MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS INFINITY LS .088IN ID X 90CM - US; CATHETER, PERCUTANEOUS

Model Number	GEN-10800-90
Medical Device Problem Codes	Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during carotid stenting procedure, the subject sheath was inserted into the patient¿s anatomy via radial access.The subject sheath went up easily inside the patient¿s anatomy but when it reached brachial artery, the physician was unable to advance or withdraw the subject sheath.It is not sure if the correct size of the subject sheath was chosen for the surgery because an ultrasound measurement of the vessel was not performed.The patient was taken into the operating room for additional surgery where the physician took out the stuck subject sheath along with the patient's artery.The carotid stenting procedure was not completed because of the intervention required.It was reported that the patient was having strokes which was not treated at that time.No further information is available at this point.
Event or Problem Description
It was reported that during carotid stenting procedure, the subject sheath was inserted into the patient¿s anatomy via radial access.The subject sheath went up easily inside the patient¿s anatomy but when it reached brachial artery, the physician was unable to advance or withdraw the subject sheath.It is not sure if the correct size of the subject sheath was chosen for the surgery because an ultrasound measurement of the vessel was not performed.The patient was taken into the operating room for additional surgery where the physician took out the stuck subject sheath along with the patient's artery.The carotid stenting procedure was not completed because of the intervention required.It was reported that the patient was having strokes which was not treated at that time.No further information is available at this point.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 'vascular access site complications serious' is a known and anticipated complication to these types of procedures and patient condition, and is listed as such in the device directions for use.Therefore, a cause of anticipated procedural complication was assigned to the reported event.The as reported 'catheter shaft difficulty removing/withdrawing' and 'device difficulty engaging target vessel' will be assigned procedural factors based on the event description as it appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.

• Brand Name: AXS INFINITY LS .088IN ID X 90CM - US
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11592485
• Report Number: 3008881809-2021-00149
• Device Sequence Number: 3356648
• Product Code: DQY
• UDI-Device Identifier: 07613327298260
• UDI-Public: 07613327298260
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K152876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/16/2022
• Device Model Number: GEN-10800-90
• Device Catalogue Number: GEN-10800-90
• Device Lot Number: 22022641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention