HI-TORQUE WHISPER 1005357HJRecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 08717648037818), received between Sep 13, 2016 and Dec 3, 2025 — classified as 2 deaths, 18 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 38 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2025Difficult to Remove; Material Separation; Failure to Advance; Difficult to Remove; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT RADIAL ARTERY. THE WHISPER GUIDE WIRE WAS ATTEMPTED TO BE ADVANCED BUT THERE WAS INTENSE RESISTANCE AND IT WAS IMPOSSIBLE TO ADVANCE THE CATHETER AND MANIPULATE THE GUIDE WIRE. THE WHISPER GUIDE WIRE WAS REMOVED WITH THE AID OF THE INTRODUCER DILATOR HOWEVER THERE WAS SIGNIFICANT RESISTANCE AND THE WIRE SEPARATED. A SNARE WAS ATTEMPTED BUT THE WIRE CONTINUED TO BREAK APART. AT THAT TIME, THE ATTEMPTS WERE STOPPED AND THE VASCULAR SURGERY TEAM PERFORMED REMOVAL THROUGH A CUT DOWN OF THE BRACHIAL ARTERY. THE PATIENT UNDERWENT A SURGICAL PROCEDURE UNDER GENERAL ANESTHESIA, WITH AN APPROXIMATELY 10-CENTIMETER INCISION IN THE ARM TO COMPLETELY REMOVE THE FRAGMENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708532 ↗
• InjuryOct 22, 2025Deformation Due to Compressive Stress; Device Damaged by Another Device; Difficult to Advance; Deformation Due to Compressive Stress; Device Damaged by Another Device; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A BIFURCATION IN THE MAIN BRANCH. THE WHISPER GUIDE WIRE WAS ADVANCED TO THE SIDE BRANCH HOWEVER RESISTANCE WAS MET WITH THE PREVIOUSLY IMPLANTED STENT, CAUSING DAMAGE TO THE IMPLANTED STENT. THE WHISPER GUIDE WIRE WAS REMOVED IN ONE PIECE AND A KINK WAS NOTED AT THE TIP. ADDITIONAL INTERVENTION WAS PERFORMED WITH MULTIPLE BALLOONS AND STENT IMPLANTATION AS TREATMENT FOR DAMAGE TO THE IMPLANTED STENT; CAUSING A DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356469 ↗
• MalfunctionAug 21, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CIRCUMFLEX (CX) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE WHISPER MS GUIDEWIRE WAS POSITIONED IN THE CX ARTERY AND ANOTHER WHISPER MS GUIDEWIRE WAS IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. BOTH GUIDEWIRES WERE NOTED TO MOVE TOGETHER AS IF BEING PULLED SIMULTANEOUSLY DUE TO STICKING WHEN ONLY ONE GUIDEWIRE IS BEING RETRACTED. THE GUIDEWIRE WAS STILL REMOVED INDEPENDENTLY AND USED SUCCESSFULLY. AN NC TREK NEO BALLOON WAS ADVANCED AND INFLATED SUCCESSFULLY; HOWEVER, DURING A SECOND INFLATION ATTEMPT TO USE THE BALLOON AT THE BIFURCATION, THE BALLOON WAS UNABLE TO RE-CROSS THE VESSEL/STENT DUE TO THE CROSSING PROFILE OF THE BALLOON. A NEW BALLOON HAD TO BE OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT 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 22867420 ↗
• MalfunctionAug 21, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CIRCUMFLEX (CX) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE WHISPER MS GUIDEWIRE WAS POSITIONED IN THE CX ARTERY AND ANOTHER WHISPER MS GUIDEWIRE WAS IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. BOTH GUIDEWIRES WERE NOTED TO MOVE TOGETHER AS IF BEING PULLED SIMULTANEOUSLY DUE TO STICKING WHEN ONLY ONE GUIDEWIRE IS BEING RETRACTED. THE GUIDEWIRE WAS STILL REMOVED INDEPENDENTLY AND USED SUCCESSFULLY. AN NC TREK NEO BALLOON WAS ADVANCED AND INFLATED SUCCESSFULLY; HOWEVER, DURING A SECOND INFLATION ATTEMPT TO USE THE BALLOON AT THE BIFURCATION, THE BALLOON WAS UNABLE TO RE-CROSS THE VESSEL/STENT DUE TO THE CROSSING PROFILE OF THE BALLOON. A NEW BALLOON HAD TO BE OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT 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 22862116 ↗
• MalfunctionMay 28, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT WHEN ATTEMPTING TO ADVANCE UNSPECIFIED BALLOON CATHETER AND UNSPECIFIED STENT DELIVERY SYSTEM THE DEVICES GET STUCK WITH THE .014 WHISPER GUIDE WIRE. THE DEVICES CANNOT MOVE FORWARD. THEREFORE, AN UNSPECIFIED GUIDE WIRE IS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ADDITIONAL INFORMATION WAS PROVIDED THAT A .014 WHISPER EXTRA SUPPORT GUIDE WIRE AND A .014 WHISPER MS GUIDE WIRE MET RESISTANCE WITH THE BALLOON CATHETER AND STENT DELIVERY SYSTEM AND WOULD GET STUCK. HOWEVER, IT IS UNKNOWN WHICH SPECIFIC GUIDE WIRE BECAME STUCK WITH THE BALLOON OR STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097469 ↗
• MalfunctionMay 19, 2025Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT UPON OPENING THE WHISPER GUIDE WIRE, THE DEVICE WAS NOTED TO BE BROKEN/BENT. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. ANOTHER UNSPECIFIED GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046589 ↗
• InjuryAug 21, 2024Entrapment of Device; Device Damaged by Another Device; Entrapment of Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY INTO THE DIAGONAL. THE .014 WHISPER GUIDE WIRE WAS PLACED FOLLOWED BY THE DEPLOYMENT OF THE 4.0X23MM XIENCE SKYPOINT STENT. WHEN ATTEMPTING TO REMOVE THE GUIDE WIRE IT WAS NOTED TO BE JAILED BY THE STENT. WHEN SNARING OUT THE GUIDE WIRE THE STENT WAS CAME ALONG WITH IT. THEREFORE, A NEW UNSPECIFIED STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20021595 ↗
• MalfunctionNov 15, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED IN A GENERAL COMMENT THAT DURING PROCEDURES OF GREATER COMPLEXITY, THE BALANCE MIDDLEWEIGHT (BMW), BMW UNIVERSAL II, BALANCE HEAVYWEIGHT, WHISPER MS AND WHISPER EXTRA SUPPORT GUIDE WIRES LOSE THEIR HYDROPHILICITY. THERE IS RESISTANCE WITH BALLOONS, STENTS AND IMAGING CATHETERS AND THE GUIDE WIRES ARE SIMPLY REMOVED WITH THE OTHER DEVICE AS A SINGLE UNIT BECAUSE THE DEVICES ARE STUCK TO EACH OTHER. THERE WERE NO ADVERSE PATIENT EFFECTS AND THE LENGTH OF THE PROCEDURE IS EXTENDED AND THERE IS GREATER EXPOSURE TO X RAYS BUT THERE IS NO CONSEQUENCE TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145009 ↗
• MalfunctionNov 15, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED IN A GENERAL COMMENT THAT DURING PROCEDURES OF GREATER COMPLEXITY, THE BALANCE MIDDLEWEIGHT (BMW), BMW UNIVERSAL II, BALANCE HEAVYWEIGHT, WHISPER MS AND WHISPER EXTRA SUPPORT GUIDE WIRES LOSE THEIR HYDROPHILICITY. THERE IS RESISTANCE WITH BALLOONS, STENTS AND IMAGING CATHETERS AND THE GUIDE WIRES ARE SIMPLY REMOVED WITH THE OTHER DEVICE AS A SINGLE UNIT BECAUSE THE DEVICES ARE STUCK TO EACH OTHER. THERE WERE NO ADVERSE PATIENT EFFECTS AND THE LENGTH OF THE PROCEDURE IS EXTENDED AND THERE IS GREATER EXPOSURE TO X RAYS BUT THERE IS NO CONSEQUENCE TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144749 ↗
• MalfunctionApr 24, 2023Break; Break

