Permcath 8815132001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521009813), received between Oct 11, 2019 and Aug 9, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE CATHETER WAS ONLY IMPLANTED FOR A FEW WEEKS, WHILE THE CATHETER WAS BEING REMOVED, THE LUMEN AND UPPER PORTION BROKE OFF FROM THE BOTTOM HALF, LEAVING THE CUFF AND DISTAL PORTION OF THE CATHETER IN THE PATIENT. THEY HAD TO CUT DOWN FURTHER THAN USUAL TO EXTRACT THE BROKEN CATHETER PIECE AND DISLODGE THE CUFF AND THERE WAS NO FURTHER ISSUE. IT WAS STATED THAT THERE WAS NO ADDITIONAL INTERVENTION REQUIRED AND THAT ALL WAS DONE AS PART OF THE SAME REMOVAL PROCESS. THEY DID NOT REQUIRE ANY DIAGNOSTIC TESTING (X-RAYS OR FLUOROSCOPY). NO EXCESSIVE FORCE WAS USED IN TAKING OUT THE CATHETER, AND THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, AND THERE WAS NO LUER ADAPTER ISSUE. IT WAS STATED THAT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY (STABLE WI TH NO ADDITIONAL ISSUES).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294372 ↗
• InjuryOct 11, 2019Break; Break

  ACCORDING TO THE REPORTER, WHEN THE CATHETER WAS RETRIEVED FROM THE VEIN AND REMOVED FROM THE PATIENT AT BEDSIDE, A FOCAL BREAKAGE FLAP OVER THE "U LOOP" AREA WAS NOTED THAT CAUSED DIFFICULTY IN REMOVAL. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, AND THERE WAS NO LUER ADAPTER ISSUE. ALCOHOL BASED AGENT (ISOPROPANOL) WAS USED AS A CLEANING AGENT ON THE DEVICE. TEGO WAS UTILIZED (TWO ONE-WAY VALVE ANTI-MICROBIAL CONNECTOR). THE EXPLANT PROCEDURE WAS CARRIED OUT BY SURGEONS THAT CREATED ADDITIONAL SURGICAL INCISIONS/WOUNDS AND THEY HAD TO CUT THE CATHETER INTO THREE PIECES FOR THE EASE OF REMOVAL. IT WAS MENTIONED THAT A CRACK WAS FOUND ON THE CATHETER NEAR THE DISTAL TIP END. ALL PIECES WERE RETRIEVED FROM THE PATIENT AND THE SURGEON CLOSED THE SURGICAL INCISION BY SUTURING. THE PATIENT DID NOT HAVE ANY COMPLICATIONS.

  Patient problems: No Code Available

  MAUDE report 9180706 ↗