Wolverine Coronary Cutting Balloon H74939401103000Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 08714729888260), received between Apr 12, 2018 and Jul 28, 2026 — classified as 1 death, 8 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (16 reports).

6 other recalls cover devices cleared under the same FDA submission (P950020); they may or may not involve this specific model.

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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Nonstandard Device; Material Rupture

  It was reported that the balloon burst.A 10mmX3.00mm Wolverine Coronary Cutting Balloon was selected for use. During the procedure, at first inflation, it was noted that the balloon burst. The device was removed without any problem using the normal method and the procedure was completed with another of the same device. There were no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059188 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a dissection type C occurred.The patient was on a prior regimen of Aspirin (>= 72 hours). Before the procedure, the patient received Heparin or other antithrombotic medication and a loading dose of 81 mg of Aspirin. The 2.5 mm x 40 mm target lesion located at the proximal circumflex vessel was pretreated with two devices using the largest balloon diameter 3.0 mm x 30 mm Wolverine cutting balloon and semi-compliant balloon angioplasty catheter resulting in 10% residual stenosis and TIMI flow of 3. The target lesion was then successfully implanted with a 2.5 mm x 38 mm Synergy XD stent achieving 10% stenosis and TIMI flow 3. During the same day of the procedure, it was discovered that post-treatment with the 3.0 mm x 30 mm Wolverine cutting balloon and semi-compliant balloon angioplasty catheter a Grade C dissection with a dissection length of 4.21 mm and dissection stenosis of 34.09% in segment with TIMI Flow 3. No dissection was noted post treatment with the 2.50 mm x 38 mm Synergy XD drug eluting stent. The non-target lesion located at the mid-left anterior descending vessel was also treated prior to the target lesion procedure. It was successfully treated wit

  Patient problems: Vascular Dissection

  MAUDE report 50057669 ↗
• MalfunctionMar 19, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED OSTIAL RIGHT CORONARY ARTERY (RCA). A 3.00MM X 10MM WOLVERINE CORONARY CUTTING BALLOON WAS USED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING INSERTION, THE WOLVERINE DEVICE WAS ADVANCED INTO POSITION TO TREAT THE LESION. HOWEVER, THE MID SEGMENT OF THE DELIVERY STAINLESS STEEL DELIVERY SHAFT SNAPPED AND BROKE APART. THE DEVICE WAS REMOVED FROM THE PATIENT IN ONE PIECE, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641789 ↗
• MalfunctionDec 9, 2025Fluid/Blood Leak; Inflation Problem; Material Rupture; Fluid/Blood Leak; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 10MMX3.00 MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, UPON ENTERING THE BODY, THE BALLOON WAS INFLATED 2 TO 3 TIMES BUT DID NOT FILL PROPERLY AND COULD NOT BE USED. THE BALLOON WAS REMOVED FROM THE BODY, AND UPON INSPECTION, IT WAS FOUND TO HAVE BURST AND LEAKED IMMEDIATELY. THE DEVICE WAS REMOVED SUCCESSFULLY FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760194 ↗
• InjuryDec 8, 2025Difficult to Remove; Material Rupture; Difficult to Advance; Difficult to Remove; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED RESULTING IN PATIENT COMPLICATIONS. THE 85-90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING USE OF A 1.25 ROTA BURR, THE 10MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON CUTTING BALLOON WAS ADVANCED USING GUIDEZILLA DUE TO DIFFICULTY IN ADVANCEMENT. THE WOLVERINE WAS INFLATED AT NOMINAL PRESSURE DISTAL TO THE CALCIFIED LESION. THE BALLOON WAS INFLATED A SECOND TIME DIRECTLY IN THE CALCIFIED LESION, BUT THE BALLOON RUPTURED AT 8 ATMOSPHERES FOR 10 SECONDS, LEAVING ATHERECTOMY BITS EMBEDDED IN THE LESION AND IMPOSSIBLE TO RETRIEVE, RESULTING IN DISSECTION AND VESSEL OCCLUSION. NO BLADES WERE DETACHED. AN ATTEMPT WAS MADE TO COVER THE BALLOON WITH THE GUIDEZILLA, BUT THE GUIDEZILLA WOULD NOT ADVANCE. BAILOUT TECHNIQUES WERE CARRIED OUT WITH A WIRE AND A PARALLEL, NON-BOSTON SCIENTIFIC, BALLOON, WHICH ALSO RUPTURED. THE GUIDEZILLA WAS ADVANCED WITH TWO NON-BOSTON SCIENTIFIC WIRES IN THE PATIENT SUCCESSFULLY COVERING THE DEVICES AND EVERYTHING WAS RETRACTED FROM THE PATIENT. A STENT WAS IMPLANTED TO TREAT THE DISSECTION, AND THE PROCEDURE WAS COMPLETED WITH OTHER DEVICES. THERE WERE