  IT WAS REPORTED THAT DURING REMOVAL OF THE 014 WHISPER MS 3CM HJ 190 GUIDEWIRE, IT APPEARED THAT THE WIRE HAD BECOME SHEARED, ALTHOUGH WAS REMOVED COMPLETELY INTACT WITH NO IN VIVO RETAINED WIRE. THE ENTIRE WIRE WAS RETRIEVED. THERE WAS NO REPORTED RESISTANCE DURING REMOVAL. USER FACILITY MEDWATCH RECEIVED STATES: "INTERVENTIONAL CARDIOLOGIST WAS COMPLETING A COMPLETE DIAGNOSTIC ELECTROPHYSIOLOGY STUDY WITH CORONARY SINUS CANNULATION, TRANSSEPTAL CATHETERIZATION, ULTRASOUND-GUIDED VENOUS ACCESS, AND 3-DIMENSIONAL ELECTROANATOMIC MAPPING, AND ABLATION FOR VENTRICULAR TACHYCARDIA. DURING PROCEDURE A WHISPER WIRE WAS USED. WHEN RETRIEVING THE WHISPER WIRE, IT DID APPEAR THAT THE WIRE HAD BECOME SOMEWHAT SHEARED, ALTHOUGH THE WIRE DID APPEAR TO BE COMPLETELY INTACT WITH NO IN VIVO RETAINED WIRE. THE ENTIRE WIRE ITSELF WAS RETRIEVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16796947 ↗
• InjuryOct 24, 2022Material Separation; Material Separation

