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

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	12/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
It was reported that prior to the procedure, the catheter hub was broken when removed from the packaging.There were no clinical consequences reported due to this event.No additional information was provided.
Event or Problem Description
It was reported that prior to the procedure, the catheter hub was broken when removed from the packaging.There were no clinical consequences reported due to this event.No additional information was provided.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.It was reported that during visual inspection, the catheter was found to be separated on its proximal end.A small amount of blood was found on the catheter hub.The catheter strain relief was removed and was examined.The catheter was separated under the stain relief just distal to the hub.The inner coil was stretched but still intact.Functional testing could not be performed due to the anomalies note to the catheter.In case of this complaint, the reported complaint was confirmed.Analysis and review of available information appears to be associated with a product that met stryker design and manufacture specifications and was used in accordance with the direction for use (dfu), but performance was limited due to the procedural and/or anatomical factors during use.As a result, a probable cause of procedural factors was assigned to the as reported and analyzed issue 'nv - guide catheter shaft broken/fractured inside patient'.

• Brand Name: AXS INFINITY LS PLUS LONG SHEATH (90CM)
• Common Device Name: CATHETER, PERCUTEANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 8240722
• Report Number: 3008853977-2019-00010
• Device Sequence Number: 2279997
• Product Code: DQY
• UDI-Device Identifier: 07613327459203
• UDI-Public: 07613327459203
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 03/12/2019

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: 08/14/2021
• Device Catalogue Number: INC-11196-90
• Device Lot Number: 13250-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1