Quantum™ Maverick™ H7493808012400Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08714729392712), received between Dec 8, 2016 and Dec 22, 2025 — classified as 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Break” (14 reports).

5 other recalls cover devices cleared under the same FDA submission (P860019); 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A LABELING ISSUE OCCURRED. PRIOR TO THE PROCEDURE, THE HEAD NURSE OPENED THE OUTER PACKAGE OF THE DEVICE AND NOTED THAT THE LABEL INDICATED A 4.0 X 12 MM QUANTUM? MAVERICK?. HOWEVER, THE LABEL ON THE INNER PACKAGE INDICATED A 3.0 X 12 MM QUANTUM? MAVERICK?. THE INNER PACKAGE WAS NOT OPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT REMAINED STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865121 ↗
• MalfunctionJul 15, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MIDDLE RIGHT CORONARY ARTERY IN WHICH SUBTOTAL OCCLUSION WAS OBSERVE BY ANGIOGRAPHY, AND LIPID PLAQUE OF THIN FIBER CAP WAS OBSERVED BY OPTICAL COHERENCE TOMOGRAPHY (OCT). AFTER 3.5 X 34MM NON BSC STENT IMPLANTATION, A 4.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER AND 3.75 X 15MM BALLOON WAS DILATED AND SHAPED. THE STENT WAS FOUND TO HAVE POOR ADHERENCE TO THE WALL AGAIN ON OCT AND THERE WAS NO ABNORMALITY IN THE DEVICE AND DILATION PROCESS. THE 4.0 X 12MM QUANTUM MAVERICK BALLOON WAS USED NEAR THE STENT AND WAS DILATED UNDER MAXIMUM OF 24 ATMOSPHERES. HOWEVER, THE BALLOON SHAFT WAS BROKEN AND THERE WAS NO CONTRAST AGENT DIFFUSION WAS OBSERVED. THE BALLOON WAS REMOVED AND FOUND THAT THE BALLOON ROD/SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH 4.0 X 12MM NON BSC BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19744164 ↗
• InjuryAug 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON FRACTURE OCCURRED AND THE PATIENT EXPERIENCED HYPOTENSION. THE 50% STENOSED, 4MM DIAMETER TARGET LESION WAS LOCATED IN THE TORTUOUS AND MILDLY CALCIFIED CORONARY VESSEL. A 4.0 X 20MM STENT WAS IMPLANTED. A 4.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON MATERIAL WAS BROKEN INTO TWO PARTS FROM THE MIDDLE INSIDE THE CORONARY VESSEL. THE PATIENT'S BLOOD PRESSURE DROPPED, AND DOPAMINE WAS GIVEN TO INCREASE THE BLOOD PRESSURE. MEANWHILE, ANOTHER GUIDEWIRE AND A NON-BOSTON SCIENTIFIC BALLOON CATHETER WERE USED TO REMOVE THE FRACTURED BALLOON MATERIAL FROM THE PATIENT. SUBSEQUENTLY, THE VITAL SIGNS OF THE PATIENT GRADUALLY STABILIZED, AND THE PATIENT WAS RETURNED TO THE WARD SAFELY. THE PATIENT WAS STABLE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 17493685 ↗
• MalfunctionJul 5, 2023Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30JUN2023. IT WAS REPORTED THAT SHAFT KINK OCCURRED. A 4.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USED. HOWEVER, AFTER UNPACKING, IT WAS NOTED THAT THE DEVICE WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE HYPOTUBE WAS DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17262419 ↗
• MalfunctionJun 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED, 3X28MM, CONCENTRIC, DE NOVO TARGET LESION WITH A BEND OF <=45 DEGREES WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 4.0MM X 12MMN QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON BURST. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT BALLOON RUPTURED DURING SECOND INFLATION AT 18 ATMOSPHERES FOR 15 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17207068 ↗
• MalfunctionApr 18, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. FOLLOWING STENT PLACEMENT, A 4.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. HOWEVER, AFTER IMAGING WHEN THE PHYSICIAN PREPARED TO PLACE THE BALLOON, THE BALLOON SHAFT WAS FOUND TO BE FRACTURED AND UNUSABLE. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14138909 ↗
• MalfunctionOct 19, 2021Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08-OCT-2021. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE DEVICE WAS UNABLE TO INFLATE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12661649 ↗
• MalfunctionJul 12, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28JUN-2021. IT WAS REPORTED THAT SHAFT KINK OCCURRED AND CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 80% STENOSED, 12MM X 4.00MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 4.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION AND IT WAS NOTED THAT THE SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12154152 ↗
• MalfunctionMay 19, 2021Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07MAY2021. IT WAS REPORTED THAT THE BALLOON WAS DAMAGED. A 4.0MM X 12MM QUANTUM MAVERICK WAS SELECED FOR USE. HOWEVER, IT WAS NOTED THAT THE BALLOON WAS FOUND DAMAGE WHEN UNPACKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11849643 ↗
• MalfunctionMay 14, 2021Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 93% STENOSED, 4MMX13MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 4.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED BUT THE DELIVERY SHAFT WAS KINKED AT 110CM FROM THE PHYSICIAN'S HAND. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829484 ↗
• MalfunctionFeb 4, 2021Inflation Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14-JAN-2021. IT WAS REPORTED THAT INFLATION FAILURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A NON-BOSTON SCIENTIFIC CORPORATION STENT WAS IMPLANTED WHICH DID NOT STICK WELL TO THE VESSEL WALL. A 4.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS THEN ADVANCED FOR POST DILATION, HOWEVER, DURING INFLATION TO 15 ATMOSPHERES FOR 20 SECONDS, THE BALLOON FAILED TO INFLATE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11282718 ↗
