HI-TORQUE WHISPER 1005357HRecalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 08717648037801), received between Sep 15, 2016 and Sep 29, 2026 — classified as 1 death, 36 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Separation” (26 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 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Difficult to Remove; Material Separation

  It was reported that the procedure was to treat the mid left anterior descending (mLAD) artery. The Whisper guide wire (GW) was being used in the procedure with a non-Abbott imaging catheter. Resistance occurred when attempting to remove the imaging catheter from the Whisper GW and the GW separated in half. Both parts of the GW were simply removed with the imaging catheter as a single unit. Another Whisper GW was used to continue the procedure. There was no adverse patient effect. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927336 ↗
• InjuryAug 27, 2026Material Separation

  It was reported the procedure was to perform electrophysiology in the coronary artery. The Whisper MS guide wire was used in the patient however after the guide wire was removed, fluoroscopy confirmed that a portion of the guide wire remained in the patient. Several attempts were made to retrieve the separated portion with partial success. A small fragment migrated to the distal pulmonary artery and was determined to be too far to retrieve therefore it was left in the patient. Per the physician, the remaining portion was not expected to cause clinical issues for the patient. A delay in the procedure was reported. No additional information was provided.

  Patient problems: Foreign Body In Patient

  MAUDE report 50472762 ↗
• InjuryJul 9, 2026Difficult to Remove; Material Separation; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). THE WHISPER MS GUIDE WIRE WAS ADVANCED HOWEVER LOST ACCESS FIVE TIMES AND DURING REMOVAL RESISTANCE WAS NOTED. THE GUIDE WIRE SEPARATED AND WAS FLOATING IN THE PROXIMAL RCA. THE SEPARATED PORTION WAS UNABLE TO BE SNARED THEREFORE THE PATIENT WILL BE SENT FOR SURGERY TO REMOVE THE SEPARATED PORTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25763842 ↗
• InjuryDec 16, 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 THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE WHISPER GUIDE WIRE WAS USED WITH A MICRO CATHETER AND DURING ADVANCEMENT, RESISTANCE WAS NOTED WITH THE VERY CALCIFIED ANATOMY. UPON REMOVAL, THERE WAS RESISTANCE WITH THE VERY CALCIFIED ANATOMY AND THE WHISPER GUIDE WIRE TIP WAS STUCK AND SNAPPED OFF IN THE VESSEL. IT TOOK ABOUT 4 TO 5 HOURS TO RETRIEVE ONE OF THE SEPARATED PIECES VIA SNARE AND THE OTHER PIECE WAS STENTED TO THE VESSEL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20946536 ↗
• InjurySep 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT CIRCUMFLEX CORONARY ARTERY WITH 100% OCCLUSION, MODERATE CALCIFICATION AND MILD TORTUOSITY. THROUGH AN UNSPECIFIED 6 FR SHEATH, A 0.14 WHISPER GUIDE WIRE (GW) AND AN UNSPECIFIED 1.5X15MM DILATATION CATHETER BALLOON WERE ADVANCED. DURING REMOVAL OF THE BALLOON, THE DISTAL TIP OF THE GW SEPARATED AND WAS ABLE TO BE RETRACTED TO THE DISTAL PART OF AN UNSPECIFIED 6FR GUIDELINER. THEN A 2.0 X 6M TREK RX BALLOON DILATION CATHETER WAS ADVANCED ALONGSIDE THE GW TO TRAP AND REMOVE THE SEPARATED DEVICE. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20301359 ↗
• InjuryApr 30, 2024Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT DURING A PACEMAKER PLACEMENT PROCEDURE, THE WHISPER GUIDE WIRE (GW) WAS ADVANCED WITHOUT ISSUE; HOWEVER, WHILE THE PACEMAKER WAS ADVANCED OVER THE GW, RESISTANCE WAS FELT AND THE PACEMAKER LEAD BECAME CAUGHT WITH THE WHISPER GW TIP, RESULTING IN THE WHISPER TIP SEPARATING IN THE PACEMAKER. THE TIP OF THE GW REMAINED INSIDE THE PACEMAKER LEAD IN THE PATIENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19214146 ↗
• InjuryFeb 16, 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 DISTAL CIRCUMFLEX ARTERY LESION. A HT WHISPER GUIDE WIRE WAS ADVANCED AND RETRACTED WITH RESISTANCE NOTED WITH THE IMPELLA DEVICE. THE TIP OF THE WHISPER GUIDE WIRE SHEARED OFF IN THE CIRCUMFLEX ARTERY DURING INTERVENTION. THE PHYSICIAN DETERMINED THE RISK OF PERFORATION WAS TOO HIGH THEREFORE NO ATTEMPTS WERE MADE TO SNARE THE SEPARATED PORTION OF THE GUIDE WIRE. THE DISTAL END OF THE GUIDE WIRE REMAINS EMBEDDED IN THE CIRCUMFLEX ARTERY. KISSING BALLOONS AND ANOTHER WHISPER GUIDE WIRE WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18727335 ↗
• MalfunctionNov 1, 2023Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY (DLAD) WITH HEAVY CALCIFICATION, HEAVY TORTUOSITY AND 90% STENOSIS. THE 014 WHISPER MS GUIDE WIRE FAILED TO CROSS THE LESION AND THE CORE WAS NOTED KINKED. THERE WAS RESISTANCE DURING ADVANCEMENT AND REMOVAL DUE TO THE ANATOMY. THE LESION WAS LEFT UNTREATED. 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 18051380 ↗
• MalfunctionJul 19, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED DE NOVO LESION IN THE DISTAL LEFT CIRCUMFLEX (DLCX) WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. A BMW GUIDEWIRE (GW) WAS POSITIONED AND A TREK BALLOON WAS USED FOR LESION PRE-DILATATION. THEN, THE 014 WHISPER GW WAS POSITIONED. THE 2.50X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT FAILED TO REACH THE LESION AS IT BECAME STUCK AND CAUGHT WITH THE WHISPER GW. THE GW AND SDS WERE REMOVED TOGETHER FROM THE ANATOMY. A KINK ON THE MONORAIL LUMEN OF THE SDS WAS NOTED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A 2.25MM XIENCE SKYPOINT STENT AND A NON-ABBOTT GW WERE USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15059982 ↗
• InjuryJul 13, 2022Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, 85% STENOSED LESION IN THE FIRST OBTUSE MARGINAL (1ST OM) ARTERY. A 014 WHISPER MS GUIDE WIRE (GW) WAS AT THE TARGET LESION WHEN THE PHYSICIAN LOST GUIDE WIRE ACCESS AFTER IMPLANTATION OF AN UNSPECIFIED STENT. THE PHYSICIAN ATTEMPTED TO PUSH THE GUIDE WIRE BACK THROUGH A STENT WHEN IT BECAME CAUGHT IN THE NEWLY IMPLANTED STENT AND COULD NOT BE REMOVED. THE TIP OF THE GUIDE WIRE SEPARATED, AND THE TIP REMAINS PINNED IN THE PATIENT ANATOMY. THE PLAN WAS TO STENT ACROSS IT BUT SINCE NOTHING WOULD CROSS NOT EVEN A BALLOON, SO THE WIRE WAS LEFT PINNED BEHIND THE STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15009300 ↗
• InjuryNov 22, 2021Break; Break

