MAUDE Adverse Event Report: FOOTPRINT MEDICAL, INC. 1.9 FR SILICONE PICC PROCEDURAL KIT; PICC, PERCUTANEOUS, PERIPHERALLY INSERTED CENTRAL CATHETER

Model Number	S1PIC1.9-S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	02/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product and circumstances have been investigated and it is clear by the events that placement of the catheter tip into the heart was related to this incident.Pericardial effusion is a known outcome when picc lines are inadvertently placed into the heart, as has been determined by x-ray to be the case in this incident.The returned catheter has been investigated and has been determined to be fully functional and without anomaly.The catheter tip and catheter body have been inspected under magnification and show no increased risk of causing an effusion.It is reasonable to conclude that the effusion was not a result of the product and more likely a result of placement into the heart.
Event or Problem Description
Picc line was placed in left brachial vein.Serial x-rays showed tip of catheter in the right atrium.An echo showed large pericardial effusion.

• Brand Name: 1.9 FR SILICONE PICC PROCEDURAL KIT
• Common Device Name: PICC, PERCUTANEOUS, PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): FOOTPRINT MEDICAL, INC.; 12727 cimarron path; san antonio TX 78249 3405
• MDR Report Key: 7397715
• Report Number: 3007697249-2018-02002
• Device Sequence Number: 19013604
• Product Code: LJS
• UDI-Device Identifier: 00858778006041
• UDI-Public: (01)00858778006041(17)190811(10)170587
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K093252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2018

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: 08/11/2018
• Device Model Number: S1PIC1.9-S
• Device Lot Number: 170587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 04/04/2018
• 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: 1 DA