CometRecalls & reported problems across all models

We found 3 models of Comet by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 139 adverse event reports in the FDA's MAUDE database, received between Feb 1, 2017 and Dec 19, 2023 — classified as 23 injuries, 116 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (45 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Comet problems

Comet models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Comet H7493932430

  TRANSDUCER, PRESSURE, CATHETER TIP
  56 reports
• Comet H7493932440

  TRANSDUCER, PRESSURE, CATHETER TIP
  50 reports
• Comet H7495551110

  TRANSDUCER, PRESSURE, CATHETER TIP
  33 reports

Recent Comet adverse event reports

The 15 most recent reports across all models, 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 THE COMET PRESSURE GUIDEWIRE WAS WITHDRAWN TO THE MIDDLE SEGMENT OF THE LAD STENT, AND RESISTANCE WAS FELT DURING WITHDRAWAL.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 ↗
• 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 ↗
• 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 ↗
• 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 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 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 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 ↗
• 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 ↗
• 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 ↗

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