  USER FACILITY MEDWATCH REPORT RECEIVED STATES " MICRO-CATHETER FRACTURED WHILE IN USE ON PATIENT. FDA SAFETY REPORT ID (B)(4)." SUBSEQUENTLY, TO THE INITIAL REPORT BEING FILED THE DEVICE ANALYSIS IDENTIFIED THE CORE AND POLYMER COATING WERE SEPARATED 1.5CM DISTAL FROM THE PROXIMAL END OF THE POLYMER COATING. THERE WAS NO BREAK AS REPORTED. THE SEPARATED PORTION OF THE CORE, POLYMER COATING, AND INCLUDING THE COILS WERE NOT RETURNED; THEREFORE, IT IS UNKNOWN IF ANY PIECES OF THE DEVICE REMAIN IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12855325 ↗
• InjuryJun 21, 2021Off-Label Use; Difficult to Remove; Material Separation; Failure to Advance; Off-Label Use; Difficult to Remove; Material Separation; Failure to Advance

  IT WAS REPORTED THAT DURING A PACEMAKER PROCEDURE RESISTANCE WAS FELT WITH THE ANATOMY DURING ADVANCEMENT OF THE WHISPER GUIDE WIRE, THE GUIDE WIRE DID NOT CROSS THROUGH THE SUPERIOR VENA CAVA. RESISTANCE WAS ALSO FELT AS THE GUIDE WIRE WAS PULLED BACK. THE TIP OF THE GUIDE WIRE SEPARATED, AND A SNARE DEVICE WAS USED IN AN ATTEMPT TO RETRIEVE THE GUIDE WIRE TIP; HOWEVER, THE TIP WAS UNABLE TO BE RETRIEVED. THE TIP REMAINS IN THE ANATOMY. AN UNSPECIFIED GUIDE WIRE WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12037908 ↗
• InjuryMay 26, 2021Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT DURING ADVANCEMENT OF A 014 WHISPER GUIDE WIRE RESISTANCE WAS MET WITH ANATOMY. THE TIP SEPARATED AND AN UNSPECIFIED BALLOON CATHETER WAS USED TO SNARE THE TIP. IT WAS NOTED DURING REMOVAL RESISTANCE WAS MET WITH ANATOMY AND ANOTHER UNKNOWN GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11890244 ↗
• InjuryApr 26, 2021Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: [DURING THE PROCEDURE THE TIP OF THE WHISPER BROKE OFF AND WAS LEFT IN PATIENT AS RISKS OUTWEIGHED BENEFITS TO RETRIEVE WIRE FRAGMENT]. ON 4/21/2021: ADDITIONAL INFORMATION RECEIVED TODAY FROM THE ACCOUNT STATING THAT THE PROCEDURE WAS TO TREAT A LEFT ILIAC ARTERY. THERE WAS RESISTANCE WITH THE ANATOMY WHILE ADVANCING THE GUIDE WIRE WHEN THE TIP BROKE OFF. A STENT WAS USED TO EMBED/CRUSH THE TIP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11729235 ↗
• MalfunctionApr 12, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MILDLY CALCIFIED, MILDLY TORTUOUS, 60% STENOSED LEFT CIRCUMFLEX CORONARY ARTERY. A WHISPER GUIDE WIRE WAS USED WITHOUT ISSUES ON (B)(6) 2021, BUT AFTERWARDS, THE EXPIRATION DATE WAS NOTED TO BE 10/31/2019. 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 11649855 ↗
• MalfunctionMar 8, 2021Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED RIGHT CORONARY ARTERY THAT IS 70% STENOSED. A .014 WHISPER GUIDE WIRE WAS ATTEMPTED TO BE ADVANCED AND BECAME STUCK WITH AN UNSPECIFIED BALLOON CATHETER. BOTH DEVICES WERE RETRIEVED SEPARATELY AFTER MANY TRACTIONS [ATTEMPTED RETRACTIONS] OF THE GUIDE WIRE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440255 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MODERATELY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. A WHISPER MS GUIDE WIRE CROSSED THE LESION, A 2X15MM TREK BALLOON WAS USED FOR PRE-DILATATION, AND A 2.25X23MM XIENCE SIERRA STENT WAS IMPLANTED WITHOUT ISSUE. AS AN UNSPECIFIED PRESSURE WIRE WAS ADVANCED, THE WHISPER GUIDE WIRE MAY HAVE