Comet H7495551110Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 08714729875758), received between Feb 1, 2017 and Jan 26, 2021 — classified as 10 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2021Calibration Problem; Calibration Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 08JAN2021. A COMET PRESSURE GUIDEWIRE WAS BEING USED FOR A PROCEDURE IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE GUIDEWIRE WAS PREPPED IN THE USUAL FASHION AND INSERTED. THE GUIDEWIRE WOULD NOT EQUALIZE WITHIN THE ACCEPTABLE DEVIATION. THE GUIDEWIRE WAS REMOVED AND REPLACED WITH A SECOND GUIDEWIRE WHICH EQUALIZED APPROPRIATELY. NO HARM TO THE PATIENT OCCURRED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SCRAPED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11229934 ↗
• MalfunctionNov 13, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PACKAGE WAS NOT SEALED. DURING A DIAGNOSTIC LEFT HEART CATH AND WHILE OUTSIDE THE PATIENT, IT WAS NOTICED THAT A COMET PRESSURE GUIDEWIRE PACKAGE WAS NOT SEALED. THE COMET DEVICE WAS NOT USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10837794 ↗
• MalfunctionNov 13, 2020Unable to Obtain Readings

  UPPER-MIDDLE AGED FEMALE WITH HISTORY OF HYPERTENSION, DIABETES AND ACUTE ONSET OF CHEST PRESSURE. WHILE HAVING A HEART CATH, THERE WAS NO DIASTOLIC HYPEREMIA-FREE RATIO/FRACTIONAL FLOW RESERVE (DFR/FFR) READING GIVEN. POSSIBLE SOFTWARE MALFUNCTION. NO KNOWN HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10835545 ↗
• MalfunctionNov 9, 2020Unable to Obtain Readings

  ELDERLY FEMALE PRESENTED TO EMERGENCY DEPARTMENT WITH CHEST PAIN AND UNSTABLE ANGINA. WHILE HAVING A HEART CATH, ATTEMPTED WITH (2 DIFFERENT DEVICES) THE COMET WIRE TO APPREHEND DIASTOLIC HYPEREMIA-FREE RATIO/FRACTIONAL FLOW RESERVE READINGS (DFR/FFR) READING AND ALTHOUGH BOTH WIRES CROSSED LESION, NEITHER GAVE DFR/FFR. WAVEFORMS PRESENT BUT NO NUMBER READING. PLEASE NOTE THAT THERE WERE 2 PRODUCTS USED.

  Patient problems: Insufficient Information

  MAUDE report 10808643 ↗
• MalfunctionOct 7, 2020Defective Device

  ELDERLY MALE WITH HISTORY OF CORONARY ARTERY DISEASE, RECURRENT VENTRICULAR TACHYCARDIA, ATRIAL FIBRILLATION. WHILE HAVING AND OUTPATIENT HEART CATHETERIZATION, A COMET FRACTIONAL FLOW RESERVE (FFR) PRESSURE WIRE WAS INSERTED. THE WIRE FAILED TO SYNC TO THE FFR LINK. THE SUPERUSER DID TROUBLE SHOOT WITHOUT RESOLVE. A NEW COMET WIRE WAS USED WITHOUT ISSUE. NO KNOWN HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10642314 ↗
• MalfunctionSep 29, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE DEVICE WAS CONTAMINATED. A PERCUTANEOUS CORONARY INTERVENTION WAS TO BE PERFORMED. DURING UN-PACKAGING OF THE COMET PRESSURE GUIDEWIRE, IT WAS NOTICED THAT THE BOTTOM SEAL OF THE INNER PACKAGE WAS NOT SEALED AND THE WIRE SLID OUT OF THE PACKAGE. THE DEVICE WAS NOT USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITHOUT FURTHER ISSUE OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10599056 ↗
• MalfunctionSep 15, 2020Defective Device; Defective Device

  REPORTABLE BASED ON ANALYSIS COMPLETED 27 AUG 2020. IT WAS REPORTED THAT THE COMET PRESSURE GUIDEWIRE LOOKED DEFECTIVE AND WAS NOT CONNECTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10534342 ↗
• MalfunctionJun 30, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE COMET PRESSURE GUIDEWIRE FRACTURED. THE COMET GUIDEWIRE WAS SELECTED FOR A PROCEDURE TO TREAT THE LEFT ANTERIOR DESCENDING VESSEL. THE WIRE FRACTURED WHEN TRYING TO ADVANCE. THERE IS NO KNOWN HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10214585 ↗
• MalfunctionApr 29, 2020Failure to Zero; Failure to Zero

