FDA Adverse Event Malfunction Summary report: N

POWERWAND

MDR report key: 7581504 · Received June 8, 2018

Report

Report Number
7581504
Event Type
Malfunction
Date Received
June 8, 2018
Date of Event
March 26, 2018
Report Date
May 17, 2018
Manufacturer
ACCESS SCIENTIFIC, LLC
Product Code
DYB
Product Problem
Yes
Report Source
User Facility report
Reporter Location
UT, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

RN WAS CALLED BY THE PATIENT CARE TECHNICIAN (PCT) INTO THE PATIENT'S ROOM. WHEN SHE WALKED INTO THE ROOM, THE PATIENT WAS SITTING ON THE BED AND THE PCT ASKED HER TO LOOK AT THE IV SINCE "IT LOOKED LIKE IT WAS BROKEN." THE PATIENT STATED SHE WAS WASHING HER HAIR IN THE SHOWER AND HER IV GOT CAUGHT AND SHE PULLED AND "IT DIDN'T FEEL RIGHT", SO SHE NOTIFIED THE PCT, THEN THE PCT ASSISTED HER OUT OF THE SHOWER. RN NOTIFIED HER CHARGE NURSE. SHE CALLED THE PICC TEAM. THE PICC TEAM MEMBER INSTRUCTED THEM TO PLACE A TOURNIQUET ON THE PATIENT'S AFFECTED ARM. RN PLACED A TOURNIQUET ON THE PATIENT RIGHT UPPER ARM. THE MD WAS NOTIFIED AND SHE TOLD THEM TO FOLLOW THE PICC TEAM'S RECOMMENDATIONS SINCE SHE WAS NOT SURE WHAT SHOULD BE DONE. A PICC TEAM MEMBER CAME TO THE PATIENT'S ROOM AND FOUND THE IV CATHETER IN THE PATIENT'S FOREARM WITH AN ULTRASOUND. THE PICC TEAM MEMBER CALLED HER BOSS AND WAS REFERRED TO THE VASCULAR SURGEON. THE VASCULAR SURGEON TOLD THE PICC TEAM MEMBER TO ATTEMPT TO TAKE IT OUT. THE PICC TEAM MEMBER CALLED ANOTHER PICC TEAM MEMBER TO ASSIST HER IN THE ATTEMPT TO REMOVE THE CATHETER. THEY WERE NOT SUCCESSFUL AND CONTACTED THE VASCULAR SURGEON AGAIN AND THE VASCULAR SURGEON'S RESIDENT WAS SENT TO REMOVE THE CATHETER. ONCE THE RESIDENT ARRIVED, SHE ATTEMPTED TO REMOVE THE CATHETER WITH THE AID OF ULTRASOUND. SHE WAS SUCCESSFUL IN REMOVING THE CATHETER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
423744 POWERWAND INTRODUCER, CATHETER DYB ACCESS SCIENTIFIC, LLC 1720440

Patients

Seq Age Sex Outcome Treatment
1 32 YR Other NO OTHER THERAPIES| NO, THIS WAS A FAIRLY NEW PRODUCT WE WERE TRIALIN