As a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to reported events of patient stroke, patient tia (transient ischemic attack), patient vessel dissection, patient vessel perforation, patient vessel occlusion, patient vasospasm non-serious, patient embolus, patient inflammation, patient infection and vascular access site complications non-serious.

Event Description

The survey conducted in france, italy, and united states.Results from the survey stated that adverse events (intracranial hemorrhage, access site complications, stroke, transient ischemic attack (tia), vessel dissection, vessel perforation, pseudoaneurysm, acute vessel occlusion/ischemia, vasospasm, emboli, thrombosis, fever, inflammation of the puncture site, allergic reaction requiring additional medical treatment(s), infection of the puncture site requiring oral or systematic antibiotics, and hematoma) were reported.No other information was provided.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 17371668
• MDR Text Key: 319502734
• Report Number: 3008881809-2023-00369
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152876
• 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: 10/04/2023

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 09/25/2023
• Supplement Dates FDA Received: 10/04/2023
• 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): Other