ProTrack Pigtail Wire PTW-25-230Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00685447001010), received between Aug 6, 2019 and May 26, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE RECORDED A CODE 1003, INDICATING THE VOLTAGE IS TOO LOW FOR THE PROJECTED REMAINING CAPACITY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS IDENTIFIED POTENTIAL HIGH IMPEDANCE WITHIN THE BATTERY. CONTINUED MONITORING WAS RECOMMENDED. THE DEVICE STILL REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25286037 ↗
• MalfunctionSep 18, 2025Difficult to Insert; Nonstandard Device; Physical Resistance/Sticking; Difficult to Insert; Nonstandard Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A FARAPULSE PROCEDURE INDICATED FOR ATRIAL FLUTTER (AF), A PROTRACK PIGTAIL WIRE WAS SELECTED FOR USE. THE PHYSICIAN COULD NOT GET THE WIRE TO MOVE IN THE CHEATER/INSERTION TOOL DIRECTLY OUT OF THE PACKAGE. THE ISSUE WAS NOTED WHILE ADVANCING THE INSERTION TOOL OVER THE PIGTAIL. WHILE USING HEMOSTATS TO DISLODGE, THE STUCK WIRE SPLASHED HIMSELF IN THE EYE WITH BLOOD. THE BLOOD SPLASH WAS FROM HIS HANDS, THAT CAME FROM THE GROIN INITIALLY. THE PHYSICIAN WAS ABLE TO GET IT UNSTUCK AND UTILIZE THE WIRE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE WAS NOT INSERTED INTO A METAL TOOL. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23090184 ↗
• InjuryApr 14, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A PROTRACK GUIDEWIRE WAS SELECTED FOR USE. AFTER TRANSEPTAL CROSSING UNDER INTRACARDIAC ECHOCARDIOGRAPHY (ICE) GUIDANCE USING NON-BOSTON SCIENTIFIC MECHANICAL NEEDLE AND PREFACE SHEATH. THE PHYSICIAN THEN REMOVED THE NEEDLE AND INSERTED THE PROTRACK WIRE IN ORDER TO EXCHANGE TO WATCHMAN SHEATH. AFTER INSERTING THE WIRE, THE PHYSICIAN DIDN'T FEEL RIGHT AND WAS ATTEMPTED TO REMOVE IT. IT WAS NOTED THAT THE WIRE APPEARED TO HAVE UNRAVELED AND WAS ONLY ATTACHED BY A VERY NARROW THREAD. IT APPEARED UNDER IMAGING TO BE ACROSS THE SEPTUM AND THROUGH THE MITRAL VALVE. THE PHYSICIAN ATTEMPTED TO SNARE THE WIRE AND WAS ABLE TO REMOVE MULTIPLE PORTIONS BUT NEVER THE WHOLE WIRE. THE REMAINING PORTIONS WERE STILL VISIBLE IN INFERIOR VENA CAVA (IVC), RIGHT AND LEFT ATRIUM. THE PATIENT WAS SENT TO SURGERY TO REMOVE THE REST OF THE WIRE ENTERALLY. LATER WAS, THE PATIENT WAS DOING WELL, AND IT WAS DISCHARGED. THE DEVICE IS NOW EXPECTED TO BE RETURNED FOR ANALYSIS. THE TECH WHO PREPPED THE WIRE SAID NOT VIABLE DAMAGE WAS NOTED PRIOR TO USE IT.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 21836671 ↗
• MalfunctionNov 5, 2024Defective Device; Material Deformation; Defective Device; Material Deformation

  IT WAS REPORTED THAT A PROTRACK PIGTAIL WIRE WAS SELECTED FOR USE DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). PRIOR TO THE PROCEDURE, THE WIRE WAS HANDED OFF AND UPON OPENING PACKAGING THE WIRE WAS KINKED, AND IT WAS NOTICED THAT PIGTAIL SHAPE WAS UNRAVELED. HENCE, THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (RETAINED BY CUSTOMER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20615526 ↗
• MalfunctionFeb 26, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT A PROTRACK PIGTAIL WIRE HAS ARRIVED DAMAGED. IT WAS REPORTED THAT THE PACKAGING AND PRODUCT ARRIVED AT THE FACILITY DAMAGED; THE PROTRACK PACKAGING LOOKED FOLDED IN MULTIPLE LOCATIONS AND THE ENDS OF THE BOX WHERE THE TAB IS TO KEEP THE BOX SHUT IS RIPPED; STERILE PACKAGING WAS DEEMED NOT COMPROMISED. NO PATIENT INVOLVEMENT WAS REPORTED. IT WAS FURTHER EVALUATED DURING ANALYSIS (05FEB2024) THAT BASED ON PHOTOS PROVIDED, THAT THE PACKAGING IS DAMAGED, AND INTEGRITY OF DEVICES IS IN DOUBT. A VISUAL INSPECTION WAS CONDUCTED BASED ON THE PHOTOS SUBMITTED, AND IT WAS NOTED THAT THE RE-PACK SHIPPER IDENTIFIED DAMAGED AT ONE END AS WELL AS MULTIPLE CREASES IDENTIFIED OVERALL. ALSO, A DAMAGE HAS BEEN IDENTIFIED IN THE CATON, THE INTEGRITY OF THE DEVICE AND STERILE BARRIER SYSTEM IS IN DOUBT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18785559 ↗
• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE NRG TRANSSEPTAL NEEDLE, PROTRACK PIGTAIL WIRE AND TORFLEX TRANSSEPTAL GUIDING SHEATH WERE USED IN A PROCEDURE. A PERICARDIAL EFFUSION OCCURRED AT THE END OF THE PROCEDURE. DURING TRANSSEPTAL PUNCTURE WHEN THE PHYSICIAN WAS TENTING THE SEPTUM, RADIOFREQUENCY ENERGY WAS APPLIED AND THE NRG TRANSSEPTAL NEEDLE INADVERTENTLY SLIPPED AND CROSSED THE SEPTUM. PREMATURE VENTRICULAR CONTRACTIONS WERE OBSERVED AND THE PHYSICIAN BROUGHT THE PROTRACK PIGTAIL WIRE IN THROUGH THE TORFLEX TRANSSEPTAL GUIDING SHEATH. THE PHYSICIAN HAD DIFFICULTY GETTING THE PROTRACK PIGTAIL WIRE TO CURL. ONCE BOTH CURLS HAD DEPLOYED ACROSS THE SEPTUM, THE PHYSICIAN BROUGHT THE TORFLEX TRANSSEPTAL GUIDING SHEATH UP. NO EFFUSION WAS NOTED AT THIS TIME. THE PROTRACK PIGTAIL WIRE WAS REMOVED AND THE CURL WAS VISUALLY OBSERVED TO STILL BE INTACT WITH NO ANOMALIES. AT THE END OF THE PROCEDURE, A LARGE EFFUSION WAS NOTED THAT RESULTED IN PERICARDIOCENTESIS WITH 400CC OF BLOOD REMOVED FROM THE HEART. THE CASE WAS NOTED TO BE CHALLENGING. THERE IS NO EVIDENCE TO SUGGEST THAT A BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS BAYLIS MEDICAL DEVICES WERE REPORTED TO BE AMONG THE DEVICES US

  Patient problems: Pericardial Effusion

  MAUDE report 8867688 ↗