Performer G07338Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002073388), received between Jan 8, 2015 and Jul 10, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2023Packaging Problem; Packaging Problem

  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 17289345 ↗
• MalfunctionSep 9, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, THE TIP OF A PERFORMER INTRODUCER SPLIT. BEFORE BEGINNING THE PROCEDURE, THE USER FOUND A SMALL GAP BETWEEN THE INTRODUCER AND THE DILATOR, BUT STILL ATTEMPTED TO GAIN ACCESS THROUGH THE COMMON FEMORAL ARTERY WITH THE DEVICE. THE USER ENCOUNTERED DIFFICULTY GAINING ACCESS AND FOUND THE TIP OF THE SHEATH SPLIT. ANOTHER SAME TYPE DEVICE WAS USED TO FINISH THE PROCEDURE. NO PORTION OF THE DEVICE WAS LEFT WITHIN THE PATIENT. THERE WAS NO NEED FOR ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12445898 ↗
• MalfunctionMar 5, 2021Material 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 11420640 ↗
• InjuryApr 8, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, A PERFORMER INTRODUCER WAS "BROKEN/MISSHAPEN" AND CAUSED A SMALL TEAR IN THE PATIENT'S ARTERY. REPORTEDLY, THE DAMAGE WAS FOUND FROM THE PACKAGE; HOWEVER, WAS NOT OBSERVED BY THE SCRUB NURSE UNTIL THE PHYSICIAN USED THE DEVICE. THE PLASTIC WAS "BROKEN/MISSHAPEN" WHERE THE DILATOR MEETS THE SHEATH. THE ORIGINAL PROCEDURE INVOLVED A CUT-DOWN; THEREFORE, THE TORN ARTERY WAS REPAIRED USING SUTURES. 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 9934452 ↗
• MalfunctionJan 8, 2015Leak/Splash

  (B)(6) FOLLOWED THE IFU TO USE THE PERFORMER INTRODUCER. THE DOCTOR INSERTED THE INTRODUCER WITH DILATER INTO PT'S BODY, AND WHEN HE TOOK OUT THE DILATER, HE FOUND OUT THAT BLOOD LEAK FROM THE CHECK-FLO OF THE INTRODUCER. SO HE CAN'T USE IT ANYMORE BECAUSE OF THE BLOOD LEAKAGE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 4417549 ↗