Performer G09102Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002091023), received between Aug 14, 2017 and Jan 4, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2022Material Separation; Material Separation

  AS REPORTED, PRIOR TO USE, THE HUB SEPARATED FROM A PERFORMER MULLINS GUIDING SHEATH. THE DILATOR WAS DIFFICULT TO REMOVE AND THE HUB SEPARATED WHEN THE USER ATTEMPTED TO "UNLOCK" THE DILATOR. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13155993 ↗
• MalfunctionMay 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED 18JUN2020. AS REPORTED, THE PROCEDURE PERFORMED WAS A COVERED STENT PLACEMENT IN A STENOSED INTRA-ATRIAL FONTAN TUNNEL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THE PATIENT REQUIRED NO PROLONGED HOSPITALIZATION DUE TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10103764 ↗
• InjuryJan 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE TO EXTRACT CARDIAC LEADS, A PERFORMER MULLINS GUIDING SHEATH SEPARATED. THE LEADS WERE REPORTED TO BE IMPLANTED FOR OVER 40 YEARS. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY FOR AN IPSILATERAL APPROACH. THE PATIENT'S ANATOMY WAS NOT NOTED TO BE TORTUOUS OR CALCIFIED. A "TEFLONED" WIRE GUIDE WAS REPORTED TO BE UTILIZED THROUGH THE COMPLAINT DEVICE. WHEN THE USER ATTEMPTED TO REMOVE THE DEVICE, THE CONNECTOR DETACHED FROM THE DILATOR, LEAVING THE DILATOR INSIDE THE INTRODUCER WITH NO ABILITY TO REMOVE THE DILATOR. THE DEVICE (DILATOR AND INTRODUCER) WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS ABORTED. COMPRESSION WAS USED FOR CLOSURE. SINCE THE EVENT, THE PATIENT HAS UNDERGONE OPEN VASCULAR SURGERY TO REMOVE THE LEADS AND HAS BEEN REPORTED TO BE "DOING WELL". A SECTION OF THE COMPLAINT DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 8289794 ↗
• MalfunctionAug 14, 2017Material Separation; Material Separation

  AN INTERNATIONAL CUSTOMER REPORTED THAT WHEN THE PHYSICIAN OPENED THE PACKAGE, IT WAS NOTED THAT THE DILATOR WAS BROKEN; THE TWO PARTS OF THE DILATOR WERE SEPARATED. THE EVENT OCCURRED PRIOR TO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6791414 ↗