  IT WAS REPORTED THAT FAILURE TO ZERO A PRESSURE GUIDEWIRE OCCURRED. DURING PREPARATION AND OUTSIDE THE PATIENT, A COMET PRESSURE GUIDEWIRE WAS PLUGGED INTO AN FFR LINK, BUT IT DID NOT ZERO. THE FFR LINK ZERO LIGHT WAS FLASHING RED. ANOTHER COMET WIRE WAS OPENED, AND IT ZEROED. THE CASE PROCEEDED AND AN INTERVENTION WAS PERFORMED AS NEEDED. ANOTHER COMET WAS LATER USED. THE COMET HAD THE SAME ISSUE AND WAS NOT ABLE TO ZERO AFTER IT WAS PLUGGED INTO THE FFR LINK. IN ANOTHER ROOM, THE COMET WIRES WERE CONNECTED TO THE FFR LINK TO HELP DETERMINE WHETHER OR NOT THE ISSUE WAS WITH THE FFR LINK AND NOT THE COMET WIRES. THE COMET WIRES THAT WERE TESTED WERE UNABLE TO ZERO AFTER THEY WERE PLUGGED INTO THE FFR LINK. IT WAS NOTED THAT THE COMET WIRES WERE SEATED CORRECTLY IN THE FFR LINK AND THE WORKFLOWS WERE FOLLOWED CORRECTLY. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. HOWEVER, A COMET DEVICE RETURNED AND ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10010540 ↗
• MalfunctionApr 21, 2020Failure to Zero; Failure to Zero

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 26MAR2020. IT WAS REPORTED THAT COMET PRESSURE GUIDEWIRE HAD POOR SIGNAL AND COULD NOT ZERO THE WIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITHOUT ISSUE OR PATIENT INJURY. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Patient Involvement

  MAUDE report 9981572 ↗
• MalfunctionApr 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AT WIRE BREAK OCCURRED. THIS COMET PRESSURE GUIDEWIRE WAS SELECTED. DURING THE PROCEDURE THE UNSPECIFIED GUIDE CATHETER BECAME KINKED AND THEY WERE UNABLE TO TORQUE THE WIRE. WHILE REMOVING THE DEVICE THE GUIDEWIRE BROKE. THE GUIDE CATHETER AND GUIDEWIRE WERE BOTH REMOVED FROM THE PATIENT. THERE WAS NO HARM REPORT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9930605 ↗
• MalfunctionMar 2, 2020Calibration Problem; Calibration Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 07FEB2020 IT WAS REPORTED THAT A PRESSURE GUIDEWIRE WAS UNABLE TO ZERO. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A COMET PRESSURE GUIDEWIRE WAS ADVANCED TO THE TARGET LESION, BUT WAS UNABLE TO ZERO. THIS OCCURRED WHILE ATTEMPTING TO EQUALIZE. IT WAS NOTED THAT THE PRESSURE GUIDEWIRE WAS INITIALLY ZEROED OUTSIDE OF THE PATIENT, BUT WOULD NOT EQUALIZE. THE PROCEDURE WAS COMPLETED WITHOUT USING THE DEVICE OR EXCHANGING THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT AND THE PATIENT WAS REPORTED TO BE FINE. HOWEVER, DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9775918 ↗
• MalfunctionFeb 27, 2020Calibration Problem; Calibration Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED 7 FEB 2020. IT WAS REPORTED THAT AN EQUALIZING ISSUE OCCURRED. IT WAS REPORTED THAT THE COMET PRESSURE GUIDEWIRE WOULD NOT EQUALIZE. 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 9765211 ↗
• InjuryFeb 5, 2020Output Problem; Output Problem

