Comet H7493932430Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 08714729904397), received between Oct 23, 2018 and Dec 19, 2023 — classified as 8 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (20 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 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE COMET PRESSURE GUIDEWIRE WAS USED FOR FFR DETECTION ON THE LEFT CIRCUMFLEX ARTERY (LCX) AND THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE FFR RESULT OF THE LCX WAS 0.82, AND THE FFR RESULT OF THE LAD WAS 0.71. THE LAD WAS TREATED FIRST. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED WITH THE COMET PRESSURE GUIDEWIRE WHICH WAS USED AS THE WORKING WIRE FOR THE LAD. DURING ADVANCEMENT OF THE WIRE, RESISTANCE WAS ENCOUNTERED. A BALLOON CATHETER AND CUTTING BALLOONS WERE USED TO EXPAND THE LESIONS. AFTER PTCA PRETREATMENT, A 3.0 X 36MM STENT WAS IMPLANTED, AND THE COMET PRESSURE GUIDEWIRE WAS CONNECTED TO THE HANDLE FOR A FINAL POST-LAD FFR TEST. THE COMET PRESSURE GUIDEWIRE WAS WITHDRAWN TO THE MIDDLE SEGMENT OF THE LAD STENT, AND RESISTANCE WAS FELT DURING WITHDRAWAL. THE PHYSICIAN CONTINUED TO PULL BACK, AND THE ANGIOGRAPHY SHOWED THAT THE END OF THE COME PRESSURE GUIDEWIRE FRACTURED IN THE STENT. THE BROKEN END OF THE COMET PRESSURE GUIDEWIRE WAS REMOVED BY EXTENDING THE CATHETER TOGETHER WITH THE BALLOON. THE PROCEDURE TIME WAS 90 MINUTES. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18359972 ↗
• InjurySep 27, 2023Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01SEP2023. IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE WAS STRETCHED DURING USE. A COMET II PRESSURE GUIDEWIRE WAS USED FOR CARDIAC INTERVENTION. DURING THE PROCEDURE, THE TIP OF THE GUIDEWIRE WAS STRETCHED, AND THE TIP COULD NOT BE SHAPED. AFTER REPEATED ATTEMPTS, IT STILL COULD NOT REACH THE DISTAL END OF THE BLOOD VESSEL. ANOTHER PRESSURE GUIDEWIRE WAS USED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE TIP WAS STRETCHED FOR 7MM IN LENGTH AND DETACHED AT AN UNKNOWN LOCATION. IT WAS FURTHER REPORTED THAT THE TIP OF THE DEVICE WAS STRETCHED AND THERE IS NO DETACHED PORTION. ALSO, NO FRACTURE WAS NOTED. DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17824753 ↗
• MalfunctionApr 27, 2022Failure to Zero; Failure to Zero

  REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT THE COMET PRESSURE GUIDEWIRE WAS NOT RECOGNIZED AND ZEROED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A FRACTURED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14221833 ↗
• MalfunctionMar 10, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT A PROCEDURE WAS CANCELED. A COMET DEVICE WAS ADVANCED TO PERFORM FRACTIONAL FLOW RESERVE (FFR) DIASTOLIC HYPEREMIA-FREE (DHF) ON THE ANTERIOR DESCENDING ARTERY (ADA). THERE WAS NO MEASUREMENT OF VALUES AND IT WAS NOTED THAT THERE WAS A WARNING OF A NON EXISTENT PROBLEM (PATIENT WITHOUT ANY ARRHYTHMIA). THE ATTEMPT TO PERFORM CARDIAC CATHETERIZATION WAS UNSUCCESSFUL DUE TO TECHNICAL PROBLEMS. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 11457554 ↗
• InjuryDec 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP SEPARATION, UNRETRIEVED DEVICE FRAGMENT, ADDITIONAL INTERVENTION, AND VASCULAR PERFORATION OCCURRED. A CORONAROGRAPHY WAS PERFORMED ON A LESION IN THE INTERMEDIATE STENOSED RIGHT CORONARY ARTERY (RCA). VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. A COMET WIRE WAS ADVANCED, AND WHILE NAVIGATING INTO THE 2ND SEGMENT OF THE RCA, THE RADIOPAQUE SEGMENT FRACTURED, WHICH REMAINED IN THE VESSEL. IT WAS NOTED THAT WHILE PROGRESSING IN THE RCA TO REACH THE LESION INTENDED FOR EVALUATION, THE RADIOPAQUE SEGMENT OF THE COMET WIRE WAS OBSERVED TO BE FRACTURED AND SEPARATED FROM THE WIRE. THE SEPARATION OCCURRED 3CM FROM THE TIP. A NEW ANGIOGRAPHY WAS PERFORMED AND THERE WAS AN ATTEMPT TO WITHDRAW THE FRACTURED SEGMENT DURING THE SECOND PROCEDURE BUT FAILED AND RESULTED WITH A VASCULAR PERFORATION. IT WAS NOTED THAT THE TIP OF THE GUIDE/DIAGNOSTIC CATHETER MAINTAINED POSITION IN THE OSTIUM DURING THE ENTIRE PROCEDURE. IT WAS LATER REPORTED THAT NO OTHER DEVICES WERE TRACKED OVER THE WIRE AND THAT THE COMET WIRE FRACTURED WHEN NAVIGATING DOWN THE ARTERY, THERE WAS NO ABNORMALITY IN IN THE PATIENT'S ANATOMY, AND THE TIP DID NOT BECOME TRAPPED AT ANY POINT DURING TH

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available; Perforation

  MAUDE report 11050862 ↗
• MalfunctionOct 26, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT FAILURE TO DISCONNECT A WIRE OCCURRED. A COMET PRESSURE GUIDEWIRE WAS USED DURING IN A PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR MEASUREMENT OF THE TARGET LESION. HOWEVER, AFTER MEASUREMENT, THE WIRE WAS UNABLE TO DISCONNECT FROM THE COMET DEVICE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. HOWEVER, THE DEVICE RETURNED AND ANALYSIS REVEALED THAT THE PRESSURE GUIDEWIRE WAS DETACHED/SEPARATED AT THE MID SECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10734802 ↗
• MalfunctionOct 14, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT SIGNAL ISSUES WITH A PRESSURE GUIDEWIRE OCCURRED. DURING PREPARATION AND WHILE OUTSIDE THE PATIENT, A COMET DEVICE WAS CONNECTED TO THE CONSOLE, BUT NO PRESSURE SIGNAL OCCURRED. IT WAS NOTED THAT THE GUIDEWIRE DID NOT LIGHT UP AT THE CONSOLE, AND THE LIGHT ON THE CONSOLE WAS RED. ANOTHER COMET WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO TIS EVENT. HOWEVER, THE DEVICE WAS RETURNED AND ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10676748 ↗
• MalfunctionOct 12, 2020Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17SEP2020. IT WAS REPORTED THAT A CONNECTION ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THIS COMET PRESSURE GUIDEWIRE WAS PREPPED, BUT CONNECTION ISSUES WERE NOTICED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10662182 ↗
• MalfunctionSep 28, 2020Contamination; Difficult to Open or Remove Packaging Material; Contamination; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT A COMET DROPPED ON THE FLOOR. DURING PREPARATION AND WHILE OUTSIDE THE PATIENT, A COMET PRESSURE GUIDEWIRE WAS BEING REMOVED FROM THE PACKAGING, BUT DROPPED ON THE FLOOR. IT WAS NOTED THAT THE INTERNAL PLASTIC SHEET ON THE OPPOSITE SIDE OF THE PLANNED OPENING STRAP OF THE COMET PACKAGING WAS REMOVED, BUT THE INTERLAYER SUDDENLY TORE OFF INTO TWO PARTS AND THE COMET PRESSURE GUIDEWIRE DROPPED ON THE FLOOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10596647 ↗
• MalfunctionSep 1, 2020Failure to Zero; Failure to Zero

  IT WAS REPORTED THAT FAILURE TO ZERO A PRESSURE GUIDEWIRE OCCURRED. DURING PREPARATION OF A DIASTOLIC FRACTIONAL RESERVE (DFR) AND WHILE OUTSIDE THE PATIENT, DEDICATED STEPS WERE PERFORMED TO CONNECT A COMET PRESSURE GUIDEWIRE TO AN FFR LINK, BUT THE PRESSURE GUIDEWIRE WOULD NOT ZERO. IT WAS NOTED THAT TURNING THE FFR LINK OFF AND ON AGAIN DID NOT RESOLVE THE ISSUE. THE COMET WIRE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10476860 ↗
• MalfunctionSep 1, 2020Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED 15 AUG 2020. IT WAS REPORTED THAT THE COMET PRESSURE GUIDEWIRE WAS NOT PROVIDING A PRESSURE VALUE AS INTENDED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10476300 ↗
• MalfunctionAug 31, 2020Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07AUG2020. IT WAS REPORTED THAT A SIGNAL ISSUE OCCURRED. DURING PREPARATION, CONNECTION ISSUES WITH THIS COMET PRESSURE GUIDEWIRE WERE NOTICED WHILE OUTSIDE THE PATIENT. THERE ARE NO KNOWN PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10471539 ↗
• MalfunctionAug 4, 2020Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23JUL2020. THE TARGET LESION WAS LOCATED IN THE STENOSIS DISTAL LEFT MAIN ARTERY. THIS COMET PRESSURE WIRE WAS SELECTED AND EQUALIZED SUCCESSFULLY PERFORMED IN THE AORTA. THEY WIRE WAS THEN PLACED IN THE CIRCUMFLEX ARTERY, HOWEVER, THERE WAS NO SIGNAL FROM THE COMET WIRE TO THE SCREEN. THE FFR LINK WAS TURNED OFF AND BACK ON BUT THERE WAS STILL NO SIGNAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10363700 ↗
• MalfunctionAug 3, 2020Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT DIFFICULTY ADVANCING AND TIP DAMAGE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA). A 2.0 X 15 EMERGE BALLOON WAS ADVANCED TO PREDILATE THE TARGET LESION. A COMET PRESSURE GUIDEWIRE WAS ADVANCED TO THE TARGET LESION, BUT COULD NOT PASS THROUGH THE ANGLE DUE TO A RESISTANCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10358246 ↗
• MalfunctionJul 23, 2020Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED 21 JUL 2020. IT WAS REPORTED THAT THE COMET PRESSURE GUIDEWIRE WAS NOT FUNCTIONING AS INTENDED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10314999 ↗
• MalfunctionJul 14, 2020Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23 JUN 2020. IT WAS REPORTED THAT THE WAS DIFFICULTY CROSSING THE LESION AND THE TIP BECAME DAMAGED. IT WAS REPORTED THAT THIS COMET GEN 1 PRESSURE GUIDEWIRE WAS SELECTED FOR A PERCUTANEOUS CORONARY INTERVENTION. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS VESSEL AND SEVERELY CALCIFICATION RIGHT CORONARY ARTERY. THE LESION WAS PREDILATED WITH AN EMERGE BALLOON CATHETER. WHILE ADVANCING THE COMET PRESSURE WIRE THE PHYSICIAN COULD NOT PASS THROUGH THE ANGLE DUE TO THE RESISTANCE. UPON REMOVAL TIP DAMAGE WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10271389 ↗
• MalfunctionJun 24, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT A COMET WIRE COULD NOT EQUALIZE. DURING PREPARATION AND WHILE OUTSIDE THE PATIENT, A COMET PRESSURE GUIDEWIRE COULD NOT BE EQUALIZED WITH A POLARIS CART. IT WAS NOTED THAT NO SEDATION WAS GIVEN. THE DEVICE WAS REMOVED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT AND THE PATIENT WAS REPORTED TO BE STABLE FOLLOWING THE PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10191772 ↗
• MalfunctionJun 23, 2020Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE UPON DEVICE ANALYSIS ON 09JUN2020. IT WAS REPORTED THAT THE COMET GEN 1 PRESSURE GUIDEWIRE WAS UNABLE TO BE RECOGNIZED DURING PROCEDURE. THERE IS NO KNOWN IMPACT TO THE PATIENT. THE DEVICE WAS RETURNED FOR ANALYSIS. UPON ANALYSIS, IT WAS DISCOVERED THERE WAS PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10183641 ↗
• MalfunctionJun 4, 2020Communication or Transmission Problem; Detachment of Device or Device Component; Difficult to Advance; Material Deformation; Communication or Transmission Problem; Detachment of Device or Device Component; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. A FRACTIONAL FLOW RESERVE (FFR) PROCEDURE WAS BEING PERFORMED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. THIS COMET PRESSURE GUIDEWIRE WAS SELECTED AND FFR WAS SUCCESSFULLY PERFORMED IN THE RIGHT CORONARY ARTERY. THEY ATTEMPTED TO PERFORM ANOTHER DIAGNOSIS IN THE LEFT ANTERIOR DESCENDING ARTERY; HOWEVER, THERE WAS DIFFICULTY CROSSING THE VERY NARROW AND TORTUOUS LESION. ONCE THEY WERE ABLE TO CROSS THE LESION THEY NOTICED THAT THE SIGNAL WAS LOST AND MEASUREMENTS WERE UNABLE TO BE COMPLETED. DURING WITHDRAWAL THEY NOTICED THAT A SEPARATION OCCURRED INSIDE THE SLEEVE APPROXIMATELY 3CM FROM THE DISTAL TIP. THEY MANAGED TO RETRIEVE THE COMPLETE LENGTH OF THE WIRE FROM THE PATIENT. IT WAS NOTED THAT THE DEVICE BECAME KINKED AS SOME POINT DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS IS PERFECT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10120801 ↗
• MalfunctionMar 24, 2020Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28FBE2020. IT WAS REPORTED THAT A SIGNAL COULD NOT BE DETECTED FROM A PRESSURE GUIDEWIRE. A COMET PRESSURE GUIDEWIRE WAS USED, BUT A SIGNAL COULDN'T BE DETECTED ANYMORE. IT WAS NOTED THAT THE PROBLEM OCCURRED WHILE CONNECTING TO THE FFR LINK. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE. NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9872239 ↗
• MalfunctionMar 10, 2020Fracture; Fracture

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THIS COMET PRESSURE GUIDEWIRE WAS SELECTED FOR PREPARATION; HOWEVER, WHEN REMOVING THE DEVICE FROM ITS BOX THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 9811808 ↗
• MalfunctionMar 9, 2020Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 04MAR2020. IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. WHILE A COMET PRESSURE GUIDEWIRE WAS BEING USED DURING THE PROCEDURE, THE PRESSURE SIGNAL WAS LOST. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITHOUT ISSUE OR PATIENT INJURY. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9807535 ↗
• InjuryFeb 20, 2020Communication or Transmission Problem; Detachment of Device or Device Component; Communication or Transmission Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THIS COMET PRESSURE GUIDEWIRE ALONG WITH AN ENTRY NEEDLE WERE ADVANCED TO THE TARGET LESION. HOWEVER, A TIP DETACHMENT OCCURRED. THE DETACHED TIP WAS UNABLE TO BE RETRIEVED AND WAS SECURED IN THE PATIENT CORONARY VESSEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9733975 ↗
• MalfunctionFeb 12, 2020Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 28JAN2020. IT WAS REPORTED THAT A CONNECTION ISSUE OCCURRED. DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. THIS COMET PRESSURE GUIDEWIRE WAS SELECTED; HOWEVER, THE PRESSURE WIRE FAILED TO CONNECT TO THE FFR SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9701952 ↗
• MalfunctionJan 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. IT WAS NOTED THAT THE OSTIAL LESION OF THE BRACHIO-CEPHALIC BRANCH WAS 50% STENOSED. A 6FR NON-BSC GUIDE CATHETER ALONG WITH THIS COMET PRESSURE GUIDEWIRE WERE ADVANCED. THE FIRST LESION THAT WAS EVALUATED WAS 60% STENOSED, SLIGHTLY CALCIFIED, NON-TORTUOUS,15MM IN LENGTH AND LOCATED IN THE LEFT ANTERIOR DESCENDING. THE SECOND LESION THAT WAS EVALUATED WAS A 70-90% STENOSED, CALCIFIED SHORT OSTIAL LESION LOCATED IN THE CIRCUMFLEX. THE THIRD LESION THAT WAS EVALUATED WAS 70-90% STENOSED AND LOCATED IN THE NON-TORTUOUS, CALCIFIED, 3-5MM IN LENGTH INTERMEDIATE BRANCH. WHILE ATTEMPTING TO CROSS THE THIRD LESION THEY NOTICED THAT THE DISTAL TIP OF THE COMET PRESSURE GUIDEWIRE SEPARATED INSIDE THE GUIDE CATHETER. THERE WAS NO RESISTANCE MET WHEN THE GUIDEWIRE STOP ROTATING, AND THE TIP OF THE GUIDE CATHETER MAINTAIN POSITION IN THE OSTIUM DURING THE ENTIRE PROCEDURE. THE COMET GUIDEWIRE HAD BEEN REMOVED FROM THE PATIENT FOR RESHAPING BUT DID NOT BECOME KINKED OR PROLAPSED. THE DISTAL TIP WAS REMOVED BY TRAPPING IT INSIDE THE GUIDE CA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9638861 ↗