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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/08/2019

Event Type  Injury  

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 Description

Infant developed cardiac tamponade after about 6 hours of line being placed.

• Brand Name: SINGLE LUMEN 1.9FR SILICONE PIC CATHETER
• Type of Device: PICC, PERCUTANEOUS, PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): FOOTPRINT MEDICAL INC.; 12727 cimarron path; san antonio TX 78249 3405
• Manufacturer (Section G): FOOTPRINT MEDICAL INC.; 12727 cimarron path; san antonio TX 78249 3405
• Manufacturer Contact: robert davis ; 12727 cimarron path; san antonio, TX 78249-3405 ; 2102262600
• MDR Report Key: 9513149
• MDR Text Key: 173461000
• Report Number: 3007697249-2019-11002
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00858778006027
• UDI-Public: (01)00858778006027(17)201109(10)180828
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 DA