MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PROVENA PPICC, 4F DL, MAX TLS; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	S9274108D
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebq2477 showed no other similar product complaint(s) from this lot number.Device, not yet returned.
Event or Problem Description
It was reported by the sales rep that the facility was placing a picc, right sided placement and upon initial insertion met resistance.The placement was pulled back; manipulated the catheter and the picc went in fine on the second attempt.When the placer went to retract the sherlock stylet, she felt resistance with the stylet and removed the stylet from the picc.Upon removal, the stylet was missing the tip.The catheter was then removed and flushed to ensure the tip was not in the catheter.Chest x-ray showed approximately 3.5 cm of the sherlock tip in the patient's right axillary vein.The patient has left side swan-ganz catheter and pacemaker.The picc was trimmed to 40 cm.Interventional radiology retrieved the wire.

• Brand Name: PROVENA PPICC, 4F DL, MAX TLS
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6963639
• Report Number: 3006260740-2017-01861
• Device Sequence Number: 1221898
• Product Code: LJS
• UDI-Device Identifier: 00801741130441
• UDI-Public: (01)00801741130441
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2017

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 Catalogue Number: S9274108D
• Device Lot Number: REBQ2477
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1