Performer G13495Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002134959), received between Aug 8, 2014 and Jun 28, 2017 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2017Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  AS REPORTED TO CUSTOMER RELATIONS, THE PERFORMER INTRODUCER APPEARED TO BE LEAKING BLOOD OUT OF THE VALVE DURING THE PROCEDURE. ADDITIONAL INTERVENTION OR PROCEDURES WERE NOT CONDUCTED, AND NO ADVERSE EVENTS HAVE YET TO BE REPORTED.

  Patient problems: No Information

  MAUDE report 6672662 ↗
• MalfunctionJun 27, 2017Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  AS REPORTED TO CUSTOMER RELATIONS, THE PERFORMER INTRODUCER APPEARED TO BE LEAKING BLOOD OUT OF THE VALVE DURING THE PROCEDURE. ADDITIONAL INTERVENTION OR PROCEDURES WERE NOT CONDUCTED, AND NO ADVERSE EVENTS HAVE YET TO BE REPORTED.

  Patient problems: No Information

  MAUDE report 6670890 ↗
• InjuryMar 23, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A FISTULOGRAM OF THE LEFT ARM USING A PERFORMER INTRODUCER, THE SHEATH SHEARED OFF INSIDE THE PATIENT'S ARM. ADDITIONAL EVENT DETAILS PROVIDED BY THE COOK DISTRICT MANAGER WAS THAT "THE ATTENDING PHYSICIAN STATED THAT THE FELLOW BENT THE SHEATH WHILE IT WAS INSIDE OF THE PATIENT WHICH CAUSED A PIECE OF IT TO BREAK OFF. THE ATTENDING PHYSICIAN ALSO STATED THAT THERE WAS NOTHING WRONG WITH THE SHEATH, BUT RATHER THE FELLOW MADE A MISTAKE IN HANDLING THE SHEATH. THE SHEATH HAD TO BE SNARED THRU THE PATIENT'S GROIN. THERE WAS NO UNINTENDED SECTION OF THE DEVICE LEFT INSIDE OF THE PATIENT. IT WAS REPORTED THAT THERE WERE NO ISSUES WITH THE WIRE OR ANY OTHER INSTRUMENTS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6427673 ↗
• MalfunctionDec 7, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THE PERFORMER INTRODUCER VALVE WAS LEAKING DURING THE PROCEDURE. THE DEVICE WAS EXCHANGED DURING THE PROCEDURE WITH A DEVICE THAT WORKS PROPERLY. THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES NOR EXPERIENCE ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6151372 ↗
• MalfunctionDec 7, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THE PERFORMER INTRODUCER VALVE WAS LEAKING DURING THE PROCEDURE. THE DEVICE WAS EXCHANGED DURING THE PROCEDURE. THE PATIENT HAD NO ADVERSE CONSEQUENCE DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6151023 ↗
• InjuryAug 8, 2014Material Separation

  DURING A FISTULOGRAM W/PLASTY PROCEDURE, THE COOK 6FR DIALYSIS SHEATH BROKE OFF TAT THE HUB INSIDE THE PATIENT. THE ATTENDING PHYSICIAN HAD PUT THE DORADO BALLOON IN THE SHEATH AND INTO THE ARM AND BLEW IT UP ONE TIME. THE BALLOON WAS THEN DEFLATED, REMOVED, AND THEN THE BALLOON WAS PUT BACK IN. WHEN THE BALLOON WAS REINSERTED, THE HUB AND BLUE PORTION OF THE SHEATH SEPARATED; LEAVING THE BLUE PORTION STUCK ON THE BALLOON, INSIDE THE BODY OF THE PATIENT. THIS WAS REALIZED WHEN THE USER WENT TO INFLATE THE BALLOON AND NOTICED THAT SOMETHING WAS RESTRICTING IT FROM BEING INFLATED. IT TOOK SEVERAL HOURS AND 3 ATTENDINGS TO REMOVE THE BLUE PORTION OF THE SHEATH. THE BLUE PART OF THE SHEATH WAS INSIDE THE PATIENT; ALONG WITH THE WIRE. THEREFORE, THEY PUT A LARGER 10FRENCH SHEATH INSIDE, UP AGAINST THE PIECE, THEN PUT A SNARE IN AND SNARED THE BLUE PIECE AND PULLED IT OUT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NO EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. HOWEVER, IT DID REQUIRE 3 ATTENDINGS HELP TO REMOVE THE PIECE THAT HAD BROKEN OFF DURING THE CASE.

  Patient problems: Foreign body, removal of

  MAUDE report 4017947 ↗