  USER FACILITY MEDWATCH REPORT (MEDSUN MANDATORY AND VOLUNTARY REPORT FORM USER FACILITY REPORT NUMBER: (B)(4) RECEIVED THAT STATES: "DURING CORONARY INTERVENTION, TIP OF THE WHISPER WIRE BROKE OFF IN A DISTAL BRANCH OF THE RCA (DISTAL PDA) AND REMAINED IN DISTAL VESSEL."

  Patient problems: Foreign Body In Patient

  MAUDE report 15664203 ↗
• MalfunctionSep 9, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING PREPARATION, WHEN THE BRAND NEW WHISPER GUIDE WIRE WAS PULLED FROM THE SHELF, THE BOX WAS SEALED BUT WHEN THE POUCH WAS REMOVED IT WAS NOTED THAT THE SEALED SIDE [STERILE SEAL] WAS COMPLETELY OPEN. THERE WAS NO NOTED DAMAGE TO THE POUCH LABEL OR CHIPBOARD BOX. THEREFORE, THE GUIDE WIRE WAS NOT USED AND REPLACED WITH A NEW GUIDE WIRE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396668 ↗
• MalfunctionMay 11, 2022Product 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 LESION IN AN UNSPECIFIED ARTERY WITH MODERATE CALCIFICATION. THE 014 WHISPER GUIDE WIRE (GW) WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE HYDROPHILIC COATING ON THE GUIDEWIRE EXPANDED AFTER 15 MINUTES OF USE, CAUSING THE GUIDEWIRE TO GET STUCK WITH THE INTRAVASCULAR ULTRASOUND CATHETER (IVUS). AFTER REMOVAL OF THE DEVICE, THE PROCEDURE CONTINUED USING A NON-ABBOTT GW. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366276 ↗
• InjuryDec 15, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING ADVANCEMENT OF THE 014 WHISPER GUIDE WIRE THROUGH THE RIGHT CORONARY ARTERY THE TIP SEPARATED. SEVERAL REMOVAL ATTEMPTS WERE MADE; HOWEVER, THE TIP COULD NOT BE RETRIEVED. AN UNSPECIFIED STENT WAS USED TO EMBED THE TIP INTO THE VESSEL WALL. THERE WAS NO REPORTED DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13012227 ↗
• InjuryJun 8, 2021Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT CIRCUMFLEX ARTERY. A 014 WHISPER GUIDE WIRE WAS USED; HOWEVER, DURING REMOVAL RESISTANCE WITH THE ANATOMY WAS FELT AND THE TIP SEPARATED. A SNARE WAS USED TO REMOVE THE SEPARATED PORTION FROM THE PATIENT. A SECOND 014 WHISPER GUIDE WIRE WAS USED, BUT IT WAS OBSERVED THAT IT HAD ALMOST SHEARED. DUE TO THE ISSUE WITH THE FIRST TWO GUIDE WIRES, THE THIRD SELECTED 014 WHISPER GUIDE WIRE WAS NOT USED. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11962411 ↗
• MalfunctionJun 8, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT CIRCUMFLEX ARTERY. A 014 WHISPER GUIDE WIRE WAS USED; HOWEVER, DURING REMOVAL RESISTANCE WITH THE ANATOMY WAS FELT AND THE TIP SEPARATED. A SNARE WAS USED TO REMOVE THE SEPARATED PORTION FROM THE PATIENT. A SECOND 014 WHISPER GUIDE WIRE WAS USED, BUT IT WAS OBSERVED THAT IT HAD ALMOST SHEARED. DUE TO THE ISSUE WITH THE FIRST TWO GUIDE WIRE, THE THIRD SELECTED 014 WHISPER GUIDE WIRE WAS NOT USED. IT WAS THOUGHT THAT THE ISSUE COULD BE SPECIFIC TO THE LOT NUMBER. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962405 ↗
• InjuryMar 18, 2021Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method

