Performer G09210Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00827002092105), received between Aug 18, 2016 and Jul 31, 2023 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424821 ↗
• MalfunctionJan 20, 2023Fluid/Blood Leak; Device Dislodged or Dislocated; Fluid/Blood Leak; Device Dislodged or Dislocated

  AS REPORTED, DURING A PROCEDURE INVOLVING COARCTATION STENTING, A PERFORMER MULLINS GUIDING SHEATH LEAKED FROM THE VALVE. THE SHEATH WAS PLACED ACROSS THE DEFECT AND WHILE ADVANCING A BALLOON OVER A WIRE GUIDE, THE VALVE "GAVE WAY", RESULTING IN LEAKAGE OF BLOOD. RESISTANCE WAS ENCOUNTERED UPON INSERTION AND REMOVAL OF OTHER DEVICES THROUGH THE VALVE. BLEEDING WAS STOPPED BY IMMEDIATELY REMOVING AND REPLACING THE DEVICE WITH A NEW SHEATH, WHICH WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY INTERVENTION TO TREAT BLOOD LOSS AND REMAINED HEMODYNAMICALLY STABLE. ANOTHER PERFORMER MULLINS GUIDING SHEATH FROM ANOTHER LOT ALSO LEAKED DURING THE SAME PROCEDURE; THIS EVENT WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6). THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16215734 ↗
• MalfunctionJan 20, 2023Fluid/Blood Leak; Device Dislodged or Dislocated; Fluid/Blood Leak; Device Dislodged or Dislocated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16215721 ↗
• MalfunctionDec 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12933052 ↗
• MalfunctionNov 3, 2021Material Frayed; Deformation Due to Compressive Stress; Sharp Edges; Material Frayed; Deformation Due to Compressive Stress; Sharp Edges

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12747394 ↗
• MalfunctionJul 7, 2021Fluid/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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12129733 ↗
• MalfunctionOct 23, 2020Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10727364 ↗
• MalfunctionOct 14, 2019Contamination /Decontamination Problem; Detachment of Device or Device Component; Contamination /Decontamination Problem; Detachment of Device or Device Component

  UPON RETURN AND INITIAL EVALUATION OF THE DEVICE ON (B)(6) 2019, THREE DARK FOREIGN MATTER FIBERS WERE NOTED BY THE DISTAL SEAL OF THE INNER POUCH. ONE WAS WITHIN THE SEAL AND TWO WERE FREE-FLOATING.

  Patient problems: No Patient Involvement

  MAUDE report 9187039 ↗
• MalfunctionJul 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Patient Involvement

  MAUDE report 8796749 ↗
• MalfunctionOct 30, 2018Material Separation; Material Separation

  IT WAS REPORTED DURING "MELODY VALVE PLACEMENT VIA RIGHT INTERNAL JUGULAR VEIN" PROCEDURE, TWO PERFORMER MULLINS GUIDING SHEATHS DISCONNECTED AT THE HUB. THE PROCEDURE INVOLVED A (B)(6) MALE WITH A HISTORY OF PULMONARY VALVE INSUFFICIENCY AND A PRIOR HISTORY OF MELODY VALVE PLACEMENT AND REPEATED RIGHT NECK ACCESS. ACCORDING TO THE INITIAL REPORTER, THE FIRST SHEATH (REFERENCE REPORT 1820334-2018-03180) WAS ADVANCED OVER ANOTHER MANUFACTURER'S WIRE GUIDE AND, SOON AFTER, THE WHITE HUB ON THE DILATOR SEPARATED. THE COMPLAINT DEVICE WAS EXCHANGED FOR ANOTHER PERFORMER MULLINS GUIDING SHEATH (REFERENCE THIS REPORT), AND THE HUB DISCONNECTED ON THIS DEVICE AS WELL. THE PATIENT WAS SAID TO HAVE TORTUOUS ANATOMY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE, NOTING THAT THERE WAS MORE BLOOD LOSS THAN USUAL; HOWEVER, NO TRANSFUSIONS WERE REQUIRED AS A RESULT. THE PROCEDURE WAS REPORTED TO BE SUCCESSFUL. 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 8019669 ↗
• MalfunctionJul 25, 2018Material 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 7718075 ↗
• InjuryJun 19, 2018Detachment Of Device Component; Detachment Of Device Component

  ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. THIS INFORMATION IS DETAILED.

