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

Catalog Number	M003IC0581320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.Visual and microscopic inspection of the returned device found the catheter shaft was broken/fractured at 5mm from the strain relief at the proximal end; no other anomalies were noted.Additional information confirmed there was no damage noted to the packaging.Based on the information provided and investigation results, it is probable that the catheter shaft broke as a result of handing the device during removal from its packaging; human factors issue has been assigned to this event.
Event or Problem Description
Analysis of the returned device found the catheter shaft was broken.There was no clinical consequence to the patient as a result of this event.

• 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: 7488661
• Report Number: 3008881809-2018-00204
• Device Sequence Number: 19323692
• Product Code: DQY
• UDI-Device Identifier: 07613327011999
• UDI-Public: (01)07613327011999(17)190131(10)19560019
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: M003IC0581320
• Device Lot Number: 19560019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1