MINI TREK™ 1012269-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 08717648138102), received between Dec 15, 2016 and Mar 24, 2026 — classified as 2 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (34 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, HEAVILY TORTUOUS LEFT CORONARY ARTERY LESION WITH 99% STENOSIS. A 1.5X15 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED BEFORE PATIENT USE AS PER THE INSTRUCTIONS FOR USE WITHOUT ISSUE. THE BDC WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION; HOWEVER, DURING THE FIRST INFLATION AT 10 ATM, THE BALLOON RUPTURED. AN ADDITIONAL NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 24682191 ↗
• MalfunctionMar 19, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 99% STENOSED. DURING ADVANCEMENT OF THE 1.50X15MM MINI TREK BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS ENCOUNTERED BETWEEN THE BALLOON AND THE LESION. ONCE AT THE TARGET LESION FOR PRE-DILATATION, THE MINI TREK BDC RUPTURED AT 6 ATMOSPHERES DURING THE INITIAL INFLATION. THE MINI TREK BDC WAS REMOVED, AND AN UNSPECIFIED TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642728 ↗
• MalfunctionMar 12, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. FOR PRE-DILATATION, THE 1.5X15MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. AT THE TARGET LESION THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE INITIAL INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS CONTINUED WITH ANOTHER TREK BALLOON. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT PROCEDURAL DELAY WAS REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24584228 ↗
• MalfunctionDec 1, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 1.5 X 15 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND RESISTANCE WITH THE ANATOMY WAS NOTED. THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES AND RUPTURED. ANOTHER TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23686844 ↗
• MalfunctionDec 1, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT DEVICE PREPARATION OF THE 1.5X15 MM TREK DILATATION CATHETER WAS PERFORMED ACCORDING TO THE INSTRUCTIONS FOR USE AND NO ISSUES OCCURRED. THE TREK WAS ADVANCED TO THE LESION FOR PREDILATATION IN THE MODERATELY CALCIFIED, HEAVILY TORTUOUS, LEFT CIRCUMFLEX CORONARY ARTERY. SLIGHT RESISTANCE WAS FELT ADVANCING TO THE LESION SITE. DURING THE FIRST INFLATION AT 10 ATM, THE BALLOON RUPTURED. SUBSEQUENTLY, A 2.0X15 MM TREK WAS USED TO DILATE THE LESION. THERE WERE NO ADVERSE EVENTS FOR THE PATIENT AND NO CLINICALLY SIGNIFICANT PROCEDURAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682726 ↗
• MalfunctionOct 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE 1.5X15MM MINI TREK BALLOON DILATATION CATHETER (BDC) PACKAGING WAS ALL INTACT; HOWEVER, THE SHAFT WAS COMPLETELY BENT, SNAPPING INTO TWO PIECES. ANOTHER UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT 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 23409937 ↗
• MalfunctionOct 2, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  SUBSEQUENTLY, AFTER THE INITIAL REPORT HAD ALREADY BEEN FILED, RESISTANCE DUE TO ANATOMY WAS NOTED DURING ADVANCEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23203967 ↗
• MalfunctionAug 6, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY. DURING ADVANCEMENT OF A 1.50X15MM MINI TREK RX BALLOON DILATATION CATHETER, RESISTANCE WAS MET DUE TO ANATOMY. ONCE AT THE LESION FOR PREDILATION, THE MINI TREK RX BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. AN UNSPECIFIED TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22733138 ↗
• MalfunctionJul 9, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE 1.50X15MM RX MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES (ATM). THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22457240 ↗
• MalfunctionJun 26, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. THE 1.50X15MM RX MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES (ATM). THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22335618 ↗
• MalfunctionJun 18, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD). A 1.5X15MM MINI TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES AND ADVANCED TO THE LESION THROUGH RESISTANCE; HOWEVER, DURING THE SECOND INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 10ATMS. THEREFORE THE BDC WAS REPLACED WITH A NON-ABBOTT BDC AND THE PROCEDURE WAS CONTINUED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22288134 ↗
• MalfunctionMar 31, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PLAD). A 1.5 X 15 MM MINI TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES AND ADVANCED TO THE LESION; HOWEVER, DURING AN ATTEMPT TO DILATE THE LESION THE BALLOON WAS NOTED TO RUPTURE AT 8ATMS DURING ITS SECOND INFLATION. THEREFORE THE BDC WAS REMOVED AND REPLACED WITH ANOTHER TREK BDC TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733183 ↗
• MalfunctionFeb 6, 2025Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 1.50X15MM RX MINI TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED FOR USE INSIDE THE PATIENT ANATOMY. THE BDC WAS ADVANCED WITH RESISTANCE NOTED DUE TO INTERACTIONS WITH THE ANATOMY. THE BALLOON WAS INFLATED TO 8 ATMOSPHERES (ATM) WITHOUT ISSUE HOWEVER THE BALLOON THEN RUPTURED DURING THE SECOND INFLATION AT 12 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321272 ↗
