MAUDE Adverse Event Report: FOOTPRINT MEDICAL, INC.; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	P1PIC1.4-S
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Since [date redacted] - less than one month, have been 3 indwelling picc [peripherally inserted central catheter] requiring removal due to occlusion.They have all been the same brand and lot#, 1.4fr picc(s) from the footprint brand, lot# 250098.Patient 1: picc placed [date redacted].Removed: three days later [date redacted] - unable to flush/occluded patient was receiving both tpn and ampicillin.Tpn paused and line clamped while ampicillin was given.Patient 2: picc placed [date redacted].Removed the following day [date redacted] - unable to flush/occluded patient was receiving both tpn and ampicillin.Tpn paused and line clamped while ampicillin was given.Additional picc placed [date redacted], removed (pulled out) on [date redacted] - approximately 30 days later.At this time the clot was noted.Patient was treated for left cephalic superficial venous thrombus.Additional picc placed [date redacted], lovenox (enoxaparin) given to treat thrombosis.Picc was removed on [date redacted] - 10 days later, with no issues with the line.Patient 3: picc placed [date redacted].Removed [date redacted] - approximately 7 days later - unable to flush/occluded patient was receiving both tpn and ampicillin.Tpn paused and line clamped while ampicillin was given.Occlusion of picc line was not immediately following ampicillin infusion, but occurred within 24 hours.

• Brand Name: NA
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): FOOTPRINT MEDICAL, INC.; 5823 sebastian place; san antonio TX 78249
• MDR Report Key: 22859975
• Report Number: 22859975
• Device Sequence Number: 13089655
• Product Code: LJS
• UDI-Device Identifier: 00858778006072
• UDI-Public: (01)00858778006072(17)270213(10)250098
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2025
• Report Date (Section F): 08/18/2025

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-S
• Device Catalogue Number: P1PIC1.4-S
• Device Lot Number: 250098
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 DA
• Patient Sex: Male
• Date Report Sent to FDA: 08/18/2025