Quantum™ Maverick™ H7493808008350Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 08714729392583), received between Nov 11, 2016 and Dec 15, 2025 — classified as 1 injury, 34 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Nonstandard Device; Failure to Advance; Nonstandard Device; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25NOV2025. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.5MM X 8MM FG QUANTUM MAVERICK BALLOON CATHETER T WAS ADVANCED FOR DILATATION. HOWEVER, DURING TRACKING, THE DEVICE FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE BALLOON HAD RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23809726 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT WAS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE RIGHT LOWER LIMB. A 3.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON ROD WAS FOUND TO BE FRACTURED. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20163413 ↗
• MalfunctionSep 21, 2023Break; Material Rupture; Material Integrity Problem; Break; Material Rupture; Material Integrity Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. UPON UNPACKING OF A 3.5MM X 8MM FG QUANTUM MAVERICK BALLOON CATHETER, IT WAS NOTED THAT THE DEVICE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE TIP OF THE DEVICE WAS KINKED, AND THE BALLOON WAS RUPTURED AND NOT A SHAFT BREAK AS WHAT PREVIOUSLY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17795090 ↗
• MalfunctionJan 18, 2023Contamination; Packaging Problem; Contamination; Packaging Problem

  IT WAS REPORTED THAT THE DEVICE PACKAGING WAS NOT STERILE. THE PATIENT PRESENTED FOR PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE; HOWEVER, THE STERILE PACKAGE WAS FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16195690 ↗
• MalfunctionOct 26, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS OPENED; HOWEVER, IT WAS NOTICED THAT THE SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15672779 ↗
• MalfunctionMar 24, 2022Defective Device; Defective Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01-MAR-2022. IT WAS REPORTED THAT THE DEVICE WAS DAMAGED. A 3.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, AFTER UNPACKING, IT WAS FOUND THAT THE DEVICE WAS DAMAGED AND COULD NOT BE USED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A HYPOTUBE SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13895242 ↗
• MalfunctionMar 11, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22-FEB-2021. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED AND SHAFT KINK OCCURRED. THE 85% STENOSED, 15MM X 3.7MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL END OF THE LEFT CIRCUMFLEX (LCX). A 3.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE DEVICE COULD NOT CROSS THE LESION AND IT WAS NOTED THAT THE BALLOON DELIVERY SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT SEPARATION. IT WAS FURTHER REPORTED THAT DURING ADVANCING THE SHAFT SEPARATED INSIDE PATIENT. THE DEVICE WAS REMOVED DIRECTLY AND SLOWLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11464741 ↗
• MalfunctionFeb 16, 2021Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28-JAN-2021. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 3.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, THE SHAFT GOT KINKED. THE DEVICE WAS COMPLETELY REMOVED BY SIMPLY PULLING OUT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A COMPLETE SHAFT SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11335594 ↗
• MalfunctionFeb 15, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 83% STENOSED TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX CORONARY ARTERY. A 3.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE DEVICE WAS FRACTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11328006 ↗
• MalfunctionDec 11, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED, 20-24MM IN LENGTH, 3.5-4.0MM IN VESSEL DIAMETER WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 3.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 15 ATMOSPHERES FOR 20 SECONDS THE BALLOON BURST. THE DEVICE WAS REMOVED WITHOUT PROBLEM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10992271 ↗
• MalfunctionNov 5, 2020Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED MIDDLE AND DISTAL END OF RIGHT CORONARY ARTERY. A 3.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. THE GUIDEZILLA GUIDE EXTENSION CATHETER WAS LIFTED UP HOWEVER, IT BECOME STUCK WITH THE BALLOON AND THE BALLOON SHAFT WAS DAMAGED. THE DEVICE WAS SIMPLY REMOVED NAD THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10791226 ↗
• MalfunctionSep 30, 2020Break; Break

