MAUDE Adverse Event Report: ACCESS SCIENTIFIC, LLC POWERWAND; INTRODUCER, CATHETER

Lot Number 1720440

Device Problem Entrapment of Device (1212)

Patient Problem No Code Available (3191)

Event Date 03/26/2018

Event Type  malfunction  

Event Description

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.

• Brand Name: POWERWAND
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ACCESS SCIENTIFIC, LLC; 3910 sorrento valley blvd #200; san diego CA 92121
• MDR Report Key: 7581504
• MDR Text Key: 110453654
• Report Number: 7581504
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2018,05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 1720440
• Other Device ID Number: M1554
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; NO, THIS WAS A FAIRLY NEW PRODUCT WE WERE TRIALIN
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Weight: 125