MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF 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	04/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while tracking, the subject device catheter was fractured in the middle of the catheter.There were no clinical consequences to the patient due to the reported event.
Event or Problem Description
It was reported that while tracking, the subject device catheter was fractured in the middle of the catheter.There were no clinical consequences to the patient due to the reported event.
Additional Manufacturer Narrative
The edhr (electronic device history record) for the device lot is created and maintained in mes (manufacturing execution system).Automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During analysis, the long sheath was found to be separated at distal to the strain relief.The shaft was kinked and stretched at the fracture sites.The functional test could not be performed due to the condition of the returned device.Based on visual inspection, it appears the outer shaft kinked first and then stretched and separated following additional manipulation of the device while navigating in the patient.Since no resistance was reported during the procedure, it does not appear that excessive handling was involved.A probable cause of procedural factors has been assigned to the reported event and analyzed anomalies, since this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the directions for use (dfu), but performance was limited due to procedural factors during use.

• Brand Name: AXS INFINITY LS PLUS LONG SHEATH (90CM)
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 8557421
• Report Number: 3008853977-2019-00037
• Device Sequence Number: 1744330
• Product Code: DQY
• UDI-Device Identifier: 07613327459203
• UDI-Public: 07613327459203
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: 152876
• 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): 06/03/2019

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: 01/18/2022
• Device Catalogue Number: INC-11196-90
• Device Lot Number: 13717-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1