Performer G09190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002091900), received between Jan 28, 2019 and May 14, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2020Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE INVOLVING OCCLUSION OF THE "CIA", ANOTHER MANUFACTURER'S OCCLUDER WAS DIFFICULT TO REMOVE FROM A KINKED PERFORMER MULLINS GUIDING SHEATH. THE SHEATH WAS PREPARED PER THE INSTRUCTIONS FOR USE AND WAS USED AS A GUIDE FOR THE OCCLUSION DEVICE. THE DEVICE WAS REPORTEDLY REPOSITIONED AFTER THE FIRST RELEASE; HOWEVER UPON THE SECOND ATTEMPT IT WAS NOT POSSIBLE TO REINSERT THE DEVICE INTO THE SHEATH. THE SHEATH BECAME "DEFORMED WITH TWISTING ON ITS OWN AXIS" AND THE DIAMETER BECAME DIMINISHED. THE OCCLUDER WAS REMOVED WITH DIFFICULTY AND INSERTED INTO A LARGER SHEATH. ANOTHER MANUFACTURER'S SHEATH WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 10057028 ↗
• MalfunctionFeb 28, 2019Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. THIS INFORMATION IS DETAILED IN SECTION H10.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8379545 ↗
• MalfunctionJan 28, 2019Material Separation; Material Separation

  IT WAS REPORTED, A PERFORMER MULLINS GUIDING SHEATH WAS ADVANCED OVER AN UNSPECIFIED WIRE GUIDE INTO A PATIENT'S ANATOMY. PROCEDURE AND INSERTION SITE WERE NOT PROVIDED. THE PHYSICIAN FELT RESISTANCE AND DECIDED TO REMOVE THE PERFORMER MULLINS GUIDING SHEATH. UPON REMOVAL, THE COMPLAINT DEVICE WAS "SHEARED" FROM THE TIP TO "5CM UP THE SHAFT". NO PORTION REMAINED IN THE PATIENT'S ANATOMY. A SECOND PERFORMER MULLINS GUIDING SHEATH WAS ADVANCED OVER THE GUIDE WIRE AND AN UNSPECIFIED BALLOON CATHETER WAS INTRODUCED THROUGH IT. THIS SHEATH ALSO "SHEARED" AND WAS REMOVED FROM THE PATIENT'S ANATOMY ALONG WITH THE BALLOON CATHETER. NO PORTION OF THIS SECOND COMPLAINT SHEATH REMAINED IN THE PATIENT'S ANATOMY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE BOTH PERFORMER MULLINS GUIDING SHEATHS WERE FROM THE SAME LOT. ALTHOUGH REQUESTED, PATIENT DEMOGRAPHICS AND ADDITIONAL EVENT DETAILS WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8281401 ↗