MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC PROVENA SOLO 5FR DUAL LUMEN FT MAX BARRIER PLUS WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redu3806 showed no other similar product complaint(s) from this lot number.[mw5091977.Pdf].
Event or Problem Description
It was reported per received medwatch "picc insertion with sherlock 3cg placement verified line in superior vena cava.Had some difficulty getting picc line to drop in superior vena cava prior.It appeared to be going up into internal jugular and circling per monitor.Once in place i attempted to pull wire out and heard a pop examined wire it appeared broken.Pulled picc line out hoping wire may still be in catheter and checked for the entire 40cm line was intact.Ordered for stat chest x-ray and stat cta (computed tomography angiography) to be safe.Started piv for cta and it confirmed 3.7cm wire left inpatient right subclavian vein.Informed house supervisor, primary md, ir director and ir md.Saved picc line and wire for review and ir retrieved a 3.7cm wire from patient".

• Brand Name: POWERPICC PROVENA SOLO 5FR DUAL LUMEN FT MAX BARRIER PLUS WITH BIOPATCH
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9848487
• Report Number: 3006260740-2020-00876
• Device Sequence Number: 19691175
• Product Code: LJS
• UDI-Device Identifier: 00801741155215
• UDI-Public: (01)00801741155215
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2020
• Report Date (Section F): 12/28/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: S1295108FD5
• Device Lot Number: REDU3806
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/26/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/18/2020
• 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: Other; Required Intervention
• Date Report Sent to FDA: 12/28/2019