MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 6 - 060X132 (FDA); CATHETER, PERCUTANEOUS

Catalog Number M003IC0601320

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 05/09/2016

Event Type  Injury  

Manufacturer Narrative

The subject device was disposed of at the hospital.

Event Description

It was reported that the patient underwent a mechanical thrombectomy procedure for a clot located at the right middle cerebral artery m1 segment.During the end of the procedure the patient experienced a non-symptomatic intracranial hemorrhage.No treatment was required and the outcome was reported as self-resolved.The patient was discharged home approximately three days later.The event was reported to be related to the procedure and unknown if related to the device.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.From the information provided there was no indication that the device was not used as in accordance with the labeling or that this caused or contributed to the reported event.However, hemorrhage is a known risk associated with endovascular procedures and is listed as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.

Event Description

It was reported that the patient underwent a mechanical thrombectomy procedure for a clot located at the right middle cerebral artery m1 segment.During the end of the procedure the patient experienced a non-symptomatic intracranial hemorrhage.No treatment was required and the outcome was reported as self-resolved.The patient was discharged home approximately three days later.The event was reported to be related to the procedure and unknown if related to the device.

• Brand Name: AXS CATALYST 6 - 060X132 (FDA)
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork CA NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; model farm road; fremont, CA 94538 ; 5104132500
• MDR Report Key: 5802950
• MDR Text Key: 49838747
• Report Number: 3008881809-2016-00079
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2016

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 Expiration Date: 01/31/2018
• Device Catalogue Number: M003IC0601320
• Device Lot Number: 18821256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2016
• Initial Date FDA Received: 07/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2016
• 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
• Patient Age: 87 YR