  IT WAS REPORTED THAT BALLOON FRACTURE OCCURRED. THE 85% STENOSED, 3.5MM X 20MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, THE BALLOON WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10610958 ↗
• MalfunctionAug 5, 2020Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16JUL2020 IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 90% STENOSED, 9MM X 3.5MM, TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, THE DELIVERY SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10369198 ↗
• MalfunctionJun 10, 2020Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16 MAY 2020. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 3.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS USED IN A PROCEDURE. HOWEVER, IT WAS NOTICED THAT THE DELIVERY SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10140288 ↗
• MalfunctionApr 23, 2020Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01-APR-2020. IT WAS REPORTED THAT ADVANCING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS USED BUT FAILED TO ADVANCE TO THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9992639 ↗
• MalfunctionFeb 24, 2020Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND SHAFT BREAK OCCURRED. A 3.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST AND THE SHAFT FRACTURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9746077 ↗
• MalfunctionFeb 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED, 20-24X3.5-4MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY. A 3.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. 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 9663226 ↗
• MalfunctionDec 9, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27NOV2019. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 3.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE DELIVERY SHAFT OF THE BALLOON WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9439522 ↗
• MalfunctionSep 5, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 13-AUG-2019. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 85% STENOSED, 8X3.5MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE HYPOTUBE WAS KINKED AFTER ENTERING THE GUIDE CATHETER. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8966530 ↗
• MalfunctionJun 7, 2019Break; Failure to Advance; Break; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14-MAY-2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION; HOWEVER, THE DEVICE 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 SEPARATION. IT WAS FURTHER REPORTED THAT THE FRACTURE OCCURRED DURING THE PROCEDURE AND OUTSIDE THE PATIENT'S BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8679213 ↗
• MalfunctionJun 5, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30MAY2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 85% STENOSED, 20MM X 3.5MM, ECCENTRIC AND DE NOVO TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. AFTER AN UNKNOWN GUIDEWIRE WAS INSERTED, A 3.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A SHAFT DETACHMENT/SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8672108 ↗
• MalfunctionDec 14, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED, 23MM IN LENGTH TARGET LESION WAS LOCATED IN THE LIGHTLY TORTUOUS, CALCIFIED, AND 3.5MM IN DIAMETER LEFT CIRCUMFLEX ARTERY. A 3.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING WITHDRAWAL OF THE DEVICE, IT WAS NOTED THAT THE DELIVERY SHAFT WAS FRACTURED. NO SEGMENT OF THE DEVICE REMAINED INSIDE THE PATIENT. 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 8164787 ↗
• MalfunctionDec 12, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 21-NOV-2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED, 12X3.5MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY. A 3.5MM X 8MM 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 SEPARATION. DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF THE PROXIMAL PORTION OF THE QUANTUM MAVERICK BALLOON CATHETER. ONLY THE HUB, HYPOTUBE AND MIDSHAFT WERE RETURNED FOR ANALYSIS. THE DISTAL SHAFT DISTAL OF THE MIDSHAFT BOND, BALLOON, MARKERBANDS AND TIP WERE NOT RETURNED FOR ANALYSIS. THE SHAFT AND HYPOTUBE WERE MICROSCOPICALLY AND VISUALLY EXAMINED. CONTRAST WAS PRESENT IN THE MIDSHAFT OF THE DEVICE. THERE WERE NUMEROUS KINKS THROUGHOUT THE HYPOTUBE OF THE DEVICE. THE SHAFT WAS DETACHED AT THE MIDSHAFT AND THE MIDSHAFT WAS STRETCHED ON THE HYPOTUBE. INSPECTION OF THE DEVICE PRESENTED NO DAMAGE OR IRREGULARITIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8157831 ↗
• MalfunctionDec 3, 2018Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE THE DELIVERY SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. DEVICE EVALUATED BY MFR.: THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED THAT THE HYPOTUBE IS SEPARATED 72.2CM FROM THE HUB. THERE IS A KINK 69.5CM FROM THE HUB. MICROSCOPIC EXAMINATION REVEALED THAT THE TIP IS DAMAGED AND APPEARS TO BE FLATTENED A LITTLE. THE BALLOON IS STILL TIGHTLY FOLDED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. PRODUCT ANALYSIS CONFIRMED THE HYPOTUBE IS SEPARATED BUT APPEARED TO BE KINKED PRIOR TO SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8126038 ↗
• MalfunctionOct 23, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION 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 SHAFT BREAK. RETURNED PRODUCT CONSISTED OF A QUANTUM MAVERICK BALLOON CATHETER. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED MULTIPLE KINKS ON THE HYPOTUBE. THE HYPOTUBE IS SEPARATED 70.6CM FROM THE HUB. MICROSCOPIC EXAMINATION DID NOT REVEAL ANY DAMAGES. THERE IS BLOOD PRESENT IN THE GUIDEWIRE LUMEN AND THE BALLOON IS STILL TIGHTLY FOLDED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY DAMAGE OR IRREGULARITIES CONTRIBUTING TO THE REPORTED CROSSING DIFFICULTY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7995978 ↗

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-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
• 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