HI-TORQUE WHISPER 1011834HRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 08717648116100), received between Jun 2, 2017 and Aug 28, 2026 — classified as 1 death, 13 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (19 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2026Material Separation

  It was reported that the procedure performed was a pulmonary valve perforation followed by pulmonary valvuloplasty. The 014 HT Whisper guide wire was positioned in the distal branch of the pulmonary artery. The guide wire was rotated clockwise to achieve and maintain stability. The guide wire was subsequently untwisted by counterclockwise rotation for removal. During advancement of the microcatheter over the guide wire, the guide wire tip detached and was retained within a distal branch of the right pulmonary artery. No additional information was provided.

  Patient problems: Foreign Body In Patient

  MAUDE report 50502968 ↗
• MalfunctionFeb 27, 2026Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION IN THE RIGHT CORONARY ARTERY (RCA) AND HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN IMPELLA HEART PUMP WAS PLACED ALONG WITH A TEMPORARY VENOUS PACEMAKER. AN EBU 3.5 GUIDE CATHETER WAS INSERTED INTO THE LEFT MAIN (LM) ARTERY AND THEN A NON-ABBOTT BLACK WIRE WAS INSERTED INTO THE PROXIMAL LAD. A TURNPIKE WAS INSERTED OVER THE BLACK WIRE TRYING TO CROSS THE RIGHT LESION IN THE MID LAD. THE WIRE WAS EXCHANGED FOR AN EXTRA SUPPORT WHISPER WIRE HOWEVER IT FAILED TO CROSS THE LESION AND WAS REMOVED. A SECOND WHISPER GUIDE WIRE WAS INSERTED HOWEVER FAILED TO CROSS THE LESION AND WAS REMOVED. WHEN TAKING AN ANGIOGRAM A PERFORATION WAS NOTED. PER THE PHYSICIAN, THE SECOND WHISPER GUIDE WIRE WAS TOO AGGRESSIVE FOR THE LESION; RESULTING IN THE PERFORATION. THE DECISION WAS MADE TO WATCH THE PATIENT WHO WAS HEMODYNAMICALLY STABLE. THE PROCEDURE WAS ABORTED TO LET THE PERFORATION HEAL. PATIENT THEN HAD TO HAVE A PERICARDIOCENTESIS TO REMOVE FLUID FROM THE PERICARDIUM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469004 ↗
• InjuryFeb 27, 2026Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION IN THE RIGHT CORONARY ARTERY (RCA) AND HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN IMPELLA HEART PUMP WAS PLACED ALONG WITH A TEMPORARY VENOUS PACEMAKER. AN EBU 3.5 GUIDE CATHETER WAS INSERTED INTO THE LEFT MAIN (LM) ARTERY AND THEN A NON-ABBOTT BLACK WIRE WAS INSERTED INTO THE PROXIMAL LAD. A TURNPIKE WAS INSERTED OVER THE BLACK WIRE TRYING TO CROSS THE RIGHT LESION IN THE MID LAD. THE WIRE WAS EXCHANGED FOR AN EXTRA SUPPORT WHISPER WIRE HOWEVER IT FAILED TO CROSS THE LESION AND WAS REMOVED. A SECOND WHISPER GUIDE WIRE WAS INSERTED HOWEVER FAILED TO CROSS THE LESION AND WAS REMOVED. WHEN TAKING AN ANGIOGRAM A PERFORATION WAS NOTED. PER THE PHYSICIAN, THE SECOND WHISPER GUIDE WIRE WAS TOO AGGRESSIVE FOR THE LESION; RESULTING IN THE PERFORATION. THE DECISION WAS MADE TO WATCH THE PATIENT WHO WAS HEMODYNAMICALLY STABLE. THE PROCEDURE WAS ABORTED TO LET THE PERFORATION HEAL. PATIENT THEN HAD TO HAVE A PERICARDIOCENTESIS TO REMOVE FLUID FROM THE PERICARDIUM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 24468962 ↗
• MalfunctionMay 8, 2025Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. A NC TREK BALLOON DILATATION CATHETER (BDC), AN UNSPECIFIED DRUG ELUTING STENT (DES) AND AN UNSPECIFIED IMAGING CATHETER WERE ATTEMPTED TO BE ADVANCED ON A WHISPER GUIDE WIRE (GW); HOWEVER, THE GW WAS NOT ABLE TO TRACK THE BDC AS THE WIRE FELT TOO STICKY. THE COATING THE WIRE CORE WAS PEELING DURING REMOVAL OF THE GW. DESPITE THIS, THE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21988166 ↗
