Performer G12664Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002126640), received between Jul 13, 2020 and Apr 23, 2025 — classified as 2 injuries, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A LOWER EXTREMITY ARTERIOGRAM WITH BALLOON DILATION VIA THE FEMORAL ARTERY, THE HUB OF A PERFORMER INTRODUCER SEPARATED FROM THE DEVICE. THE PATIENT HAD A HISTORY OF ARTERIOSCLEROSIS AND OCCLUSIVE DISEASE OF THE LOWER EXTREMITIES (FONTAINE STAGE IV). AFTER THE HUB SEPARATED, THE SHAFT OF THE DEVICE ¿FELL¿ INTO THE PATIENT¿S FEMORAL ARTERY AND WAS UNABLE TO BE REMOVED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR SURGICAL REMOVAL OF THE SHAFT. THE SHAFT WAS SUCCESSFULLY REMOVED DURING THE ¿SECOND¿ SURGICAL PROCEDURE. A PHOTO PROVIDED BY THE CUSTOMER SHOWS HUB SEPARATION. THE SHAFT MATERIAL ALSO APPEARS TO HAVE BEEN CUT OR PARTIALLY TORN. A SECTION OF THE 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 EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21889758 ↗
• MalfunctionDec 11, 2024Unraveled Material; Unraveled Material

  IT WAS ORIGINALLY REPORTED THAT PRIOR TO USE FOR AN UNKNOWN PROCEDURE THE USER FOUND THE WIRE GUIDE OF A PERFORMER INTRODUCER WAS BENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER UNSPECIFIED NEW DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. UPON PRELIMINARY EVALUATION OF THE RETURNED DEVICE ON 02DEC2024, IT WAS NOTED THAT WIRE GUIDE HAD UNRAVELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20906470 ↗
• MalfunctionDec 9, 2020Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, PRIOR TO PATIENT CONTACT DURING A "TASE" PROCEDURE, A HOLE OR SEPARATION WAS NOTED BETWEEN THE PERFORMER INTRODUCER SHEATH AND HUB. AS THE USER ATTEMPTED TO INSERT THE DILATOR, IT DID NOT ENTER THE LUMEN OF THE SHEATH, BUT RATHER CAME OUT BETWEEN THE HUB AND SHEATH MATERIAL. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT, AND ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10975463 ↗
• InjuryJul 13, 2020Material Separation; Material Separation

  AS REPORTED, DURING AN ATTEMPTED PLACEMENT OF ANOTHER MANUFACTURER'S PERMCATH IN A PATIENT WITH AN AV FISTULA, A PERFORMER INTRODUCER SEPARATED IN THE PATIENT. THE INTRODUCER WAS HANDLED USING LATEX GLOVES AND FLUSHED WITH SALINE SOLUTION PRIOR TO USE. THE INTRODUCER WAS INSERTED INTO THE LEFT NECK OVER A GUIDE WIRE INCLUDED WITH THE PERMCATH. DURING REMOVAL OF THE INTRODUCER, THE DEVICE SEPARATED. A CUT-DOWN WAS PERFORMED TO EXPOSE THE VESSEL, AND A SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE SEPARATED DEVICE PIECE FROM THE PATIENT. THE PATIENT'S ANATOMY WAS NOT CALCIFIED OR TORTUOUS. A SECTION OF THE 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 10263974 ↗