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 Stroke/CVA (1770)

Event Date 03/06/2016

Event Type  Injury  

Event Description

It was reported that the catheter (subject device) could not be navigated into the middle cerebral artery.The distal tip of the subject device was reported to be corrupt.Another manufacturer's catheter was used but it was unable to be advanced to the target lesion as well.The clot was unable to be removed from the patient and the patient had a stroke.No other information is available.

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Analysis of the device revealed that the distal end was kinked and the distal tip was damaged/deformed.During functional evaluation, resistance was experienced during advancement of a 0.059¿ mandrel through the catheter shaft.The mandrel was unable to be advanced out of the catheter shaft distal end.The device dimension were found to be within specification.Information available indicated that the device was confirmed to be in good condition prior to use, the patient anatomy was moderately tortuous and a competitor device was also not able to be advanced into the same location leading to the patient being unable to be treated.Based on the information available, it is likely that the subject device sustained damage during the clinical procedure resulting in the inability to reach the target site.An assignable cause of operational context was assigned to this investigation.

Event Description

It was reported that the catheter (subject device) could not be navigated into the middle cerebral artery.The distal tip of the subject device was reported to be corrupt.Another manufacturer's catheter was used but it was unable to be advanced to the target lesion as well.The clot was unable to be removed from the patient and the patient had a stroke.No other information is available.

• 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 NA
• Manufacturer Contact: sanda dracic ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 5549162
• MDR Text Key: 41936451
• Report Number: 3008853977-2016-00121
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2016

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: 12/31/2017
• Device Catalogue Number: M003IC0601320
• Device Lot Number: 18772651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2016
• Initial Date FDA Received: 04/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2015
• 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