MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 5 - 058X132 (FDA); CATHETER, PERCUTANEOUS

Catalog Number	M003IC0581320
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable.
Event or Problem Description
It was reported that the subject device distal tip was came off when removing it from the brain, and the subject device distal tip moved down to the aorta.There were no reported clinical consequences to the patient.No other information provided.

• Brand Name: AXS CATALYST 5 - 058X132 (FDA)
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8201208
• Report Number: 3008881809-2018-00551
• Device Sequence Number: 1593373
• Product Code: DQY
• UDI-Device Identifier: 07613327011999
• UDI-Public: 07613327011999
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K151667
• 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
• Report Date (Section B): 12/27/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M003IC0581320
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 12/27/2018
• 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