MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS INFINITY LS PLUS LONG SHEATH (80CM); CATHETER, PERCUTANEOUS

Catalog Number	INC-11196-80
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was repoted that upon removal of the device, the sheath started to stretch and the shaft was broken.The device was safely removed from the patient and there were no clinical consequences to the patient due to the reported event.
Event or Problem Description
It was reported that upon removal of the device, the sheath started to stretch and the shaft was broken.The device was safely removed from the patient and there were no clinical consequences to the patient due to the reported event.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Analysis of the returned device found that the device was severely kinked, stretched, and separated in several places along its length.Additionally, the distal tip marker and distal lumen were compressed.Functional evaluation could not be performed due to the anomalies found on the device.Additional information provided by the customer indicated that the device was confirmed to be in good condition after unpacking and preparation, the device was prepared as per the device direction for use (dfu) instructions, and there was resistance during use when pulling the device out from the patient.The device was removed safely from the patient without any adverse consequences.Based on the device analysis and information provided, it appears the catheter was kinked/compressed then stretched and broke due to excessive pulling forces applied against resistance during removal from the patient.Therefore, an assignable cause of handling damage has been assigned to the reported event and analyzed anomalies.

• Brand Name: AXS INFINITY LS PLUS LONG SHEATH (80CM)
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 8092936
• Report Number: 3008853977-2018-00065
• Device Sequence Number: 1326795
• Product Code: DQY
• UDI-Device Identifier: 07613327459197
• UDI-Public: 07613327459197
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/15/2019

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: 07/25/2021
• Device Catalogue Number: INC-11196-80
• Device Lot Number: 13168-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1