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 23742361 ↗
• MalfunctionMar 26, 2025Entrapment of Device; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. THE 3.00 X 10 MM WOLVERINE CUTTING BALLOON WAS SELECTED FOR USE. AFTER BEING INFLATED SIX TIMES AT 18, 18, 14, 14, 19, AND 12 ATM, THE DEVICE GOT STUCK ON THE TIP OF A GUIDE EXTENSION CATHETER. THE BALLOON WAS INFLATED AND THEN DEFLATED SLOWLY TO TRY TO DISLODGE. THE WOLVERINE WAS THEN PULLED HARD AND WHEN IT WAS REMOVED AND INSPECTED, IT WAS NOTED THAT PART OF A BLADE WAS MISSING. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. THERE WERE NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED CIRCUMFLEX WITH MULTILAYERED STENTS AND ISR. INTRAVASCULAR ULTRASOUND WAS USED BUT WAS NOT SUCCESSFUL IN IDENTIFYING THE LOCATION OF THE DETACHED BLADE. THE GUIDE AND GUIDE EXTENSION CATHETERS WERE REMOVED AND INSPECTED BUT THE MISSING BLADE WAS NOT FOUND. IT IS ASSUMED THE BLADE REMAINED INSIDE THE PATIENT.

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

  MAUDE report 21700750 ↗
• MalfunctionAug 23, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT BALLOON RUPTURE OCCURRED. A 10MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. UPON INSERTION OF THE BALLOON INTO THE GUIDE CATHETER, BLOOD WAS NOTED TO BE LEAKING INTO THE HUB OF THE BALLOON THROUGH THE Y-CONNECTOR. INSPECTION OF THE BALLOON UPON REMOVAL REVEALED A LEAK IN THE DISTAL SHAFT. ADDITIONAL IT WAS NOTED THAT THE BALLOON BURST. THE BALLON WAS WITHDRAWN IMMEDIATELY, AND THE PATIENT WAS NOT ADVERSELY AFFECTED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055564 ↗
• MalfunctionMar 27, 2024Break; Break

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT THE CATHETER SHAFT BROKE. A 10MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PREPARATION, THERE WAS A SEPARATION OF THE SHAFT OF THE DEVICE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18987241 ↗
• MalfunctionFeb 13, 2024Break; Break

  IT WAS REPORTED THAT THE SHAFT WAS SEPARATED. A 10MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON SHAFT SEPARATED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18698313 ↗
• MalfunctionNov 8, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE DEVICE WAS BROKE AND CRACKED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 10MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE COULD NOT CROSS THE LESION. A DIFFERENT BALLOON WAS USED TO CROSS AND EXPAND THE LESION. WHEN USING THE WOLVERINE BALLOON AGAIN THE SHAFT GOT BROKE AND CRACKED WHILE TRYING TO PASS THE LESION. THE DEVICE WAS PULLED OUT COMPLETELY FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18092161 ↗
• MalfunctionSep 21, 2023Material Rupture; Material Deformation; Material Rupture; Material Deformation