  Patient problems: No Code Available

  MAUDE report 7616053 ↗
• InjuryMar 29, 2018Kinked; Kinked

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY, THE 14 FR PERFORMER MULLINS GUIDING SHEATH WAS USED TO INTRODUCE AN 8 FR BALLOON VALVE AND TO PLACE A STENT; INTRODUCTION OF THE BALLOON OCCURRED WITHOUT ISSUES. THE PATIENT'S LESION WAS LOCATED IN THE PULMONARY ARTERY AND THE COURSE WAS TORTUOUS. THE PHYSICIAN WAS ABLE TO ADVANCE THE BALLOON, BUT WAS UNABLE TO REMOVE THE BALLOON FROM THE SHEATH AFTER DILATION OF THE ARTERY, AND HAD TO REMOVE THE ENTIRE SYSTEM FROM THE PATIENT'S ANATOMY. THE SHEATH WAS OBSERVED TO HAVE SEVERAL FOLDS THAT PREVENTED THE ANGIOPLASTY FROM BEING COMPLETED. AS A RESULT OF THE SHEATH FOLDS/ KINKING, THE PHYSICIAN WAS REQUIRED TO RE-SCHEDULE THE STENT IMPLANTATION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT ANATOMY HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 7381464 ↗
• MalfunctionFeb 5, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED PROCEDURE UPON OPENING THE PACKAGE, THE PERFORMER MULLINS GUIDING SHEATH HUB WAS OBSERVED TO BE DETACHED. THE DEVICE DID NOT COME INTO CONTACT WITH A PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7242425 ↗
• MalfunctionJun 6, 2017Material Separation; Material Separation

  IT WAS REPORTED DURING AN UNSPECIFIED PROCEDURE THAT WHILE USING A PERFORMER MULLINS GUIDING SHEATH THE PHYSICIAN FELT THE SHEATH WAS BENT HOWEVER HE STILL ATTEMPTED TO USE IT. DURING INSERTION, THE HUB SEPARATED. ANOTHER DEVICE FROM THE SAME LOT WAS PULLED OFF THE SHELF AND WAS VISIBLY NOTED TO BE BENT. THE DEVICE WAS REMOVED FROM THE PACKAGING AND DURING EXAMINATION, THE HUB EASILY SEPARATED. A THIRD DEVICE WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6615485 ↗
• MalfunctionMay 12, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT WHILE PERFORMING A MELODY VALVE PROCEDURE USING A PERFORMER MULLINS GUIDING SHEATH, THE HUB OF THE DILATORS BROKE OFF. THIS HAPPENED TWICE IN THE SAME CASE. THE FIRST DEVICE BROKE WHEN THE SCRUB WAS ASSEMBLING IT. THE SECOND DEVICE BROKE WHEN THE PHYSICIAN WAS REMOVING THE SHEATH FROM THE PATIENT. THIS MEDWATCH IS FOR THE FIRST DEVICE. PLEASE SEE MEDWATCH WITH MFR REPORT NUMBER 1820334-2017-00957 FOR THE SECOND DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6563183 ↗
• MalfunctionMay 11, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT WHILE PERFORMING A MELODY VALVE PROCEDURE USING A PERFORMER MULLINS GUIDING SHEATH, THE HUB OF THE DILATOR BROKE OFF. THIS HAPPENED TWICE IN THE SAME CASE. THE FIRST DEVICE BROKE WHEN THE SCRUB WAS ASSEMBLING IT. THE SECOND DEVICE BROKE WHEN THE PHYSICIAN WAS REMOVING THE SHEATH FROM THE PATIENT. THIS MEDWATCH IS FOR THE SECOND DEVICE. PLEASE SEE MEDWATCH WITH MANUFACTURE REPORT NUMBER 1820334-2017-00956 FOR THE FIRST DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6562026 ↗
• InjuryAug 18, 2016Break; Torn Material; Break; Torn Material

  INFORMATION WAS PROVIDED THAT A MALE PATIENT UNDERWENT A STENT AORTIC IMPLANT PROCEDURE. DURING THE PROCEDURE, AFTER PASSING THE SHEATH WITHOUT ANY DIFFICULTY BY THE RIGHT INGUINAL REGION IN AN ATTEMPT TO REMOVE THE DILATOR, THERE WAS A CIRCUMFERENTIAL AND COMPLETE BREAK OF THE HUB. IT WAS POSSIBLE TO REMOVE THE DILATOR FROM INSIDE THE SHEATH WITH TWEEZERS, BUT THERE WAS A LITTLE LOSS OF BLOOD. ALSO, THE EXTRA-STIFF GUIDE THAT WAS PARKED IN THE RIGHT SUBCLAVIAN ARTERY HAD DOUBLED AND HAD TO BE CHANGED TO CONTINUE WITH THE PROCEDURE THAT WAS FINISHED WITHOUT DIFFICULTIES. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 5885169 ↗