PowerPICC Provena S9385108Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741112874), received between May 30, 2018 and Feb 14, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2019Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT PICC "FRACTURED" AT THE 2CM MARK AFTER A 24 HOUR DWELL TIME. THE EXTERNAL LENGTH OF THE PICC WAS 7CM. IT WAS STATED THAT THE FRACTURE CAUSED LEAKAGE OF BLOOD. A NEW CATHETER WAS PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8340943 ↗
• InjuryMay 30, 2018Material Fragmentation

  IT WAS REPORTED THAT A POWERPICC WAS PLACED ON (B)(6) 2018. IT WAS STATED THAT DURING INSERTION IT WAS DIFFICULT TO THREAD AND THE WIRE BROKE OFF. POST INSERTION X-RAY SHOWED A 3CM PIECE OF WIRE IN THE PULMONARY ARTERY. AT THE TIME OF REPORT THE WIRE WAS STILL IN THE PATIENT. ON (B)(6) 2018 - THE FACILITY REPORTED THAT "THE WIRE IS IN THE PULMONARY ARTERY AND IS NOT CAUSING HARM AT THIS TIME. IT MAY INTERFERE WITH CARE IN THE FUTURE THOUGH, I.E. NO MRIS." THE GUIDEWIRE WILL NOT BE REMOVED AS REMOVAL IS TOO DANGEROUS DUE TO THE LOCATION. IT WILL STAY IN THE PATIENT INDEFINITELY. THE FACILITY DOES NOT KNOW IF ANY TROUBLE SHOOTING MEASURES WERE ATTEMPTED OR IF THERE WERE ISSUES WITH INSERTION. PATIENT HAS PAST HISTORY OF CVC PLACEMENTS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7555243 ↗