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

Catalog Number M003IC060132A0

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device is not available.

Event Description

It was reported that the physician advanced the distal access catheter (subject device) into the internal carotid artery (ica), resistance was encountered.The distal access catheter was retrieved from the patient.Under an angiography showed that the distal marker was inside the long sheath (non stryker).The distal marker was retrieved and the procedure was completed with a different device.There were no clinical consequences to the patient reported.

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.Based on the review of the information indicated that the patient¿s anatomy was very tortuous and the friction was encountered during advancement of the device which subsequently might have caused to the marker band to be damaged.An assignable cause of operational context has been assigned to this reported event, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the direction for use (dfu) but due to procedural and/or anatomical factors during use, the device performance was limited.

Event Description

It was reported that the physician advanced the distal access catheter (subject device) into the internal carotid artery (ica), resistance was encountered.The distal access catheter was retrieved from the patient.Under an angiography showed that the distal marker was inside the long sheath (non stryker).The distal marker was retrieved and the procedure was completed with a different device.There were no clinical consequences to the patient reported.

• Brand Name: AXS CATALYST 6 - 060X132 (CE)
• Type of Device: CATHETER, PERCUTEANEOUS
• 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 NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6941771
• MDR Text Key: 89831441
• Report Number: 3008881809-2017-00437
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K151667
• 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: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: M003IC060132A0
• Device Lot Number: 19626798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2017
• 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 Age: 85 YR