MAUDE Adverse Event Report: ACCESS SCIENTIFIC, LLC POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER; INTRODUCER CATHETER

Model Number	3FR ED
Health Effect - Clinical Codes	Pain (1994); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The floor nurse attempted to remove the catheter from the patient's arm.During the catheter removal process, the nurse reported that it was difficult and that the patient appeared to be in pain.Upon removal of the catheter from the patient's arm, the nurse observed an unknown angle to the catheter tip.The incident was discussed among the hospital board and they suspect the incident was due to user error.Furthermore, an xray was taken on the patient's arm and it appeared that remnants of the catheter remained in the patient's arm.The hospital continued to monitor the patient's current condition and intervention was not confirmed.

• Brand Name: POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): ACCESS SCIENTIFIC, LLC; 3910 sorrento valley boulevard; suite 200; san diego CA 92121
• MDR Report Key: 7970410
• Report Number: 3009549229-2018-00002
• Device Sequence Number: 1681680
• Product Code: DYB
• UDI-Device Identifier: 10859821006527
• UDI-Public: 10859821006527
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/16/2018

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 Model Number: 3FR ED
• Device Catalogue Number: 92109
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization