Comet H7493932440Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 08714729904403), received between Feb 16, 2017 and Oct 28, 2020 — classified as 5 injuries, 45 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. 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 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT SIGNAL ISSUES OCCURRED. DURING INSERTION OF A COMET PRESSURE GUIDEWIRE, A LOSS OF SIGNAL OCCURRED. IT WAS NOTED THAT NO PRESSURE WAS DISPLAYED DURING INSERTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. HOWEVER, DEVICE RETURNED AND DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10750561 ↗
• MalfunctionOct 22, 2020Output Problem; Output Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01OCT2020. IT WAS REPORTED THAT A PRESSURE DRIFT ISSUE OCCURRED. THIS COMET PRESSURE WIRE WAS INSIDE THE PATIENT WHEN ISSUES WERE NOTICED WITH THE PRESSURE DRIFTING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT INJURY. HOWEVER, DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10722131 ↗
• MalfunctionSep 21, 2020Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED 4 SEPT 2020. IT WAS REPORTED THAT A DRIFT IN PRESSURE VALUE OCCURRED WITH THE COMET PRESSURE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, UPON RECEIVING THE DEVICE, PEELING OF THE COATING WAS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10559913 ↗
• MalfunctionSep 2, 2020Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT WIRE KINK AND DIFFICULTY ADVANCING OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON CALCIFIED MID RIGHT CORONARY ARTERY. THIS COMET PRESSURE GUIDEWIRE WAS SELECTED BUT THERE WAS DIFFICULTY MANIPULATING THE WIRE DURING INSERTION DUE TO THE TORTUOSITY OF THE VESSEL AND THE SHAFT AT THE HAND BASE BECAME KINKED. THE WIRE WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. HOWEVER, DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10485192 ↗
• MalfunctionSep 1, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT WIRE KINK OCCURRED. WHEN THE COMET PRESSURE GUIDEWIRE WAS INSERTED INTO THE PATIENT, THE WIRE KINKED AT THE BASE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT INJURY. HOWEVER, DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10476472 ↗
• MalfunctionAug 31, 2020Material Deformation; Material Deformation

  REPORTABLE BASED ON ANALYSIS COMPLETED 11 AUG 2020. IT WAS REPORTED THAT THE COMET PRESSURE GUIDEWIRE WAS KINKED DURING USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10473043 ↗
• MalfunctionAug 26, 2020Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05AUG2020. IT WAS REPORTED THAT A DRIFT ISSUE OCCURRED. THIS COMET PRESSURE WIRE HAD ISSUES EQUALIZING WHILE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10457376 ↗
• MalfunctionAug 5, 2020Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16JUL2020. IT WAS REPORTED THAT A CONNECTION ISSUE OCCURRED. THE TARGET LESION LOCATED IN THE MILDLY STENOSED AND MILDLY CALCIFIED LESION. THIS COMET PRESSURE WIRE WAS SELECTED, DURING PREPARATION A CONNECTION ISSUES WERE NOTICED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10368924 ↗
• MalfunctionJul 15, 2020Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED 24 JUN 2020. IT WAS REPORTED THAT THE COMET PRESSURE GUIDEWIRE ENCOUNTERED A DRIFT IN PRESSURE VALUES. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10279616 ↗
• InjuryJul 14, 2020Failure to Advance; Communication or Transmission Problem; Detachment of Device or Device Component; Failure to Advance; 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 A FEMORAL APPROACH. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED DISTAL RIGHT CORONARY ARTERY. A NON BSC GUIDE CATHETER AND THIS COMET PRESSURE GUIDEWIRE WERE SELECTED. DURING ADVANCEMENT TORQUE WAS APPLIED AT THE TORTUOUS PORTION OF THE LESION, THE DEVICE WAS ABLE TO ADVANCE BUT WAS NOT UNABLE TO CROSS THE LESION. THEY ATTEMPTED TO REMOVE AND INSERT THE DEVICE SEVERAL TIMES, BUT THEY WERE STILL UNABLE TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED AGAIN, IT WAS NOTICED THAT THE OPAQUE TIP DID NOT MOVE THE SAME AND THE PD VALUE HAD DISAPPEARED ON THE POLARIS SYSTEM. AT THIS TIME, THEY FOUND THAT A SEPARATION OCCURRED NEAR THE PRESSURE SENSOR AND LASER CUT PORTION. NEGATIVE PRESSURE WAS APPLIED TO THE GUIDE CATHETER WITH A SYRINGE, AND THE SEPARATED PART WAS ABLE TO BE PULLED BACK INTO THE GUIDE CATHETER. A 1.75 NON-BSC BALLOON CATHETER WAS THEN USED TO TRAP AND REMOVE THE SEPARATED TIP. NO PATIENT COMPLICATIONS WERE REPORTED; HOWEVER, DUE TO THE AMOUNT OF EXPOSURE AND PROLONGED PROCEDURE TIME THE P

