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

Model Number	S1PIC1.9-C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	11/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device was returned for investigation.Catheter was received without any apparent signs of damage.Inspection of the returned catheter revealed that there was no device failure and that the device functioned as intended.The device history record for lot #180828 was reviewed.All catheters passed in-process and final inspection criteria including leak testing.Cardiac tamponade is a known inherit risk during the use of peripherally inserted central catheters and most commonly attributed to a malpositioned catheter tip.
Event or Problem Description
Infant developed cardiac tamponade after about 6 hours of line being placed.

• Brand Name: SINGLE LUMEN 1.9FR SILICONE PIC CATHETER
• 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: 9513149
• Report Number: 3007697249-2019-11002
• Device Sequence Number: 16258248
• Product Code: LJS
• UDI-Device Identifier: 00858778006027
• UDI-Public: (01)00858778006027(17)201109(10)180828
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K091488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 12/23/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/09/2020
• Device Model Number: S1PIC1.9-C
• Device Lot Number: 180828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/23/2019
• 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