MAUDE Adverse Event Report: FOOTPRINT MEDICAL INC. POLYURETHANE, SINGLE LUMEN 1.4FR (Ø 0.47 MM) X 30 CM LENGTH; PICC

Model Number	P1PIC1.4-S
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during removal of the peripherally inserted central catheter (picc), resistance was encountered and the picc line fractured leaving 11.5 cm in the patient's leg.The patient was taken to another facility for surgery to remove the retained segment.
Additional Manufacturer Narrative
Device was not available for examination.In-house investigation included review of device history records.The investigation indicated no evidence of manufacturing or material related issues that would have contributed to the event.

• Brand Name: POLYURETHANE, SINGLE LUMEN 1.4FR (Ø 0.47 MM) X 30 CM LENGTH
• Common Device Name: PICC
• Manufacturer (Section D): FOOTPRINT MEDICAL INC.; 5823 sebastian place; san antonio TX 78249
• Manufacturer (Section G): FOOTPRINT MEDICAL INC.; 5823 sebastian place; san antonio TX 78249
• Manufacturer Contact: robert davis ; 5823 sebastian place; san antonio, TX 78249 ; 2102262600
• MDR Report Key: 25361434
• Report Number: 3007697249-2026-00005
• Device Sequence Number: 16115578
• Product Code: LJS
• UDI-Device Identifier: 00858778006072
• UDI-Public: (01)00858778006072(17)270918(10)250708
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K130507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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
• Device Model Number: P1PIC1.4-S
• Device Lot Number: 250708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 9 DA
• Patient Sex: Male
• Patient Race: White