Performer G12782Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002127821), received between Jun 12, 2017 and Jan 25, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 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.

• MalfunctionJan 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, A (B)(6) FEMALE WITH PAST MEDICAL HISTORY OF TETRALOGY OF FALLOT (PREVIOUSLY REPAIRED) AND A CHROMOSOMAL ABNORMALITY UNDERWENT A PERCUTANEOUS PULMONARY VALVE REPLACEMENT WITH PRE-STENTING OF THE RIGHT VENTRICULAR OUTFLOW TRACT PROCEDURE. THE PATIENT'S ANATOMY WAS DESCRIBED AS "NOT OUT OF THE ORDINARY FOR A PATIENT WITH A REPAIRED TETRALOGY OF FALLOT". DURING THE PROCEDURE, ACCESS WAS GAINED VIA THE FEMORAL VEIN. THE PERFORMER MULLINS GUIDING SHEATH WAS BEING ADVANCED OVER A GUIDEWIRE (MANUFACTURER NOT SPECIFIED) INTO POSITION IN THE RIGHT VENTRICLE WHEN THE WHITE HUB BROKE OFF WHILE TRYING TO ADVANCE IT INTO THE MAIN PULMONARY ARTERY. PER THE PHYSICIAN, ESTIMATED BLOOD LOSS WAS 10ML SO NO TRANSFUSION WAS REQUIRED. THE COMPLAINT DEVICE WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. ACCORDING TO THE COMPLAINANT, NO PORTION OF THE DEVICE REMAINED IN THE PATIENT'S ANATOMY. THERE WERE NO ADVERSE EFFECTS AND NO ADDITIONAL PROCEDURES REQUIRED AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8278563 ↗
• MalfunctionJun 12, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT A PERFORMER MULLINS GUIDING SHEATH WAS USED IN A PROCEDURE TO CORRECT COARCTATION OF THE AORTA. DURING THE PROCEDURE THE HANDLE OF THE DILATOR, THE INNER PART OF THE SHEATH BROKE. THE REPORTED DEVICE THAT WAS BEING UTILIZED THROUGH THE SHEATH WAS A PAVTI-EDWARDS SAPIEN. SEPARATION OCCURRED DURING INSERTION INTO THE PATIENT'S LEG. THE PATIENT'S ANATOMY WAS NEITHER TORTUOUS OR CALCIFIED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY AND THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6633286 ↗