Quantum™ Maverick™ H7493808020300Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729392897), received between Jan 30, 2018 and Aug 2, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING PREPARATION OF A 3.0MM X 20MM QUANTUM MAVERICK BALLOON CATHETER, IT WAS NOTED THAT THE DEVICE WAS BROKEN. 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 Patient Involvement

  MAUDE report 7744893 ↗
• MalfunctionJul 16, 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 PATIENT PRESENTED WITH INFERIOR ST ELEVATION MYOCARDIAL INFARCTION. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT RADIAL ARTERY. THE TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). AFTER NON-BSC GUIDE CATHETER AND GUIDE WIRE CROSSED THE LESION, PRE-DILATATION WAS PERFORMED 2.5X15 BALLOON CATHETER. A 3X36MM NON-BSC STENT WAS DEPLOYED AT 12 ATMOSPHERES. A 3.0MM X 20MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, THE DEVICE FAILED TO CROSS THE STENT AFTER MULTIPLE ATTEMPTS. APPLYING MORE FORCE ON THE BALLOON CAUSES THE GUIDE CATHETER TO DISLODGE. THE DEVICE WAS REMOVED AND THE PROCEDURE COMPETED WITH A 3X20MM NON-BSC BALLOON CATHETER RESULTING IN TIMI III FLOW INTO THE DISTAL RCA. NO KNOWN 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 7690095 ↗
• MalfunctionJan 30, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.0MM X 20MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. THE BALLOON WAS INITIALLY INFLATED AT 12 ATMOSPHERES; HOWEVER, DURING THE SECOND INFLATION AT 18 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7227786 ↗

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