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

Model Number	10117
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient at the (b)(6) medical center located at (b)(6) experienced an adverse event that involved access scientific, llc's product, the powerwand xl introducer with an extended dwell catheter, model 3fr 6 cm, catalog number 94122.The details of the event is described as follows, the hospital picc team was notified that the device (catheter) broke and remnants of the device (catheter) remained in the patient's arm.The patient reported that the breakage occured while the patient was taking a shower.The patient reported having a gel substance in her hair from a previous procedure that of which she was trying to remove in the shower.While in the shower, the device (catheter) was wrapped in aqua guard.While the patient was removing the gel substance from her hair, the device (catheter) was caught in her hair and the device (catheter) broke apart.Immediately after the incident had occured, the hospital's picc nurse evaluated the arm via ultrasound method and determined that 6 cm of the device (catheter) remained superficial in the expected location within the forearm.After collaboration from physicians, the device (catheter) remnants were removed from the patient's arm using local anesthetic and the 'cut-down' procedure.The surgical procedure was performed by the surgical resident.

• Brand Name: POWERWAND XL INTRODUCER WITH AN EXTENDED DWELL CATHETER
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): ACCESS SCIENTIFIC, LLC; 3910 sorrento valley boulevard; suite 200; san diego CA 92121
• MDR Report Key: 7526476
• Report Number: 3009549229-2018-00001
• Device Sequence Number: 1590478
• Product Code: DYB
• UDI-Device Identifier: 20859821006104
• UDI-Public: 20859821006104
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K162322
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 10117
• Device Catalogue Number: 94122
• Device Lot Number: I720440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 05/18/2018
• 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: Required Intervention
• Patient Age: 45 YR