• MalfunctionMay 5, 2025Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE WHISPER GUIDE WIRE WAS ATTEMPTING TO ADVANCE AN NC TREK BALLOON DILATATION CATHETER (BDC) AND A DRUG ELUTING STENT; HOWEVER, THERE WAS RESISTANCE DURING ADVANCEMENT OVER THE GUIDE WIRE. THE WIRE IS NOTED TO BE STICKY AND THE COATING OF THE TIP OF THE WIRE WAS PEELING UPON REMOVAL OF THE WIRE. A NON-ABBOTT WIRE WAS USED TO COMPLETE THE PROCEDURE WITH THE SAME NC TREK BALLOON. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962812 ↗
• MalfunctionApr 28, 2025Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 3.5 X 12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE ADVANCED ON A WHISPER GUIDE WIRE (GW); HOWEVER, THE GW WAS NOT ABLE TO TRACK THE BDC AS THE WIRE FELT TOO STICKY. THE COATING OF THE WIRE CORE WAS PEELING DURING REMOVAL OF THE GW. ANOTHER WHISPER GW WAS ATTEMPTED; HOWEVER, THE SAME ISSUE OCCURRED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922342 ↗
• MalfunctionApr 28, 2025Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 3.5 X 12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE ADVANCED ON A WHISPER GUIDE WIRE (GW); HOWEVER, THE GW WAS NOT ABLE TO TRACK THE BDC AS THE WIRE FELT TOO STICKY. THE COATING OF THE WIRE CORE WAS PEELING DURING REMOVAL OF THE GW. ANOTHER WHISPER GW WAS ATTEMPTED; HOWEVER, THE SAME ISSUE OCCURRED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922096 ↗
• MalfunctionApr 28, 2025Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 2.5 X 12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE ADVANCED ON A WHISPER GUIDE WIRE (GW); HOWEVER, THE GW WAS NOT ABLE TO TRACK THE BDC AS THE WIRE FELT TOO STICKY. THE COATING OF THE WIRE CORE WAS PEELING DURING REMOVAL OF THE GW. ANOTHER WHISPER GW WAS ATTEMPTED; HOWEVER, THE SAME ISSUE OCCURRED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921764 ↗
• MalfunctionApr 25, 2025Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 2.5X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE ADVANCED ON A WHISPER GUIDE WIRE BUT THEY WERE NOT ABLE TO TRACK IT AS THE WIRE FELT TOO STICKY. THE COATING OF THE CORE OF THE WIRE WAS PEELING WHEN THE WIRE WAS REMOVED. ANOTHER WHISPER WIRE WAS ATTEMPTED BUT HAD THE SAME ISSUES. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909793 ↗
• MalfunctionApr 24, 2025Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 3.0X15 MM NC TREK TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE ADVANCED ON A WHISPER GUIDE WIRE BUT THEY WERE NOT ABLE TO TRACK IT AS THE WIRE FELT TOO STICKY. THE COATING OF THE CORE OF THE WIRE WAS PEELING WHEN THE WIRE WAS REMOVED. ANOTHER WHISPER WIRE WAS ATTEMPTED BUT HAD THE SAME ISSUES. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21904640 ↗
• MalfunctionApr 24, 2025Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 3.0X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE ADVANCED ON A WHISPER GUIDE WIRE BUT THEY WERE NOT ABLE TO TRACK IT AS THE WIRE FELT TOO STICKY. THE COATING OF THE CORE OF THE WIRE WAS PEELING WHEN THE WIRE WAS REMOVED. ANOTHER WHISPER WIRE WAS ATTEMPTED BUT HAD THE SAME ISSUES. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903980 ↗
• MalfunctionApr 22, 2025Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER A 3CM .014 HT WHISPER GUIDEWIRE (GW) WAS ADVANCED TO THE LESION, A 3.0X12MM NC TREK BALLOON DILATATION CATHETER(BDC) WAS ATTEMPTED TO BE ADVANCED OVER THE GW; HOWEVER, THE GW WAS NOTED TO BE STICKY [RESISTANCE DURING ADVANCEMENT] AND SUBSEQUENTLY THE COATING WAS NOTED TO BE PEELED. THE GW WAS REPLACED WITH A NEW .014 WHISPER GW, BUT THE SAME ISSUE PERSISTED. THEREFORE, THE WHISPER GW WAS REPLACED WITH A NON-ABBOTT GW AND THE SAME BDC WAS TRAVERSED OVER THE NEW GW SUCCESSFULLY, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884056 ↗