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED MID CIRCUMFLEX ARTERY. A 10MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. THE SURGICAL TECHNOLOGIST PREPARED THE BALLOON USING THE STANDARD TECHNIQUE. HOWEVER, THE SHAFT WAS KINKED, AND THE BALLOON RUPTURED OUTSIDE THE BODY. THE PROCEDURE WAS COMPLETED WITH A NEW WOLVERINE OF THE SAME LENGTH AND DIAMETER. IT WAS PREPPED PROPERLY, FUNCTIONED PROPERLY IN THE BODY AND ACHIEVED THE OUTCOME THE PHYSICIAN WAS HOPING FOR. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17793579 ↗
• InjuryMar 9, 2023Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK IN THE VESSEL AND COULD NOT BE REMOVED. THE TARGET LESION WAS LOCATED IN A 360 DEGREES CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 10MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS INFLATED AT 12 ATMOSPHERES AND DEFLATED. HOWEVER, THE DEVICE BECAME STUCK IN THE VESSEL AND COULD NOT BE REMOVED. THE BALLOON WAS INFLATED AND DEFLATED MULTIPLE TIMES AND THEN THE PHYSICIAN ATTEMPTED TO DISLODGE THE BALLOON WITH A WIRE NEXT TO IT. FURTHERMORE, THE PHYSICIAN CUT THE SHAFT AND ADVANCE A SNARE OVER THE SHAFT AND WIRED DOWN TO SECURE THE BALLOON TO PUSH AND PULL THE DEVICE OUT OF THE BODY. THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16519242 ↗
• InjurySep 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT HAD ARRHYTHMIA. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 10MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN THOUGHT DEVICE RUPTURE OCCURRED AT 6 ATMOSPHERES UPON FIRST INFLATION FOR 5 SECONDS BECAUSE CONTRAST FROM BALLOON WENT DOWN VESSEL. THEREFORE, PRE EXISTING AIR IN BALLOON IS POSSIBLE. THE BALLOON WAS TAKEN OUT AND MEDICATION WAS GIVEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT HAD ARRHYTHMIA BUT HAS FULLY RECOVERED.