  Patient problems: No Code Available

  MAUDE report 10271806 ↗
• MalfunctionJul 7, 2020Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED 11 JUN 2020. IT WAS REPORTED THAT THE COMET PRESSURE GUIDEWIRE WAS NOT PROVIDING A PRESSURE VALUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10239701 ↗
• MalfunctionJun 23, 2020Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COMET GEN 1 PRESSURE GUIDEWIRE WAS DIFFICULT TO REMOVE. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY TO MID LAD. THIS COMET GEN 1 PRESSURE GUIDEWIRE WAS SELECTED FOR USE DURING THIS CORONARY ANGIOGRAPHY PROCEDURE. THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT INTO THE CORONARY ARTERY, HOWEVER DURING REMOVAL ABNORMAL RESISTANCE WAS FELT. A VISUAL CHECK WAS PERFORMED OUTSIDE THE BODY AND THERE WERE NO KINKS FOUND. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT INJURY DUE TO DIFFICULTY REMOVING THE GUIDEWIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10185167 ↗
• MalfunctionJun 9, 2020Failure to Advance; Failure to Advance

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 12MAY2020. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED ON A 90% STENOSED, MODERATELY CALCIFIED AND MODERATELY TORTUOUS LESION. THE COMET PRESSURE GUIDEWIRE WAS ADVANCED BUT COULD NOT CROSS THE LESION. 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 10133256 ↗
• MalfunctionMay 22, 2020Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED 12 MAY 2020. IT WAS REPORTED THAT THE COMET PRESSURE GUIDEWIRE DID NOT PROVIDE A PRESSURE VALUE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10083500 ↗
• MalfunctionMay 22, 2020Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED 7 MAY 2020. IT WAS REPORTED THAT THE COMET PRESSURE GUIDEWIRE HAD ENCOUNTERED A DRIFT IN PRESSURE VALUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10083314 ↗
• MalfunctionMay 19, 2020Failure to Zero; Failure to Zero