ACCIDENTALLY ADVANCED AND PERFORATED THE VESSEL, SO MEDICATION WAS USED AS TREATMENT. THE PATIENT'S BLOOD PRESSURE DECREASED, SO PERICARDIOCENTESIS AND AN INTRA-AORTIC BALLOON PUMP WERE USED. THE PATIENT WENT INTO CARDIAC ARREST AND EXPIRED THAT SAME DAY(B)(6) 2020 . IN THE OPINION OF THE PHYSICIAN, THE USE OF THESE ABBOTT DEVICES DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH IN ANY WAY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. IN THE OPINION OF THE PHYSICIAN, THE USE OF THESE DEVICES DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 11167256 ↗
• MalfunctionJan 13, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY AND RIGHT CORONARY ARTERY. TWO WHISPER MS GUIDE WIRES WERE USED IN THE PROCEDURE AND IT WAS CONFIRMED THAT NO FLUFF/FABRIC WAS NOTED ON THE GUIDE WIRES PRIOR TO ENTERING THE ANATOMY AS IT WAS PREPPED AND INSPECTED PER THE INSTRUCTIONS FOR USE. IT WAS CONFIRMED THAT THE GUIDE WIRES WERE NOT REMOVED AT ANY POINT DURING THE PROCEDURE TO BE BE WIPED DOWN. HOWEVER, ONCE REMOVED OUT OF THE ANATOMY AS THE PROCEDURE WAS COMPLETED, FABRIC/FLUFF LOOKING MATERIAL WAS NOTED ON BOTH GUIDE WIRES. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11166247 ↗
• MalfunctionJan 13, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY AND RIGHT CORONARY ARTERY. TWO WHISPER MS GUIDE WIRES WERE USED IN THE PROCEDURE AND IT WAS CONFIRMED THAT NO FLUFF/FABRIC WAS NOTED ON THE GUIDE WIRES PRIOR TO ENTERING THE ANATOMY AS IT WAS PREPPED AND INSPECTED PER THE INSTRUCTIONS FOR USE. IT WAS CONFIRMED THAT THE GUIDE WIRES WERE NOT REMOVED AT ANY POINT DURING THE PROCEDURE TO BE WIPED DOWN. HOWEVER, ONCE REMOVED OUT OF THE ANATOMY AS THE PROCEDURE WAS COMPLETED, FABRIC/FLUFF LOOKING MATERIAL WAS NOTED ON BOTH GUIDE WIRES. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11166124 ↗
• InjuryJan 13, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO PLACE A CARDIAC RHYTHM MANAGEMENT IMPLANT. THE WHISPER GUIDE WIRE TIP SEPARATED AND REMAINS EMBEDDED IN THE CORONARY SINUS. A CLINICALLY SIGNIFICANT DELAY WAS REPORTED AS THE PHYSICIAN WAS UNABLE TO SUCCESSFULLY SNARE OR RETRIEVE THE WIRE TIP. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 11158208 ↗
• MalfunctionNov 13, 2020Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE 90% STENOSED, MODERATELY TORTUOUS, MODERATELY CALCIFIED MID-CIRCUMFLEX ARTERY(CX). THE 014 WHISPER GUIDE WIRE (GW) WAS ADVANCED THROUGH A PREVIOUSLY IMPLANTED STENT, WHEN IT BECAME TRAPPED WITH THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. THE GW WAS DIFFICULT TO REMOVE BUT WAS PULLED OUT OF THE ANATOMY WITH THE IVUS CATHETER. UPON REMOVAL, THE DISTAL 10CM OF THE GW WAS COMPLETELY SEVERED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10837403 ↗
• MalfunctionSep 8, 2020Product Quality Problem; Difficult to Remove; Difficult to Advance; Product Quality Problem; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DISTAL CIRCUMFLEX LESION. WHILE ADVANCING AND RETRACTING AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER, FRICTION WAS MET WITH THE WHISPER WIRE. ONCE REMOVED, THE PHYSICIAN NOTED THAT THE WHISPER WIRE HAD A STICKY TACTILE FEEL TO IT. ANOTHER GUIDE WIRE WAS USED TO SUCCESSFULLY 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 Consequences Or Impact To Patient