  Patient problems: Arrhythmia

  MAUDE report 15420375 ↗
• MalfunctionSep 7, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 10MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR TREATING THE 70% STENOSED, MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. WOLVERINE WAS OPENED AND PREPPED; THE SHAFT BROKE INTO TWO SEPARATE PIECES BEFORE BEING INTRODUCED INTO THE PATIENT. AN NC BALLOON CATHETER WAS USED TO COMPLETE THE DILATION TO THE LESION. A 6F GUIDEZILLA II WAS THEN PLACED FOR MORE SUPPORT DURING STENT DELIVERY. A 4.5MM SYNERGY XD STENT WAS THEN ADVANCED INTO THE 6F GUIDEZILLA II BUT FAILED TO ADVANCE THROUGH THE 6F GUIDEZILLA II. IT WAS OBSERVED THAT THE GUIDEZILLA II CATHETER WAS NOT LARGE ENOUGH FOR THE 4.5MM SYNERGY XD STENT AND THAT THE SYNERGY XD STENT POSSIBLY BECAME DEFORMED DURING ADVANCEMENT. THE SYNERGY XD STENT WAS EXCHANGED FOR SMALLER SIZED NON-BSC STENT TO PROCEED WITH THE COMPLETION OF THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15370820 ↗
• MalfunctionDec 2, 2021Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED MID CIRCUMFLEX ARTERY. A 10MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WOULD NOT CROSS THE LESION. A GUIDEZILLA GUIDE EXTENSION CATHETER ADVANCED. HOWEVER, UPON INSERTING THE DEVICE INTO THE GUIDEZILLA, THE SHAFT BROKE AND SEPARATED INTO TWO PIECES WHILE OUTSIDE OF THE PATIENT BODY. THE BREAKAGE WAS CAUSED BY THE KINK NOTED ON THE SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12917070 ↗
• DeathNov 10, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT STUCK IN STENT, SHAFT BREAK, AND DEATH OCCURRED. ON AN UNSPECIFIED DATE, A NON-BOSTON SCIENTIFIC STENT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). ABOUT A MONTH LATER, THE PATIENT PRESENTED WITH AN UNDER-EXPANDED STENT LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LAD. THE PHYSICIAN DECIDED TO USE A 10MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON TO LASER AND THEN EXPAND THE STENT AT HIGH PRESSURE. WHEN THE CUTTING BALLOON WAS INFLATED PAST BURST PRESSURE TO 15 ATM, THE BALLOON GOT STUCK IN THE OLD STENT AND WHEN THE PHYSICIAN PULLED THE DEVICE BACK, THE SHAFT SNAPPED ABOUT 20CM FROM THE HUB. THE DEVICE FRAGMENT WAS REMOVED WITH A SNARE BUT THE IMPLANTED STENT HAD BEEN DEFORMED. A WIRE WAS UNABLE TO PASS THROUGH THE DEFORMED STENT FOR FURTHER INTERVENTION SO THE PROCEDURE WAS CANCELLED. THE PATIENT WAS STABLE POST PROCEDURE BUT DIED THE NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790947 ↗
• InjuryOct 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BLADE DETACHED FROM THE CUTTING BALLOON. A 10MM X 3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. THE WOLVERINE WAS ADVANCED AND INFLATED TWICE AT 12 ATMOSPHERES. ON THE THIRD INFLATION THE LESION WAS NOT YIELDING. THE WOLVERINE WAS INFLATED TO A HIGHER PRESSURE (16 ATM) FOR A COUPLE MORE INFLATIONS. THE WOLVERINE WAS REMOVED. THE LESION WAS THEN SUCCESSFULLY DILATED WITH A 3.5 X 12 EMERGE BALLOON CATHETER. A STENT WAS THEN ATTEMPTED TO CROSS THE LESION MULTIPLE TIMES BUT WAS UNSUCCESSFUL. THE STENT WAS REMOVED AND A GUIDE EXTENSION CATHETER WAS ADVANCED ALONG WITH THE BALLOON CATHETER. THE STENT WAS ADVANCED AND SUCCESSFULLY IMPLANTED. POST PROCEDURE IT WAS OBSERVED THAT THE CENTER PIECE OF THE BLADE WAS MISSING ON THE WOLVERINE CUTTING BALLOON. THE DISTAL AND PROXIMAL PART OF THE BLADE REMAINED ATTACHED TO THE BALLOON. THE PHYSICIAN STATED THAT THE DETACHED BLADE BECAME FIXATED INTO THE WALL AND WAS NOW COVERED AND TRAPPED BEHIND A STENT. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12704394 ↗
• MalfunctionJul 9, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 10MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED UPON SECOND INFLATION AT 8 ATMOSPHERES FOR 15 SECONDS. THE BALLOON WAS PULLED OUT AND COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A SYNERGY STENT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12147106 ↗
• MalfunctionFeb 11, 2021Break; Break

  IT WAS REPORTED THAT THE BALLOON BROKE. A 10MM X 3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. PRIOR THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BROKE IN HALF WHEN TAKEN OUT OF THE BOX. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11317144 ↗
• MalfunctionFeb 4, 2021Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THE CATHETER SHAFT BROKE. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 10MM X 3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, THE DEVICE HAD DIFFICULTY ADVANCING PAST THE LESION, HOWEVER THE CATHETER SHAFT BROKE. THE DEVICE WAS INTACT WHEN REMOVED COMPLETELY FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11278640 ↗
• MalfunctionOct 2, 2020Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE CATHETER SHAFT BROKE. A 10MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE SHAFT KINKED AND BROKE AS THE PHYSICIAN WAS PUSHING IT THROUGH THE TOUHY. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10622119 ↗
• MalfunctionJun 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. THE 99% CALCIFIC TYPE STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. A 10MMX3.00MM WOLVERINE CUTTING BALLOON WAS SELECTED FOR USE. UPON FIRST INFLATION, IT WAS APPARENT THAT THE BALLOON HAD RUPTURED DUE TO THE INABILITY OF THE BALLOON TO MAINTAIN NOMINAL PRESSURE. THE BALLOON WAS THEN REMOVED WITHOUT ANY COMPLICATION AND WAS REPLACED WITH ANOTHER OF THE SAME. THE NEW DEVICE WENT TO THE SAME LOCATION WITHOUT COMPLICATION AND THE DESIRED RESULTS WERE ACHIEVED. STENT WAS PLACED TO COVER TREATED AREA AND PATIENT IS RESTING COMFORTABLY POST PROCEDURE. PER OPERATORS IMPRESSIONS, THE BALLOON MUST HAVE SNAGGED ON SOME CALCIUM AND CAUSED THE TEAR INITIALLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10111213 ↗
• MalfunctionNov 6, 2019Break; Break