  IT WAS REPORTED THAT CHEST PAIN AND ST SEGMENT CHANGES OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED ON A PREVIOUSLY KNOWN LEFT ANTERIOR DESCENDING STENT AND 100% OCCLUDED CIRCUMFLEX ARTERY. AN ANGIOGRAM OF THE RIGHT CORONARY ARTERY SHOWED AN INTERMEDIATE MID LESION AND DFR WAS PERFORMED TO DETERMINE SIGNIFICANCE. AFTER EQUALIZATION, THE DFR VALUE DISTAL TO THE LESION READ 0.81. THE COMET WIRE WAS DISCONNECTED AND A 3.0X24MM DRUG ELUDING STENT WAS DIRECTLY IMPLANTED OVER THE COMET WIRE TO THE LESION. A SLIGHTLY HAZY REGION WAS NOTED DISTAL TO THE STENT AND ANOTHER 3.0X8MM DRUG ELUDING STENT WAS IMPLANTED ON THE DISTAL OVERLAP OF THE FIRST STENT TO COVER THE HAZY REGION. THE PATIENT STARTED TO EXPERIENCE SOME CHEST PAIN AND ST SEGMENT CHANGES AT THIS POINT. THE COMET WIRE WAS RECONNECTED AND ANOTHER DFR MEASUREMENT WAS MADE RESULTING IN 0.80. NO FURTHER INTERVENTION WAS PERFORMED AND THE PATIENT WAS STABILIZED AND NO LONGER COMPLAINING OF CHEST PAIN WHEN HE LEFT THE ROOM.

  Patient problems: Chest Pain; ST Segment Elevation

  MAUDE report 9672855 ↗
• InjuryFeb 5, 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 FUNCTIONAL FLOW RESERVED (FFR) PROCEDURE WAS BEING PERFORMED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND NON CALCIFIED OBTUSE MARGINAL (OM) OFF OF THE CIRCUMFIX. THERE WERE NO PREVIOUS DEVICES INSIDE OF THE OM. THIS 185CM COMET PRESSURE GUIDEWIRE WAS ADVANCED TO THE LESION, THEY STARTED PERFORMING FFR MEASUREMENTS, BUT THEY WERE UNABLE TO GET A PRESSURE READING. FLUOROSCOPY WAS USED TO SEE WHAT MAY HAVE BEEN CAUSING THE ISSUE, AT THIS TIME THE PHYSICIAN NOTICED THAT THE RADIOPAQUE TIP HAD SEPARATED FROM THE BODY OF THE GUIDEWIRE. THEY TRIED TO PULLBACK ON THE GUIDEWIRE HOPING THAT THERE WAS A SMALL THREAD STILL CONNECTING THE TWO PIECES, BUT THEY HAD COMPLETELY SEPARATED. THEY PROCEEDED TO USE WIRES AND BALLOONS TO PULL THE GUIDEWIRE TIP BACK AND ULTIMATELY, THEY NEEDED TO USE A SNARE TO REMOVE THE DETACHED TIP. THE DETACHED GUIDEWIRE TIP WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO ADVERSE EVENTS TO THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 9672487 ↗
• MalfunctionDec 17, 2019Failure to Zero; Failure to Zero