• MalfunctionApr 22, 2025Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER A 3CM .014 HT WHISPER GUIDEWIRE (GW) WAS ADVANCED TO THE LESION, A 3.0X12MM NC TREK BALLOON DILATATION CATHETER(BDC) WAS ATTEMPTED TO BE ADVANCED OVER THE GW; HOWEVER, THE GW WAS NOTED TO BE STICKY [RESISTANCE DURING ADVANCEMENT] AND SUBSEQUENTLY THE COATING WAS NOTED TO BE PEELED. THE GW WAS REPLACED WITH A NEW .014 WHISPER GW, BUT THE SAME ISSUE PERSISTED. THEREFORE, THE WHISPER GW WAS REPLACED WITH A NON-ABBOTT GW AND THE SAME BDC WAS TRAVERSED OVER THE NEW GW SUCCESSFULLY, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WEAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883830 ↗
• MalfunctionFeb 13, 2025Product Quality Problem; Difficult to Remove; Difficult to Advance; Product Quality Problem; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MILDLY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. WHEN A 2.0X12MM NC TREK BALLOON WAS TRAVERSED OVER THE 0.014 WHISPER EXTRA SUPPORT (ES) GUIDE WIRE, RESISTANCE WAS FELT DURING ADVANCEMENT AND REMOVAL. THE GUIDE WIRE WAS NOTED TO FEEL TOO STICKY. ANOTHER WHISPER ES GUIDE WIRE WAS ATTEMPTED TO BE USED; HOWEVER, THE SAME ISSUE OCCURRED. A NON-ABBOTT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376053 ↗
• MalfunctionFeb 13, 2025Product Quality Problem; Difficult to Remove; Difficult to Advance; Product Quality Problem; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MILDLY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. WHEN A 2.0X12MM NC TREK BALLOON WAS TRAVERSED OVER THE 0.014 WHISPER EXTRA SUPPORT (ES) GUIDE WIRE, RESISTANCE WAS FELT DURING ADVANCEMENT AND REMOVAL. THE GUIDE WIRE WAS NOTED TO FEEL TOO STICKY. ANOTHER WHISPER ES GUIDE WIRE WAS ATTEMPTED TO BE USED; HOWEVER, THE SAME ISSUE OCCURRED. A NON-ABBOTT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376051 ↗
• InjuryJan 5, 2024Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY WITH MILD CALCIFICATION. THE HT WHISPER ES GUIDE WIRE (GW) WAS USED IN THE PROCEDURE; HOWEVER, AN UNSPECIFIED BALLOON BECAME STUCK DURING ADVANCEMENT OVER THE GW. THE GW AND BALLOON HAD TO BE REMOVED FROM THE PATIENT AS A SINGLE UNIT. AFTER REMOVAL, ISSUES WERE NOTED WITH COATING COMING OFF THE GUIDE WIRE, RESULTING IN THE DIFFICULTY TRACKING THE BALLOON. ADDITIONAL INFORMATION WAS RECEIVED THAT IT WAS THE BLACK POLYMER COATING THAT WAS COMING OFF THE GW. IT COULD NOT BE CONFIRMED WHETHER OR NOT COATING REMAINED IN THE PATIENT. ANOTHER GW WAS USED IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18457053 ↗
• InjuryJan 3, 2024Entrapment of Device; Difficult to Remove; Material Separation; Difficult to Advance; Entrapment of Device; Difficult to Remove; Material Separation; Difficult to Advance

  MEDWATCH MW5147741 RECEIVED WHICH STATES: PATIENT WITH CHRONIC SYSTOLIC HEART FAIL LBBB (LEFT BUNDLE BRANCH BLOCK) EF (EJECTION FRACTION) 30-35% EF UNDERWENT A BIV (BIVENTRICULAR) VENTRICULAR DEFIBRILLATOR. DURING THE PROCEDURE THE DISTAL TIP OF THE WHISPER WIRE DISLODGED IN THE AIV (ANTERIOR INTERVENTRICULAR VEIN)/HIGH LATERAL TRIVARY REGION. THE DISTAL TIP SHEARED OFF. MULTIPLE ATTEMPTS MADE TO SNARE THE DISTAL TIP OF THE WIRE OF DIFFERENT MM 4-7 AND 10. UNFORTUNATELY UNSUCCESSFUL WITHOUT SUCCESS. SMALL PERICARDIAL EFFUSION NOTED. SUBSEQUENT TO THE RECEIPT OF THE MEDWATCH, IT WAS REPORTED THAT THE TIP REMAINS IN THE PATIENT AND THE PERICARDIAL EFFUSION WAS SMALL AND WAS ONLY MONITORED. THE PATIENT WAS HOSPITALIZED ONE DAY FOR MONITORING AND THEN THEY WERE STABLE AND DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Pericardial Effusion