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 23APR2020. IT WAS REPORTED THAT THE COMET WIRE WAS NOT ABLE TO ZERO. THIS OCCURRED OUTSIDE THE PATIENT AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE OR PATIENT INJURY. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10072475 ↗
• MalfunctionMay 11, 2020Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED 30 APRIL 2020. IT WAS REPORTED THAT A CONNECTION ISSUE OCCURRED. IT WAS REPORTED THAT THE COMET PRESSURE GUIDEWIRE WOULD NOT RESPOND WHEN CONNECTED TO THE FFR LINK. THE PROCEDURE WAS COMPLETE WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10043280 ↗
• MalfunctionMay 7, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DIFFICULTY CROSSING A LESION OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS ATRIOVENTRICULAR BRANCH. A COMET PRESSURE GUIDEWIRE WAS ADVANCED BUT WAS UNABLE TO CROSS THE LESION. THEREFORE, THE FFR MEASUREMENT WAS STOPPED. IT WAS NOTED THAT THE TREATMENT WILL BE PERFORMED AT A LATER DATE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. HOWEVER, DEVICE RETURNED AND ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10033627 ↗
• MalfunctionApr 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A GUIDEWIRE BREAK OCCURRED. DURING PREPARATION, OUTSIDE THE PATIENT, AND WHILE REMOVING A COMET PRESSURE GUIDEWIRE FROM THE FREE SPIN HANDLE, IT WAS NOTICED THAT THE WIRE HAD BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. IT WAS FURTHER REPORTED THAT WHILE DISCONNECTING THE WIRE FROM THE OCC HANDLE, THE CAP PART OF THE OCC HANDLE BECAME DETACHED. THE HANDLE WAS REMOVED TOGETHER WITH THE WIRE. AFTER DISCONNECTING THE WIRE FROM THE HANDLE, THE WIRE WAS NOT ABLE TO RECONNECT TO THE HANDLE. NO DAMAGE WAS NOTED IN THE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10013265 ↗
• InjuryApr 16, 2020Entrapment of Device; Difficult to Remove; Material Integrity Problem; Entrapment of Device; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE HAD BEEN TRAPPED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. WHEN DIAGNOSTIC WAS PERFORMED USING THE COMET PRESSURE GUIDEWIRE IN THE 90% STENOSED, MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA) DISTAL TO THE ATRIOVENTRICULAR BRANCH, SPASM OCCURRED AT THE LESION AREA. AND IT SEEMED THAT THE COMET WAS TRAPPED, THEREFORE NITRO WAS ADMINISTERED AND IT WAS PULLED OUT. AS IT WAS BEING PULLED OUT, THE TIP WAS STRETCHED, SO IT WAS REPLACED WITH ANOTHER COMET. THAT DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9967574 ↗
• MalfunctionApr 16, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE DEVICE COATING. DURING PREPARATION OF A PROCEDURE, THERE WAS AN OBJECT WHICH APPEARED TO BE PEELING OF THE POLYMER COATING OF THE COMET PRESSURE GUIDEWIRE. AFTER WIPING THE DEVICE, IT WAS REMOVED, BUT THE PASSABILITY WAS NOTED TO HAVE BECOME WORSE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9967033 ↗
• MalfunctionApr 15, 2020Material Deformation; Material Deformation

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 24MAR2020. A COMET PRESSURE GUIDEWIRE WAS BEING USED AND WAS REPORTED TO HAVE KINKED. 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 9962577 ↗
• MalfunctionMar 11, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A COATING ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A COMET PRESSURE GUIDEWIRE WAS ADVANCED AND A NORMAL FFR WAS PERFORMED IN THE LAD AND THE DEVICE WAS REMOVED. WHILE ADVANCING INTO THE RIGHT CORONARY ARTERY (RCA), A BLACK DAMAGED PART WAS NOTICED TO BE ADHERED TO THE PHYSICIANS GLOVES. IT WAS NOTED THAT THE BLACK MATERIAL WAS LIKELY THE COMET COATING. IT WAS ADDITIONALLY NOTED THAT IT WAS POSSIBLE THAT THE INTERACTION WITH AN INSERTER CONTRIBUTED TO THE ISSUE, BUT THE EXACT CAUSE WAS UNKNOWN. THE BLACK MATERIAL DID NOT ENTER THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT AND THE PATIENT CONDITION WAS GOOD FOLLOWING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9819476 ↗
• MalfunctionMar 10, 2020Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 26FEB2020. DURING PREPARATION OF A COMET PRESSURE GUIDEWIRE, THE LOSS OF THE WAVEFORM (VALUE/WAVEFORM NOT DISPLAYED) OCCURRED. 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 9811721 ↗
• MalfunctionMar 4, 2020Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED 14 FEB 2020. IT WAS REPORTED THAT THE COMET PRESSURE GUIDEWIRE WAS BENT. THIS COMET PRESSURE GUIDEWIRE WAS SELECTED HOWEVER, A 3CM PORTION OF THE TIP BECOME BENT. THEY TRIED TO RESHAPE THE TIP, BUT THEY COULD NOT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9786496 ↗