• MalfunctionJan 23, 2025Inflation Problem; Material Rupture; Improper or Incorrect Procedure or Method; Inflation Problem; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 1.5X15MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS ATTEMPTED TO BE INFLATED TWICE TO 12 ATMOSPHERES (ATM); HOWEVER, THE BALLOON COULD ONLY BE INFLATED HALFWAY. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER MINI TREK BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. RETURN DEVICE ANALYSIS FOUND A PINHOLE RUPTURE WAS NOTED IN THE BALLOON OF THE BDC AT 4ATM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219575 ↗
• MalfunctionDec 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE PROXIMAL LEFT CIRCUMFLEX (PLCX) ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 1.5X15MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER TREK BALLOON AND ROTABLATION WAS USED IN CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21037767 ↗
• MalfunctionDec 11, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE MID LEFT ANTERIOR DESCENDING ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 99% STENOSIS. THE 1.5X15MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER THE INSTRUCTIONS FOR USE, AND ADVANCED WITH RESISTANCE FELT FROM THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES WHEN A RUPTURE OCCURRED. ANOTHER TREK BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20906805 ↗
• MalfunctionNov 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY THAT IS 90% STENOSED. THE 1.5 X 15 MM MINI TREK BALLOON DILATATION CATHETER (BDC) RUPTURED AT 6 ATMOSPHERES IN 5 SECONDS DURING THE FIRST INFLATION WHEN ATTEMPTING TO PRE-DILATATE THE LESION. ANOTHER 1.5 X 15 MM MINI TREK BDC RUPTURED AT 6 ATMOSPHERES IN 5 SECONDS, DURING THE FIRST INFLATION WHEN ATTEMPTING TO PERFORM ANGIOPLASTY. ROTABLATION WAS PERFORMED AND A NEW TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800755 ↗
• MalfunctionNov 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY THAT IS 90% STENOSED. THE 1.5X15MM MINI TREK BALLOON DILATATION CATHETER (BDC) RUPTURED AT 6 ATMOSPHERES IN 5 SECONDS DURING THE FIRST INFLATION WHEN ATTEMPTING TO PRE-DILATATE THE LESION. ANOTHER 1.5X15MM MINI TREK BDC RUPTURED AT 6 ATMOSPHERES IN 5 SECONDS, DURING THE FIRST INFLATION WHEN ATTEMPTING TO PERFORM ANGIOPLASTY. ROTABLATION WAS PERFORMED AND A NEW TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800744 ↗
• MalfunctionOct 9, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 99% STENOSIS. THE 1.5X15 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE WITH THE ANATOMY NOTED. THE BALLOON WAS USED FOR PRE-DILATATION; HOWEVER THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 10 ATMOSPHERES. ANOTHER TREK BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408907 ↗
• MalfunctionAug 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE FIRST DIAGONAL ARTERY. THE 1.50X15MM RX MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION; THE BALLOON WAS INFLATED HOWEVER IT RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES. THE BDC WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER TREK. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19938448 ↗
• MalfunctionApr 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE ATRIOVENTRICULAR NODE ARTERY WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. FOR PRE-DILATION THE 1.5X15MM MINI TREK BALLOON DILATION CATHETER (BDC) WAS PREPPED AND ADVANCE TO THE TARGET LESION; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. AFTER ROTABLATION OF THE ARTERY, ANOTHER TREK BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093355 ↗
• MalfunctionApr 2, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY THAT IS 99% STENOSED. THE 1.5X15MM MINI TREK BALLOON DILATATION CATHETER FELT RESISTANCE WITH ANATOMY DURING ADVANCEMENT. THE BALLOON WAS INFLATED TO 9 ATMOSPHERES; HOWEVER RUPTURED. A NEW MINI TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19026003 ↗
• MalfunctionMar 11, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE OBTUSE MARGINAL ARTERY THAT WAS BOTH MODERATELY CALCIFIED AND TORTUOUS AND 90% STENOSED. REPORTEDLY, THE MINI TREK BALLOON RUPTURED IN THE PATIENT DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THERE WAS RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT. A CUTTING BALLOON WAS ALTERNATIVELY USE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18882692 ↗
• MalfunctionJan 4, 2024Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED, HEAVILY CALCIFIED AND HEAVILY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA) LESION. A 1.5X15MM MINI TREK BALLOON DILATION CATHETER (BDC) FAILED TO CROSS THE LESION DUE TO THE ANATOMY. RESISTANCE WAS ALSO MET WITH ANATOMY DURING REMOVAL OF THE BDC. ANOTHER DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18447499 ↗
• MalfunctionMar 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MILDLY CALCIFIED DISTAL LEFT CIRCUMFLEX ARTERY THAT WAS 75% STENOSED. THE 1.5-15MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION FOR PRE-DILATATION BUT RUPTURED AT 8 ATM DURING THE FIRST INFLATION. THE BDC WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY. MULTIPLE BALLOONS WERE USED AND A STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492155 ↗