MAUDE Adverse Event Report: FOOTPRINT MEDICAL INC. 1.9FR SINGLE LUMEN SILICONE PIC CATHETER; PICC

Model Number	S1PIC1.9-C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Stroke/CVA (1770)
Date of Event	07/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer requested a review of the catheter to determine if the catheter could have contributed to the event.Internal investigation of the returned catheter included inspection and testing of the catheter tubing, molded hub, and luer taper.No potential for air egress/ingress was identified.Internal investigation also included reviewing 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 a patient had experienced a stroke due to an air embolism.A silicone peripherally inserted central catheter (picc) was in place at the time of the event.

• Brand Name: 1.9FR SINGLE LUMEN SILICONE PIC CATHETER
• 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: 19973701
• Report Number: 3007697249-2024-00005
• Device Sequence Number: 8461217
• Product Code: LJS
• UDI-Device Identifier: 00858778006027
• UDI-Public: (01)00858778006027(17)250804(10)230884
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K093252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2024

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: 08/04/2025
• Device Model Number: S1PIC1.9-C
• Device Lot Number: 230884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• 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: Life Threatening
• Patient Sex: Unknown