  REPORTABLE BASED ON THE PRODUCT ANALYSIS COMPLETED ON NOVEMBER 21, 2019. IT WAS REPORTED THE PRESSURE WIRE WOULD NOT ZERO. A 185CM COMET PRESSURE GUIDEWIRE WAS SELECTED FOR USE IN A FRACTIONAL FLOW RESERVE (FFR) PROCEDURE. DURING PREPARATION FOR THE PROCEDURE, OUTSIDE OF THE PATIENT, THE WIRE WOULD NOT ZERO. THE WIRE WAS UNPLUGGED AND PLUGGED BACK IN A COUPLE OF TIMES BUT WAS STILL UNABLE TO ZERO. THE CASE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE WITH NO COMPLICATIONS. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9482068 ↗
• MalfunctionNov 27, 2019Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED A PRESSURE SIGNAL ISSUE OCCURRED. DURING PREPARATION OF AN FFR PROCEDURE AND OUTSIDE THE PATIENT, A COMET PRESSURE GUIDEWIRE WAS USED AND WAS NOT ABLE TO CONNECT TO THE FFR LINK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED PEELED COATING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9385425 ↗
• MalfunctionNov 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A WIRE BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 70% STENOSED LESION WAS LOCATED IN THE NON TORTUOUS AND CALCIFIED, 20MM TARGET LESION. THIS 185CM COMET PRESSURE GUIDEWIRE WAS SELECTED ALONG WITH A OPTICROSS 6 IMAGING CATHETER WHICH WAS LOADED ONTO THE COMET WIRE AND WERE DELIVERED BEYOND THE LESION. AFTER IMAGING WAS PERFORMED AND THE OPTICROSS IMAGING CATHETER WAS WITHDRAWN AND THE PHYSICIAN FELT A "SNAP". ANGIOGRAM REVEALED THAT THE COMET WIRE HAD SEPARATED INTO TWO PIECES IN THE PROXIMAL SEGMENT OF THE RADIOPAQUE TIP. THE PHYSICIAN RETRACTED THE COMET WIRE AND IMAGING CATHETER INTO THE GUIDE CATHETER AS ONE UNIT. ALL PARTS OF THE WIRE WERE RETRIEVED FROM THE BODY. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9375731 ↗
• MalfunctionOct 29, 2019Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT LOW SIGNALS WHILE USING A PRESSURE GUIDEWIRE OCCURRED. DURING AN FFR PROCEDURE, OUTSIDE THE PATIENT BODY, A 185 CM COMET PRESSURE GUIDEWIRE WAS USED. LOW SIGNALS OCCURRED WHILE USING THE COMET WIRE. 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 9250543 ↗
• InjuryOct 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORT THAT A WIRE BREAK OCCURRED. DURING A LEFT HEART CATHETERIZATION PROCEDURE, VASCULAR ACCESS WAS OBTAINED VIA RIGHT RADIAL ARTERY. ANGIOGRAPHY WAS BEING PERFORMED WHEN THEY NOTICED A 40% STENOSED, 5MM IN LENGTH, NON TORTUOUS, AND MODERATELY CALCIFIED FIBROTIC LESION LOCATED INSIDE THE STENT OF THE MID-LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LAD WAS THE ONLY VESSEL THAT THEY TOOK FRACTIONAL FLOW RESERVE (FFR) MEASUREMENTS IN. A COMET PRESSURE GUIDEWIRE WAS SELECTED AND INSERTED THROUGH A NON-BSC 5F JL4 DIAGNOSTIC CATHETER. DURING ADVANCEMENT THE DEVICES TOOK A TURN INTO THE 1ST DIAGONAL BRANCH. THEY DEVICES WERE PULLED BACK A COUPLE OF TIMES TO BE REDIRECTED, BUT THEY WERE NO LONGER TORQUEING. AFTER NOTICING THAT, THEY PULLED THE COMET GUIDEWIRE BACK AND THEY NOTICED THAT THE DISTAL RADIOPAQUE PORTION OF THE TIP DETACHED FROM THE TRANSDUCER AND WAS LEFT IN THE PROXIMAL LAD/1ST DIAGONAL. THE COMET GUIDEWIRE WAS NEVER KINKED OR PROLAPSED. THROUGHOUT THE PROCEDURE POSITION WAS MAINTAINED WITH BOTH THE COMET GUIDEWIRE AND GUIDE CATHETER. THE NON-BSC 5F JL4 DIAGNOSTIC CATHETER WAS REPLACED WITH A NON-BSC 6F JL4 GUIDE CATHETER ALONG WITH A 4MM NON-BSC MICRO-SNARE TO RETRIEV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9197546 ↗
• InjuryOct 8, 2019Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT A GUIDEWIRE DETACHMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. THE COMET PRESSURE GUIDEWIRE WAS PREPPED AND WAS INSERTED THROUGH A NON-BSC DIAGNOSTIC CATHETER. DURING ADVANCEMENT INTO THE RIGHT CORONARY ARTERY(RCA), AN ANGIOGRAM REVEALED THAT THE TIP OF THE COMET WIRE PROLAPSED WHILE IN THE 2-2.5MM IN DIAMETER DISTAL POSTERIOR LEFT VENTRICULAR WALL. FRACTIONAL FLOW RESERVE (FFR) MEASUREMENTS WERE SUCCESSFULLY TAKEN OF THE RCA. THE COMET PRESSURE WIRE AND DIAGNOSTIC CATHETER WERE REMOVED. A DECISION WAS THEN MADE TO FFR THE LEFT CIRCUMFLEX ARTERY. PRIOR TO RE-INSERTION THEY FOUND THAT THE COMET WIRE WAS BENT. USING AN INTRODUCER TOOL THE COMET WIRE WAS STRAIGHTENED OUT AND RESHAPED. THE COMET WIRE, ALONG WITH A 3.5 FR NON-BSC GUIDE CATHETER WERE THEN RE-INSERTED INTO THE 50% STENOSED,NON-TORTUOUS AND NON-CALCIFIED,10MM IN LENGTH LEFT CIRCUMFLEX ARTERY. WHILE ADVANCING THE COMET WIRE 3-4MM INTO THE LAD, THE WIRE PROLAPSED AT THE SENSOR. WHILE PULLING BACK THE COMET WIRE THE SENSOR HIT THE 3.5 FR NON-BSC GUIDE CATHETER AND A TIP SEPARATION OCCURRED. A SNARE WAS USED TO SUCCESSFULLY REMOVE THE WIRE TIP. ALL PARTS OF THE DEVICE WERE REMOV