• MalfunctionOct 22, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 82% STENOSED, 4.0MM X 26MM TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 4.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 13 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10718081 ↗
• MalfunctionSep 8, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE BALLOON CATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10501214 ↗
• MalfunctionSep 25, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS FRACTURED INSIDE THE PATIENT. THE DEVICE WAS WITHDRAWN IN TIME AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9119522 ↗
• MalfunctionSep 5, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12AUG2019. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 95% STENOSED, 12MM IN LENGTH TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED 4.0MM IN DIAMETER LEFT ANTERIOR DESCENDING ARTERY. A 4.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE DELIVERY SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SHAFT BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8964865 ↗
• MalfunctionAug 30, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 4.0MMX12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE DELIVERY SHAFT WAS FRACTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8951190 ↗
• MalfunctionJul 5, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON ENTERING, THE DEVICE INTO THE PATIENT'S BODY, THE DEVICE WAS FRACTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8764539 ↗
• MalfunctionJun 28, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 31MAY2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 85% STENOSED, 12MMX4.0MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 4.0MMX12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHMENT/SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8744600 ↗
• MalfunctionJun 12, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 4.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE SHAFT BROKE OVER 15CM FROM THE HUB. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY WITHOUT ANY MEDICAL INTERVENTION PERFORMED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8693123 ↗
• MalfunctionMar 13, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED, 13X4.0MM TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT MAIN CORONARY ARTERY. A 4.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE DELIVERY SHAFT OF THE BALLOON WAS FRACTURED. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8417283 ↗
• MalfunctionDec 14, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE BALLOON WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8165601 ↗
• MalfunctionDec 12, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 20NOV2018. IT WAS REPORTED THAT CROSSING DIFFICULTY WAS ENCOUNTERED. THE 90% STENOSED, 12MMX4MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 4.0MM X 12MM QUANTUM MAVERICK WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHMENT. RETURNED PRODUCT CONSISTED OF A QUANTUM MAVERICK BALLOON CATHETER IN TWO PIECES. THE BALLOON WAS LOOSELY FOLDED. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE MICROSCOPICALLY EXAMINED. THE HYPOTUBE WAS COMPLETELY SEPARATED 27.1CM FROM THE HUB. THE HYPOTUBE FRACTURE SURFACES WERE OVALED AND TORN, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. THERE ARE NUMEROUS HYPOTUBE AND SHAFT KINKS. THE TIP IS DAMAGED. THERE IS SHAFT DAMAGE AT THE EXIT NOTCH THAT IS CONSISTENT WITH DAMAGE SEEN WITH THE USE OF A GUIDEWIRE. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY DAMAGE OR IRREGULARITIES CONTRIBUTING TO T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8158079 ↗
• MalfunctionNov 8, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE THE MIDDLE PART OF THE HYPOTUBE GOT FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8052137 ↗
• MalfunctionSep 10, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17-AUG-2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED, 4.0MM X 15MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 4.0MM X 12MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7860719 ↗
• MalfunctionAug 15, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED, 12MM IN LENGTH TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS, CALCIFIED, AND 4MM IN DIAMETER LEFT ANTERIOR DESCENDING ARTERY. A 4.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, UPON INFLATION AT 16 ATMOSPHERES, THE BALLOON RUPTURED. NO SEGMENT OF THE BALLOON WAS DETACHED INSIDE THE PATIENT AFTER IT RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7785584 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P860019. One submission often covers many models, so check the product and lot details in each record.

• Z-2165-2008 · May 1, 2007 · Terminated
  Boston Scientific Scimed Maverick 2 Monorail" PTCA Catheter, 3.0 mm 15 mm REF 38928-1530 Lot 9565194 Use before 2010-04 Indicated for balloon dilation of the stenotic portion o
• Z-2166-2008 · Nov 1, 2005 · Terminated
  Boston Scientific Scimed Maverick 2 Monorail 12mm Balloon Catheter, 2.5 mm x 12 mm Made in Ireland Ballybrit Business Park, Galway, Ireland REF 38928-1225 Use before 2007-01 UPN H
• Z-0031-04 · Aug 20, 2003 · Terminated
  Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
• Z-0030-04 · Aug 20, 2003 · Terminated
  Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
• Z-0032-04 · Aug 20, 2003 · Terminated
  Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151