  USER FACILITY MEDWATCH REPORT (B)(4) RECEIVED STATING: PATIENT TO CATH LAB FOR HEART CATH WITH PERCUTANEOUS CORONARY INTERVENTION OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. STENT WAS SUCCESSFULLY PLACED IN LEFT DESCENDING CORONARY ARTERY, BUT THEN DISSECTION WAS NOTED. MULTIPLE STENTS WERE DEPLOYED, AND THEN DISSECTION NOTED AT MAIN CORONARY ARTERY, AND THEN LEFT CIRCUMFLEX CORONARY ARTERY. AFTER STENTS DEPLOYED, PATIENT DECOMPENSATED AND CPR WAS STARTED. IMPELLA WAS PLACED, AND BALLOON INFLATIONS INTO CIRCUMFLEX ARTERY WERE PERFORMED. THEY PERFORMED A COUPLE OF BALLOON INFLATIONS WITH THE 2 X 15 MM EMERGE BALLOON IN THE LEFT CIRCUMFLEX. THIS WAS DONE OVER A WHISPER WIRE, WHICH WAS ADVANCED INTO THE LEFT CIRCUMFLEX. AT THIS TIME, THE WHISPER WIRE TIP BECAME ENTANGLED IN THE LEFT MAIN STENT AND THE END OF IT SHEARED OFF. IT WAS RETRIEVED WITH EN SNARE DEVICE. THEY WERE ABLE TO RESTORE FLOW IN THE LEFT CIRCUMFLEX WITH BALLOON INFLATIONS. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THE PATIENT DECOMPENSATED PRIOR TO WIRING THE LEFT CIRCUMFLEX ARTERY (LCX), RESULTING IN PROLONGED HOSPITALIZATION. THE SLOW FLOW IN THE LCX WAS BEFORE WIRING WITH THE WHISPER. NO ADDITIONAL IN

  Patient problems: Vascular Dissection

  MAUDE report 11521630 ↗
• MalfunctionJan 6, 2021Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). WHILE ADVANCING A 3.5X18MM XIENCE ALPINE DRUG ELUTING STENT (DES) OVER A 0.014 WHISPER GUIDE WIRE (GW), THROUGH A NON-ABBOTT GUIDE CATHETER, THE GUIDE CATHETER BROKE. UPON ATTEMPTED REMOVAL OF THE DEVICES, IT WAS NOTED THAT THE STENT COULD NOT BE REMOVED FROM THE GW, RESULTING IN DEFORMATION OF THE STENT. THE DEVICES WERE ULTIMATELY ABLE TO BE REMOVED WITHOUT INTERVENTION, AND ANOTHER WIRE AND STENT WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11125630 ↗
• InjuryJan 6, 2021Material Separation; Device Damaged by Another Device; Material Separation; Device Damaged by Another Device

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A DE NOVO LESION IN THE CIRCUMFLEX (CX) ARTERY WITH HEAVY CALCIFICATION, THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY, AND THE LEFT MAIN ARTERY WITH WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. A 190 CM WHISPER GUIDE WIRE (GW) WAS ADVANCED TO THE LAD. BALLOON ANGIOPLASTY WAS PERFORMED IN THE LAD, LEFT MAIN, AND THE CX ARTERY. THEN A 2.5 X 18MM XIENCE ALPINE STENT WAS IMPLANTED IN THE CX AND A 3.5X48MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS IMPLANTED IN THE LAD. THE KISSING BALLOON TECHNIQUE WAS USED BETWEEN THE LAD AND CX WITH ANGIOPLASTY IN THE LEFT MAIN ARTERY AND A 4MM UNSPECIFIED BALLOON. THEN A 3.0X12 UNSPECIFIED STENT WAS IMPLANTED IN THE AORTA OSTIAL JUNCTION OF THE LEFT MAIN ARTERY AND EXPANDED WITH A 4MM UNSPECIFIED BALLOON. HOWEVER, DURING THE PROCEDURE THE WHISPER GW BECAME SEPARATED IN THE LAD; AND THEREFORE THE PROXIMAL PORTION OF THE SEPARATED GW WAS REMOVED AND THE REMAINDER PORTION OF THE GW WAS REMOVED WITH A 20MM SNARE. THEN DURING THE SNARING PROCESS, THE IMPLANTED XIENCE XPEDITION STENT BECAME WRINKLED. AN ADDITIONAL STENT WAS IMPLANTED TO CORREC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11124550 ↗
• InjuryOct 29, 2020Material Separation; Material Separation