  Patient problems: No Code Available

  MAUDE report 9168313 ↗
• InjuryJun 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT A COMET GUIDE WIRE FRACTURED OCCURRED. THE TARGET LESION WAS LOCATED IN THE 60% STENOSED, TORTUOUS, AND CALCIFIED LEFT CIRCUMFLEX ARTERY (LCX). THIS 185CM COMET PRESSURE GUIDEWIRE ALONG WITH A 3.5MM NON-BSC GUIDE CATHETER WERE ADVANCED TO FIRST EVALUATE THE LEFT ANTERIOR DESCENDING ARTERY. THEN THE COMET PRESSURE GUIDEWIRE WAS ADVANCED INTO THE LCX, WHERE FRACTIONAL FLOW RESERVE (FFR) WAS COMPLETED. DURING REMOVAL THERE WAS MINOR PROLAPSE OF THE COMET PRESSURE GUIDEWIRE AND TIP BECAME WEDGED IN THE CALCIFIED PLAQUE. THREE CM OF THE COMET PRESSURE GUIDEWIRE TIP BECAME DETACHED. SEVERAL ATTEMPTS WERE MADE TO SNARE THE COMET PRESSURE GUIDEWIRE TIP, BUT DECIDED TO LEAVE THE DETACHED TIP SINCE THE PATIENT WAS SCHEDULE FOR BYPASS SURGERY THE FOLLOWING DAY. DURING THE BYPASS SURGERY THE COMET GUIDEWIRE TIP WAS SUCCESSFULLY REMOVED.

  Patient problems: No Code Available

  MAUDE report 8707890 ↗
• MalfunctionMay 14, 2019Fracture

  FFR WIRE FRACTURED WITH PART OF THE WIRE REMAINING IN LCX. UNSUCCESSFUL ATTEMPTS WERE MADE TO REMOVE THE FRACTURED PIECE OF THE WIRE. THE PATIENT WAS SCHEDULED FOR A BYPASS SURGERY THE NEXT DAY IN WHICH THE PIECE WAS REMOVED. MANUFACTURER RESPONSE FOR TRANSDUCER, PRESSURE, CATHETER TIP, COMET (PER SITE REPORTER). THE FIELD REPRESENTATIVE WAS NOTIFIED OF THE ISSUE BY THE PHYSICIAN. NO FEEDBACK HAS BEEN RECEIVED AT THIS TIME. FURTHER CORRESPONDENCE WILL BE SHARED AS IT BECOMES AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 8607978 ↗
• MalfunctionApr 15, 2019Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT THE 185CM COMET PRESSURE GUIDEWIRE WOULD NOT ZERO. THIS OCCURRED PRIOR TO ADVANCING THE DEVICE INTO THE PATIENT AND THE DEVICE WAS UNABLE TO BE USED. THE PROCEDURE WAS COMPLETED BY OPENING ANOTHER COMET WIRE AND THE CASE WAS COMPLETED. THE PATIENT IS DOING WELL WITH NO COMPLICATIONS. HOWEVER, THE RETURNED DEVICE ANALYSIS REVEALED SOME PEELING OF THE DEVICE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8514600 ↗
• MalfunctionApr 8, 2019Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED 03 APRIL 2019. IT WAS REPORTED THAT THE185CM COMET PRESSURE GUIDEWIRE WOULD NOT ZERO. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT ISSUES. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SOME SLIGHT PEELING OF THE DEVICE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8492823 ↗