MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 5 - 058X115 (FDA); CATHETER, PERCUTANEOUS

Catalog Number	M003IC0581150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual and microscopic examination of the returned device found that the dac shaft was broken/ fractured at the junction of the grilamid sleeve and the catheter shaft at the proximal end.There were no anomalies noted to the hoop and retaining clip.As per the additional information, there was no damage noted to the packaging.It is probable that the device was damaged as a result of handling of the device during removal of the device from its packaging.
Event or Problem Description
The review of the investigation revealed that the distal access catheter (subject device) shaft was broken.There were no clinical consequences to the patient.

• Brand Name: AXS CATALYST 5 - 058X115 (FDA)
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7699905
• Report Number: 3008881809-2018-00309
• Device Sequence Number: 1618986
• Product Code: DQY
• UDI-Device Identifier: 07613327012019
• UDI-Public: 07613327012019
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2018

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: 11/30/2018
• Device Catalogue Number: M003IC0581150
• Device Lot Number: 19449133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1