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-C
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Foreign Body In Patient (2687)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Despite numerous requests to the reporting institution, the device has not been made 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.
Event or Problem Description
It was reported that during a dressing change a leak was noted in the peripherally inserted central catheter (picc) line and the provider decided to remove the line.The picc line was clamped due to blood dripping out.Resistance was encountered when withdrawing the picc, and then the picc line broke outside the patient.An additional bedside attempt was made to remove the picc line, with resistance again encountered.It was reported that the portion of the line removed during the second attempt appeared stretched.Imaging showed that the picc line had separated and a portion remained in the patient.The patient was taken to the operating room for removal of the retained portion.
Additional Manufacturer Narrative
The investigation included evaluating the returned device which was confirmed to be stretched and separated in two places as initially reported by the customer.The stretching and break profiles are consistent with the reported resistance experienced during attempts to remove the catheter from the patient.Additionally, 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: 23360822
• Report Number: 3007697249-2025-00003
• Device Sequence Number: 13062015
• Product Code: LJS
• UDI-Device Identifier: 00858778006058
• UDI-Public: (01)00858778006058(17)261219(10)241352
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K130507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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-C
• Device Lot Number: 241352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2024
• 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 Sex: Unknown