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	01/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the catheter shaft was noted to be stretched and separated just distal to the hub under the strain relief.The inner coil was noted to be stretched.The strain relief was removed, and it appeared to be separated due to excessive manipulation.Blood was noted in the catheter up to its proximal hub.Functional testing could not be performed due to the anomalies noted to the device.In case of this complaint, the additional information provided by the customer indicated that the device was confirmed to be in good condition prior to use and was prepared as per the direction for use (dfu), continuous flush was maintained, and resistance was encountered during the procedure around the arch.Based on analysis and the information provided, it is possible that excessive force was used to overcome resistance encountered in the patient¿s anatomy during the procedure causing the inner coil of the catheter to stretch and the shaft to separate.As a result, a probable cause of handling damage has been assigned to the as analyzed event guide catheter shaft broken/fractured inside patient since the defects appear to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the direction for use (dfu), but performance was limited due to procedural or anatomical factors during use.
Event or Problem Description
Analysis of the retuned device found that the guide catheter shat broken.There were no clinical consequences to the patient as a result of this event.

• 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: 8553249
• Report Number: 3008853977-2019-00036
• Device Sequence Number: 2358514
• Product Code: DQY
• UDI-Device Identifier: 07613327459203
• UDI-Public: 07613327459203
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 04/25/2019

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: 08/23/2021
• Device Catalogue Number: INC-11196-90
• Device Lot Number: 13271-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1