  IT WAS REPORTED THAT THE CATHETER SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 10MMX3.0MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, THE BALLOON WAS ADVANCED INTO THE LESION. HOWEVER, THE BALLOON CATHETER SHAFT BROKE INTO HALF BEFORE INFLATION. THE PROXIMAL PART OF THE BALLOON CATHETER WAS THEN REMOVED AND A 2.5MMX16MM EMERGE BALLOON WAS USED. SUBSEQUENTLY, THE EMERGE BALLOON WAS INFLATED AND TRAPPED THE REMAINING WOLVERINE SHAFT INSIDE THE GUIDE CATHETER AND FACILITATED THE REMOVAL OF ALL THE DEVICE COMPONENT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A NEW GUIDE CATHETER AND A NON-COMPLIANT BALLOON. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE.

  Patient problems: No Code Available

  MAUDE report 9284051 ↗
• InjuryOct 2, 2019Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER BROKE AND THE PATIENT WAS SENT TO SURGERY. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 10 MM X 3.00 MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS ADVANCED AND INFLATED JUST DISTAL TO AN UNKNOWN, PREVIOUSLY PLACED 5YR OLD STENT. AFTER DEFLATION, SEVERAL ATTEMPTS WERE MADE TO REMOVE THE DEVICE THROUGH THE STENT BUT WERE UNSUCCESSFUL. SUBSEQUENTLY, AFTER CONTINUING TO PULL, THE DELIVERY CATHETER BROKE FREE FROM THE BALLOON SEGMENT INSIDE THE LESION. SEVERAL ATTEMPTS TO SNARE THE BALLOON WERE MADE BUT FAILED. CONSEQUENTLY, THE PATIENT WAS SENT FOR SURGERY AND THE DEVICE FRAGMENT WAS EVENTUALLY REMOVED. NO FURTHER COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST-SURGERY.

  Patient problems: No Code Available

  MAUDE report 9146965 ↗
• MalfunctionSep 25, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 10MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON CONTAINS BLOOD INSIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE BALLOON CATHETER WAS ALREADY INSIDE THE PATIENT'S BODY WHEN BLOOD WAS NOTED IN THE INFLATION PORT; THUS, THE BALLOON WAS REMOVED IMMEDIATELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9120970 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P950020. One submission often covers many models, so check the product and lot details in each record.

• Z-2137-2013 · Jul 31, 2013 · Terminated
  Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angiopla
• Z-2138-2013 · Jul 31, 2013 · Terminated
  Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #H74
• Z-0621-2009 · Nov 21, 2008 · Terminated
  Flextome Cutting Balloon Device Over-the-Wire Delivery System, Coronary Atherotomy System, Over-the-Wire Delivery System, Catalog No. CB0340006, 4.00mm, Sterile. Made in Ireland:
• Z-1512-06 · Jul 21, 2006 · Terminated
  Boston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston Scientific Place, Natick, MA 01760.
• Z-0409-06 · Dec 7, 2005 · Terminated
  The Flextome Cutting Balloon Device consists of a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Flextome Cutting Ball
• Z-0410-06 · Dec 7, 2005 · Terminated
  The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface.