Performer G10675Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00827002106758), received between Nov 2, 2016 and Nov 27, 2019 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2019Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9385282 ↗
• MalfunctionOct 31, 2019Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9259878 ↗
• MalfunctionOct 2, 2019Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9146005 ↗
• MalfunctionSep 30, 2019Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9135668 ↗
• InjuryNov 16, 2017Leak/Splash; Leak/Splash

  DURING A DIALYSIS/FISTULOGRAM PROCEDURE, THE PHYSICIAN GAINED ACCESS INTO THE PATIENT'S LEFT BRACHIAL VEIN WITH A MICROPUNCTURE FIVE (5) FR CATHETER FROM ANOTHER MANUFACTURER. THIS 5 FR MICROPUNCTURE CATHETER WAS ADVANCED, AND BOTH A LEFT BRACHIAL AND LEFT SUBCLAVIAN ANGIOGRAM WERE PERFORMED. ANOTHER MANUFACTURER'S GLIDEWIRE ANGLED (0.035 INCHES, 180 CENTIMETERS (CM)) WAS INSERTED. A COOK MEDICAL MANUFACTURED CHECK-FLO PERFORMER INTRODUCER SIX (6) FR GAUGE WAS INSERTED INTO THE LEFT BRACHIAL VEIN AND ADVANCED, AND THE 5 FR MICROPUNCTURE CATHETER WAS REMOVED. THE CHECK-FLO PERFORMER INTRODUCER REPORTEDLY HAD A DEFECTIVE VALVE WHICH ALLOWED BLOOD LOSS FROM THE DIALYSIS FISTULA, AND WAS REPLACED IMMEDIATELY FOLLOWING INSERTION. AN OVER THE WIRE (OTW) BALLOON (NOT MANUFACTURED BY COOK MEDICAL) WAS INSERTED IN THE FISTULA. THE OTW BALLOON WAS INFLATED TO 6 ATMOSPHERE (ATM) FOR 120 SECONDS, A FISTULA ANGIOGRAM WAS MANUALLY INJECTED, AND THE OTW BALLOON WAS REMOVED. THE PROCEDURE WAS ABLE TO BE COMPLETED, AND THE PHYSICIAN STATED THAT THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT LOST APPROXIMATELY TEN (10) MILLILITERS (ML) OF BLOOD; NO INTERVENTION WAS REQUIRED AS A RESULT. DURING THE

  Patient problems: Blood Loss

  MAUDE report 7039274 ↗
• MalfunctionSep 5, 2017Leak/Splash; Leak/Splash

  A PERFORMER INTRODUCER WAS USED IN A FISTULOGRAM PROCEDURE IN THE ARM. IT WAS REPORTED THAT, WHEN TRYING TO ADVANCE THE GUIDE WIRE THROUGH THE VALVE, THE VALVE WAS LEAKING. THE PHYSICIAN REPLACED THE SHEATH AND COMPLETED THE PROCEDURE WITHOUT ISSUE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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 Known Impact Or Consequence To Patient

  MAUDE report 6842737 ↗
• MalfunctionAug 8, 2017Detachment Of Device Component

  BEFORE PATIENT CONTACT AND PRIOR TO THE PROCEDURE, THE FACILITY OPENED TWO DEVICES OF THE SAME LOT AND NOTICED THE SHEATH PULLS AWAY WHERE IT CONNECTS TO THE HUB. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME KIND (LOT NUMBER UNKNOWN). 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 Known Impact Or Consequence To Patient

  MAUDE report 6774354 ↗
• MalfunctionAug 3, 2017Detachment Of Device Component; Difficult to Remove

  DURING AN ANGIOPLASTY PROCEDURE USING ARM ACCESS. THE USER ATTEMPTED TO REMOVE THE BALLOON FROM THE SHEATH AND THE SHEATH PULLED AWAY AND SEPARATED FROM THE HUB. TWO MORE DEVICES WERE REPORTED TO HAVE THE SAME DIFFICULTY. ULTIMATELY, A FOURTH DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. 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 Consequences Or Impact To Patient

  MAUDE report 6765507 ↗
• InjuryJul 28, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT A PERFORMER INTRODUCER WAS USED DURING AN UNSPECIFIED PROCEDURE. THE HUB DISCONNECTED FROM THE SHEATH AND THE SHEATH MIGRATED INSIDE THE PATIENT'S BODY. THE USER HAD TO CREATE A NEW INCISION IN THE NECK TO RETRIEVE THE SHEATH. FORCEPS WERE USED TO REMOVE THE SHEATH. THERE WERE NO REPORTED ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6750326 ↗
• MalfunctionJul 21, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PERFORMER INTRODUCER WAS USED FOR INSERTING A DIALYSIS INTRODUCER. IT WAS DISCOVERED THAT THE DEVICE IS LEAKING FROM THE HUB. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6734294 ↗
• MalfunctionApr 28, 2017Leak/Splash; Leak/Splash

  AS STATED BY THE REPORTER: ON (B)(6) 2015 DURING THREE FISTULA GRAM CASES, TWO OF THE THREE COOK SHEATHS USED FROM THE SAME LOT LEAKED EXCESSIVELY. THE EVENT OCCURRED AFTER THE PHYSICIAN PULLED THE DILATOR OUT OF THE SHEATH OVER A .035 GLIDE WIRE (ANOTHER MANUFACTURER). THIS WOULD RESULT IN A STEADY DRIP AND THE USE OF ANOTHER SHEATH. NO HARM TO PATIENTS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6530974 ↗
• MalfunctionApr 28, 2017Leak/Splash; Leak/Splash

  CUSTOMER REPORTED THAT A PATIENT WAS SCHEDULED FOR AN UNSPECIFIED PROCEDURE. CUSTOMER STATES THAT THE PRODUCT LEAKS AT THE CHECK FLO VALVE WHEN FLUSHED PRIOR TO THE PROCEDURE. THERE WAS NO REPORTED DEVICE CONTACT WITH THE PATIENT, AND ACCORDINGLY THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6530437 ↗
• MalfunctionMar 20, 2017Leak/Splash; Leak/Splash

  PER MEDSUN REPORT (B)(4): IT WAS REPORTED THAT THE (B)(6) FEMALE PATIENT WAS UNDERGOING A BALLOON ANGIOPLASTY PROCEDURE. THE VASCULAR SHEATH WAS INSERTED INTO AN UNSPECIFIED ARM WHEN LEAKAGE WAS NOTED. AN UNSPECIFIED DEVICE WAS BEING UTILIZED THROUGH THE SHEATH. A 0.035 WIRE WAS INSERTED INTO THE LUMEN OF THE SHEATH PRIOR TO REMOVAL. THE SHEATH WAS CHANGED OUT WITH NO FURTHER INCIDENT. THE PATIENT'S ANATOMY WAS REPORTEDLY NOT TORTUOUS NOR CALCIFIED. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. PER THE REPORT, A SIMILAR EVENT HAPPENED PREVIOUSLY IN (B)(6) 2015 (REFERENCING 1820334-2015-00876).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6417181 ↗
• InjuryNov 2, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO CUSTOMER RELATIONS THAT A PIECE OF AN INTRODUCER MAY HAVE CAME OFF INSIDE A PATIENT. THE ORIGINAL CALL WAS AN INQUIRY AS TO ANY PRODUCT RECALL INFORMATION FROM THE FACILITIES RISK MANAGEMENT DEPARTMENT. WHEN ASKED FOR MORE DETAILS INTO THE ALLEGED INCIDENT THE CUSTOMER WANTED TO RESCIND THE COMPLAINT INFORMATION AS HE STATED HE HAS NOT CONFIRMED THE INCIDENT. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION. AS OF THE DATE OF THIS REPORT NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6072326 ↗