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

Model Number	P1PIC1.9-S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record for lot #180700 was reviewed.All catheters passed in-process and final inspection criteria including leak testing.The suspect device was returned for investigation.The catheter evidenced apparent signs of deformation under axial loading at the break location indicating that the catheter broke under excessive tension.Broken portion of catheter was removed surgically and the patient is doing well.
Event or Problem Description
The picc line broke during attempted extraction.The broken portion of the catheter was surgically removed.Patient is doing well.

• Brand Name: SINGLE LUMEN 1.9FR POLYURETHANE 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: 9598297
• Report Number: 3007697249-2020-00001
• Device Sequence Number: 14127519
• Product Code: LJS
• UDI-Device Identifier: 00858778006089
• UDI-Public: (01)00858778006089(17)200914(10)180700
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130507
• 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
• Type of Report: Initial
• Report Date (Section B): 01/16/2020

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: 09/14/2020
• Device Model Number: P1PIC1.9-S
• Device Lot Number: 180700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/16/2020
• 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: Required Intervention
• Patient Age: 1 DA