MAUDE Adverse Event Report: ARSTASIS INC. AXERA 2 ACCESS SYTEM; INTRODUCER CATHETER

Catalog Number AXE200

Device Problems Material Separation (1562); Device Operates Differently Than Expected (2913)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Type  Injury  

Event Description

Multiple attempts were made to gain access to the artery, which was in a calcified section of the sfa.As a result of (b)(6) bleeding around the axera upon insertion, the physician proceeded to convert the case to stand arteriotomy.He slid the heel actuator forward, but had difficulty disengaging the heel and decided to sever the heel deployment wire.He was then able to remove the device from the patient and manually separate the device body from the latchwire.A 6f sheath was inserted over the latchwire.However, blood continued to leak around the sheath and a hematoma was noted.The physician upsized to a 7f sheath and hemostasis was achieved, however, blood flow in the sfa was then impaired.The sheath was removed the manual compression held.Access was gained in the left common femoral and an up and over approach was made to visualize the previous arteriotomy.As the calcification was impeding manual compression and hemostasis, a balloon was used to facilitate haemostasis, but was unsuccessful.A covered stent was then successfully used to seal the arteriotomy.

Manufacturer Narrative

An attempt to obtain additional complaint information from the user facility, such as a patient information and event date, was made without success.The device was not returned; therefore, product failure analysis was not possible.The lot number was not reported and could not be distinguished from multiple lots shipped to the facility.Therefore, a review of the device history record for this lot was not performed.The axera 2 access system instructions for use (ifu), was reviewed.Hematoma and other possible adverse effects of vascular access procedures are listed in the adverse effects section of the product ifu.The ifu provides the appropriate instructions on device usage, warnings and precautions; therefore, no update is required.Based on the review completed, it is unknown whether or not the device was out of specification as it cannot be definitively determined.The root cause, based on available information, is unknown as it cannot be definitively determined.

• Brand Name: AXERA 2 ACCESS SYTEM
• Type of Device: INTRODUCER CATHETER
• Manufacturer (Section D): ARSTASIS INC.; redwood city CA
• Manufacturer Contact: susan hale, director of quality ; 6500 kaiser drive suite 120; fremont, CA 94555 ; 6502618039
• MDR Report Key: 4112891
• MDR Text Key: 4839107
• Report Number: 3008493244-2014-00027
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AXE200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON; 6F/7F SHEATH; STENT
• Patient Outcome(s): Required Intervention