  USER FACILITY MEDWATCH REPORT RECEIVED STATES THAT "IN ATTEMPTS TO DECLOTT A LEFT FISTULA, THE PHYSICIAN USED A WHISPER WIRE; THE WHISPER WIRE BROKE OFF IN THE FISTULA; THIS WAS REMOVED; THE PATIENT THEN DEVELOPED A LARGE HEMATOMA AND WAS TAKE TO THE OPERATING ROOM. ADDITIONAL INFORMATION WAS RECEIVED FROM THE ACCOUNT STATING THE SEPARATED PORTION WAS EMBEDDED IN THE VESSEL DURING SURGERY AND SURGERY WAS ALSO PERFORMED TO TREAT THE HEMATOMA. THE PHYSICIAN NOTED THE HEMATOMA WAS NOT RELATED TO THE FRACTURE NOR WAS THE DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 10758182 ↗
• InjuryOct 22, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT MAIN CORONARY ARTERY. A WHISPER GUIDE WIRE ADVANCED WITHOUT RESISTANCE, BUT THE CORE SEPARATED INTO TWO PIECES. THE WIRE WAS REMOVED, AND THE SEPARATED PORTION WAS SUCCESSFULLY RETRIEVED WITH A SNARE. AN UNSPECIFIED GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10722086 ↗
• InjuryAug 28, 2020Peeled/Delaminated; Off-Label Use; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Peeled/Delaminated; Off-Label Use; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A 014 WHISPER GUIDE WIRE WAS USED THROUGH A QUARTET LV LEAD FOR IMPLANTATION OF A NON-ABBOTT DEVICE FOR OFF-LABEL USE. THE GUIDE WIRE WAS ADVANCED AND INTENTIONALLY JAILED IN THE ANATOMY. WHEN THE GUIDE WIRE WAS REMOVED, THE GUIDE WIRE PUSHED BACK AND THE GUIDE WIRE BECAME STUCK. THE GUIDE WIRE WAS ULTIMATELY REMOVED; HOWEVER, IT WAS NOTED THAT THE COATING PEELED OFF, EXPOSING THE COILS. THE COATING CAME OFF INSIDE THE PATIENT AND NO ADDITIONAL TREATMENT WAS PERFORMED. THE NON-ABBOTT DEVICE WAS IMPLANTED AS INTENDED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10466125 ↗
• InjuryJul 31, 2020Entrapment of Device; Material Separation; Difficult to Advance; Entrapment of Device; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED, HEAVILY TORTUOUS OBTUSE MARGINAL CORONARY ARTERY. A 2.25X12MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY. AN UNSPECIFIED SDS WAS USED ALONG WITH A 190CM WHIPSER GUIDE WIRE, WHICH FELT RESISTANCE DURING ADVANCEMENT WITH THE ANATOMY. THE TIP OF THE GUIDE WIRE HAD BECOME ENTRAPPED WHEN THE STENT WAS DEPLOYED, AND THE GUIDE WIRE TIP SEPARATED DURING REMOVAL. AN UNSPECIFIED STENT WAS USED TO ENTRAP THE SEPARATED PORTION OF THE GUIDE WIRE FULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 10353392 ↗
• InjuryMar 17, 2020Material Separation; Material Too Soft/Flexible; Material Separation; Material Too Soft/Flexible

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9842410 ↗
• InjurySep 26, 2019Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED, MODERATELY TORTUOUS CIRCUMFLEX CORONARY ARTERY. BEFORE THE PROCEDURE, A MINI TREK BDC WAS OPENED DURING PREP AND IT WAS NOTED THAT THE BALLOON WAS SEPARATED FROM THE SHAFT. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A 3.5X23 MM XIENCE SIERRA WAS IMPLANTED WITHOUT ISSUE; HOWEVER, WIRE POSITION WAS LOST AS THE VESSEL CLOSED FOR AN UNKNOWN REASON. A NEW BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS ADVANCED AS WELL AS A WHISPER GUIDE WIRE AND THE WHISPER WAS THOUGHT TO BE IN THE TRUE LUMEN OF THE VESSEL. THE BMW WENT UNDER AND AROUND A COUPLE STRUTS OF THE PREVIOUSLY IMPLANTED XIENCE SIERRA STENT AND OVER THE WHISPER GUIDE WIRE. THE BMW WAS THEN JAILED WITH A 2.25X18 MM XIENCE SIERRA STENT. THE BMW WAS STUCK AND WAS NOT ABLE TO BE REMOVED. BALLOON ANGIOPLASTY WAS ATTEMPTED IN ORDER TO FREE THE GUIDE WIRE BUT IT WAS UNSUCCESSFUL. THE BMW THEN SEPARATED AND COILED INTO A BALL. THE TIP OF THE WHISPER GUIDE WIRE ALSO SEPARATED DUE TO THE BMW GUIDE WIRE WRAPPING AROUND IT. THE SEPARATED PORTIONS OF THE GUIDE WIRES BOTH REMAIN IN THE PATIENT ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9126537 ↗