  MAUDE report 10502797 ↗
• MalfunctionSep 6, 2020Product Quality Problem; Difficult to Remove; Difficult to Advance; Product Quality Problem; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. WHILE ADVANCING AND RETRACTING AN UNSPECIFIED DEVICE, FRICTION WAS MET WITH THE WHISPER GUIDE WIRE. ONCE REMOVED, THE PHYSICIAN NOTED THAT THE WHISPER GUIDE WIRE HAD A STICKY TACTILE FEEL TO IT. ANOTHER GUIDE WIRE WAS USED TO SUCCESSFULLY 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 Consequences Or Impact To Patient

  MAUDE report 10498216 ↗
• InjuryAug 25, 2020Entrapment of Device; Material Separation; Device Damaged by Another Device; Entrapment of Device; Material Separation; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN OBTUSE MARGINAL LESION. POST IMPLANTATION OF AN UNSPECIFIED STENT, A WHISPER MS GUIDE WIRE BECAME TRAPPED UNDER THE DEPLOYED STENT AND THE PROXIMAL PORTION OF THE CORE SNAPPED WHILE ATTEMPTING TO REMOVE IT. THE PATIENT REMAINED STABLE WHILE TRYING TO RETRIEVE THE WIRE, ADDITIONAL CONTRAST/RADIATION WAS EXPERIENCED BY THE PATIENT. FURTHER STENTING WAS PERFORMED TO SECURE THE SEPARATED GUIDE WIRE PORTION. THE PATIENTS HOSPITALIZATION WAS PROLONGED BY A DAY AND SKIN IRRITATION WAS REPORTED DUE TO THE EXTRA RADIATION EXPOSURE. A CLINICALLY SIGNIFICANT DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Rash; Vessel Or Plaque, Device Embedded In

  MAUDE report 10449887 ↗
• InjuryAug 18, 2020Material Separation; Material Separation

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: [MW #(B)(4). PATIENT IN FOR BI-VENTRICULAR AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IMPLANT. DURING THE PROCEDURE, A PIECE OF WHISPER WIRE BROKE INTRACADIAC. THE PIECE WAS RETRIEVED WITH A SNARE SPECIALTY CATHETER BY THE PHYSICIAN. THE PROCEDURE CONTINUED WITHOUT INCIDENT AND THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2020. NO HARM TO PATIENT.]

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10420629 ↗