MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 2.6F X50CM DUAL VASCU-PICC

Model Number	MR17012600
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Death
Event or Problem Description
Picc inserted at right cephalic vein.It was trimmed.Initially there was 1cm external length immediately after insertion.Tip location confirmed by x-ray.Secured to patient with secure port iv tissue adhesive and tegaderm.On (b)(6) 2024 the picc had migrated to heart.External length noted to be same as date of insertion (1cm).Tip position verified by x-ray.Picc pulled back/repositioned to patient's svc junction, so it was in a safe position.Additional 1.5 cm pulled out, for a total of 2.5cm external length after intervention.On (b)(6) 2024 the patient's parents withdrew care and patient died.Cause of death: severe hypoxic ischemic encephalopathy (hie).
Additional Manufacturer Narrative
Our investigation is ongoing.A follow up report will be submitted when the investigation is complete.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
The device was not returned for evaluation.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.Without an evaluation of the device a root cause cannot be determined but is not likely related to manufacturing.Spontaneous catheter migration is a known, documented complication of piccs.The report indicated that the patient's death was not directly related to the catheter tip migration.Cause of death was listed as severe hypoxic ischemic encephalopathy (hie).The instructions for use (ifu) lists malposition/migration as a common complication.Included in the ifu are the following warnings: confirm catheter tip position by x-ray prior to use.Monitor tip placement routinely per institution policy.During all dressing changes, the external length of the catheter should be assessed to determine if catheter migration has occurred.Periodically confirm catheter placement and tip location.

• Brand Name: 2.6F X50CM DUAL VASCU-PICC
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 18675335
• Report Number: 2518902-2024-00014
• Device Sequence Number: 6223404
• Product Code: LJS
• UDI-Device Identifier: 00884908093711
• UDI-Public: 00884908093711
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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: Other
• Device Expiration Date: 10/12/2025
• Device Model Number: MR17012600
• Device Catalogue Number: MR17012600
• Device Lot Number: MQLT600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• 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: Death
• Patient Sex: Unknown