Performer G08133Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002081338), received between Dec 12, 2016 and Mar 24, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, UPON INSPECTION OF A PERFORMER MULLINS GUIDING SHEATH PACKAGE BY THE DISTRIBUTOR, A HAIR WAS OBSERVED INSIDE THE PRIMARY PACKAGING OF THE PRODUCT. NO ADVERSE EFFECTS WERE REPORTED AS THE DEVICE DID NOT ENTER A USER FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11564318 ↗
• MalfunctionAug 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A PERFORMER MULLINS GUIDING SHEATH LEAKED AT THE HUB. REPORTEDLY, AIR BUBBLES WERE OBSERVED AS THE USER WITHDREW FROM THE SIDE PORT, AND LEAKING WAS OBSERVED AS THE DEVICE WAS FLUSHED. 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 10441587 ↗
• MalfunctionJan 16, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  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 9595735 ↗
• MalfunctionMay 30, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED, AFTER RECEIPT OF A ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE AT THE DISTRIBUTION FACILITY, A PIECE OF HAIR WAS OBSERVED INSIDE OF THE SEALED PRIMARY PACKAGING. THIS WAS OBSERVED DURING INITIAL INSPECTION AND WAS NOT USED FOR PATIENT CARE. PER THE INITIAL REPORTER, THE COMPLAINT DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER TO AID IN THE INVESTIGATION.

  Patient problems: No Patient Involvement

  MAUDE report 8654207 ↗
• MalfunctionDec 20, 2018Material Frayed; Material Split, Cut or Torn; Material Frayed; 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 8186701 ↗
• MalfunctionOct 10, 2017Disconnection

  INTRODUCER WAS ADVANCED OVER THE STANDARD J WIRE GUIDE AS THE SHEATH WAS BEING FLUSHED AND THE SIDE ARM MANIPULATED IT BECAME SEPARATED FROM THE CFM VALVE. SIDE ARM ADAPTOR BECAME DISCONNECTED FROM THE CHECK FLOW VALVE. 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 6934789 ↗
• MalfunctionOct 9, 2017Split; Malposition of Device

  IT WAS REPORTED DURING THE PATIENT'S ELECTROPHYSIOLOGY/ABLATION PROCEDURE, UPON ADVANCING THE DILATOR INTO THE SHEATH, TRANS-THORACIC AND X-RAY IMAGING IDENTIFIED THE INTRODUCER SHEATH WAS NOT MOVING IN THE USUAL ANGLES. AS A RESULT, THE INTRODUCER WAS IMMEDIATELY REMOVED FROM THE PATIENT. SUBSEQUENTLY, THE SHEATH WAS CONFIRMED TO BE SPLIT AT THE DISTAL END BY THE DILATOR WHICH EXITED THROUGH THE SIDE OF THE SHEATH RATHER THAN THE END HOLE. AS A RESULT, THE SHEATH AND DILATOR WERE REMOVED AND EXCHANGED. IT WAS NOTED THAT NO HARM WAS CAUSED TO THE PATIENT AS TRANS-THORACIC ECHO REVEALED NO DAMAGE/EFFUSION. ADDITIONALLY, IT WAS NOTED THE DILATOR AND SHEATH WERE FLUSHED AND PREPARED BEFORE BEING ADVANCED INTO THE PATIENT. ALSO, IT WAS CLARIFIED THAT UPON DETERMINING THE SHEATH WAS NOT IN THE CORRECT PLACE, THE DILATOR WAS REMOVED, RE-INTRODUCED AND UPON RE-IMAGING THE ISSUE WITH THE DILATOR AND SHEATH WAS IDENTIFIED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6932049 ↗
• MalfunctionOct 9, 2017Device Operates Differently Than Expected

  THE PHYSICIAN REPORTED THAT THE WIRE WOULD NOT GO THROUGH THE DILATOR. NO PART OF THE DEVICE WAS LEFT IN THE PATIENT'S BODY, AND THERE WERE NO INJURIES OR ADDITIONAL MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6931800 ↗
• MalfunctionDec 12, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A TRANSSEPTAL PUNCTURE TO PERFORM AN ATRIAL FIBRILLATION ABLATION, THE PHYSICIAN NOTICED AIR ENTERING THE SHEATH. THE SHEATH WAS WITHDRAWN AND A NEW REPLACEMENT DEVICE WAS USED. 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 6165789 ↗