  MAUDE report 18440621 ↗
• InjuryDec 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE 014WHISPER EXTRA SUPPORT GUIDE WIRE SEPARATED DURING PLACEMENT OF A REENTRY CATHETER DURING AN ANGIOPLASTY. AN ATTEMPT WAS MADE TO SNARE THE SEPARATED PORTION; HOWEVER, WAS UNSUCCESSFUL. THE SEPARATED PORTION WAS RETAINED IN THE PATIENT WITHIN THE SUB INTIMAL SPACE POST PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18346249 ↗
• MalfunctionAug 22, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING UNLOADING OF THE HI-TORQUE (HT) WHISPER GUIDE WIRE FROM THE SHIPMENT BOX, THE TYVEK POUCH WAS NOTED TO BE OPENED AND NOT SEALED. IT WAS DEEMED UNSTERILE AND NOT UTILIZED. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596234 ↗
• InjuryDec 9, 2022Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A TOTAL OCCLUSION IN THE RIGHT CORONARY ARTERY (RCA). DURING ADVANCEMENT RESISTANCE WAS MET AND THE TIP OF THE WHISPER GUIDE WIRE SNAPPED OFF. THE SEPARATED PORTION WAS NOT RETRIEVED AND LEFT EMBEDDED IN THE RCA LESION. ANOTHER GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15954291 ↗
• MalfunctionAug 24, 2021Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE 4.0 X 18 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ADVANCED OVER THE WHISPER EXTRA SUPPORT GUIDE WIRE. RESISTANCE WAS NOTED DURING ADVANCEMENT, AND THE STENT DELIVERY SYSTEM BECAME STUCK. THE STENT DELIVERY SYSTEM COULD NOT BE REMOVED FROM THE GUIDE WIRE. BOTH DEVICES WERE REMOVED AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12363049 ↗
• MalfunctionJan 14, 2021Peeled/Delaminated; Difficult to Remove; Peeled/Delaminated; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. AT THE END OF THE PROCEDURE, THE WHISPER GUIDE WIRE WAS REMOVED. SOME RESISTANCE WAS NOTED DURING REMOVAL OF THE GUIDE WIRE, THOUGHT TO BE DUE TO THE PATIENT ANATOMY. IT WAS NOTED THAT THE OUTER COATING WAS SCRAPED DURING REMOVAL; HOWEVER, THERE DID NOT APPEAR TO BE ANY COATING LEFT IN ANATOMY. NO ADDITIONAL INTERVENTION PERFORMED. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11175114 ↗
• InjuryOct 20, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO PLACE A BIVENTRICULAR LEAD INSERTION. THE WHISPER GUIDE WIRE WAS ADVANCED WITHOUT RESISTANCE INTO THE RIGHT ATRIUM AND IT WAS NOTED THAT THE GUIDE WIRE TIP BECAME KNOTTED AND BROKE OFF. THE SEPARATED TIP TRAVELED AND EMBOLIZED IN THE LEFT VENTRICLE. A SNARE DEVICE WAS USED TO SUCCESSFULLY RETRIEVE THE SEPARATED GUIDE WIRE TIP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism

  MAUDE report 10707603 ↗
• DeathFeb 17, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS CIRCUMFLEX LESION. THE WHISPER EXTRA SUPPORT GUIDE WIRE TIP SEPARATED. THE TIP REMAINS STUCK IN THE VESSEL. THE PATIENT DIED THE SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 9717419 ↗
• MalfunctionFeb 17, 2020Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE WHISPER GUIDE WIRE WAS POSITIONED AT THE 1ST DIAGONAL OF THE LEFT ANTERIOR DESCENDING CORONARY (LAD) ARTERY DURING A PROCEDURE. AFTER STENT DEPLOYMENT IN THE PROXIMAL LAD, THE WHISPER GUIDE WIRE HAD RESISTANCE WITH THE STENT DURING REMOVAL, CAUSING THE TIP TO BE STRETCHED. IT WAS CONFIRMED THAT THERE WAS NO SEPARATION OF COILS OR THE CORE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9717185 ↗