Performer G09691Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00827002096912), received between Mar 14, 2016 and Jul 13, 2023 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, UPON OPENING THE PACKAGE AND FLUSHING A PERFORMER INTRODUCER PRIOR TO USE, THE USER NOTICED THAT THE TIP OF THE DILATOR WAS DAMAGED, DESCRIBING THE DAMAGE AS "CHIPPED". THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER SHEATH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE TIP OF THE DILATOR WAS NOTED TO BE SPLIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316955 ↗
• MalfunctionJan 28, 2021Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11243065 ↗
• MalfunctionJan 19, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED, UPON RECEIPT OF THREE PERFORMER INTRODUCERS, UNKNOWN SMALL WHITE PARTICLES WERE NOTED WITHIN THE PACKAGES AND ON THE SHEATHS. THE DEVICES DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11196614 ↗
• MalfunctionApr 2, 2020Fluid/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 9916799 ↗
• MalfunctionFeb 26, 2020Material 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 Patient Involvement

  MAUDE report 9757373 ↗
• MalfunctionAug 1, 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 8851832 ↗
• MalfunctionApr 11, 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 8504192 ↗
• MalfunctionApr 11, 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 8504166 ↗
• MalfunctionFeb 11, 2019Material 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 Patient Involvement

  MAUDE report 8326055 ↗
• MalfunctionAug 3, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, THE PERFORMER INTRODUCER LEAKED AT THE VALVE WHEN IT WAS INSERTED IN THE LEFT FEMORAL ARTERY FOR A SHEATH EXCHANGE DURING A THORACIC ENDOVASCULAR ANEURYSM REPAIR (TEVAR). NO OTHER DEVICES WERE BEING UTILIZED INSIDE THE COMPLAINT DEVICE AT THE TIME. A REPLACEMENT PERFORMER INTRODUCER WAS FOUND TO HAVE A BENT DILATOR AND WAS NOT USED. A THIRD SHEATH, 14FR ((B)(6)) CHECK FLO SHEATH, WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. REPORTEDLY, THE PATIENT EXPERIENCED A "LOW" AMOUNT OF BLOOD LOSS WHICH DID NOT REQUIRE ANY ADDITIONAL INTERVENTION. THE PATIENT OVERALL OUTCOME WAS REPORTEDLY "POSITIVE".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7748724 ↗
• MalfunctionDec 19, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING ULTRASOUND-GUIDED ACCESS TO THE PATIENT'S BILATERAL COMMON FEMORAL ARTERIES, THE PERFORMER INTRODUCER SHEATH WOULD NOT REMAIN SEALED AND WAS LEAKING. THE SHEATH WAS REMOVED AND REPLACED WITH ANOTHER DEVICE. THE CATHETER UTILIZED DURING THE EVENT WAS INJECTED BILATERALLY INTO THE AORTA, AND PERCUTANEOUS ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR WITH A MODULAR BIFURCATED GRAFT (TWO DOCKING LIMBS) WAS PERFORMED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME WAS REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7129214 ↗
• MalfunctionNov 28, 2017Leak/Splash; Device Inoperable; Device Operates Differently Than Expected

  SHEATH MALFUNCTION: IT WOULD NOT STAY SEALED AND LEAKED. MALFUNCTIONING SHEATH REMOVED AND REPLACED. NO ADVERSE PATIENT OUTCOME AS A RESULT OF MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7062779 ↗
• InjuryMar 14, 2016Material Separation; Material Separation

  AS PER CC FORM: IT IS A (B)(4) WITH LOT 5919694. THIS HAPPENED YESTERDAY (B)(6) 2016. DURING A FENESTRATED EVAR PROCEDURE, THE PHYSICIAN HAD INSERTED THE PERFORMER INTRODUCER IN TO THE PATIENT. WHEN THE PHYSICIAN WAS TRYING TO WITHDRAW THE DILATOR, THE HUB CAME OFF. THE PHYSICIAN HAD TO USE FORCEPS TO GET THE DILATOR OUT. ANOTHER INTRODUCER WAS USED FOR THE PROCEDURE. NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 5498508 ↗