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 Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Despite several attempts to obtain additional information from the user facility, no additional information was available regarding event circumstances or patient outcome.In-house investigation included review of device history records.The investigation indicated no evidence of manufacturing related issues that would have contributed to the event.
Event or Problem Description
It was reported that during attempted removal from left scalp, the picc (peripherally inserted central catheter) line retained approximately 10 cm.

• 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: 18886655
• Report Number: 3007697249-2024-00001
• Device Sequence Number: 7591196
• Product Code: LJS
• UDI-Device Identifier: 00858778006058
• UDI-Public: (01)00858778006058(17)250602(10)230614
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2024

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: 06/02/2025
• Device Model Number: P1PIC1.4-C
• Device Lot Number: 230614
• 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: 02/12/2024
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 05/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2023
• 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: 8 MO
• Patient Sex: Male
• Patient Race: White