MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS INFINITY LS PLUS LONG SHEATH (90CM); CATHETER, PERCUTANEOUS

Catalog Number	INC-11196-90
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guide catheter had fractured inside the patient during the procedure.The physician replaced it with a new guide catheter and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The dilator used with the axs infinity catheter was not returned.Visual inspection of the device revealed that there was a kink at its distal end and some procedural fluid was found on the catheter up to the hub.No other anomalies were observed.Functional testing could not be performed due to the damage to the returned device.The device was stated to be in good condition and was prepared according to the dfu specifications.The risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Additional information indicated that continuous flush was maintained, however, the anatomy was very tortuous which could be a contributing factor to the kink on the guide catheter.The reported event of device fracture was not confirmed based on the observed device analysis, therefore an assignable cause of not confirmed has been assigned to the investigation.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that the guide catheter had fractured inside the patient during the procedure.The physician replaced it with a new guide catheter and continued the procedure without clinical consequences to the patient.

• Brand Name: AXS INFINITY LS PLUS LONG SHEATH (90CM)
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8408897
• Report Number: 3008881809-2019-00066
• Device Sequence Number: 13960638
• Product Code: DQY
• UDI-Device Identifier: 07613327459203
• UDI-Public: 07613327459203
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K152876
• 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,Followup
• Report Date (Section B): 05/03/2019

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: 08/01/2021
• Device Catalogue Number: INC-11196-90
• Device Lot Number: 13197-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1