MINI TREK™ 1012269-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 08717648138096), received between Aug 2, 2016 and Apr 23, 2026 — classified as 3 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (37 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. FOR PRE-DILATION, THE 1.5X12MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE INITIAL INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. 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 24972043 ↗
• MalfunctionApr 3, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE LEFT CIRCUMFLEX ARTERY. THE 1.50X12MM RX MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED. DURING THE FIRST INFLATION AT 8 ATMOSPHERES, A BALLOON RUPTURE OCCURRED. THE BDC WAS REMOVED AND ANOTHER 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 24778790 ↗
• MalfunctionJan 23, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE MID RIGHT CORONARY ARTERY. THE 1.50X12MM RX MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. DURING THE FIRST INFLATION AT 10 ATMOSPHERES, A BALLOON RUPTURE OCCURRED. THE BDC WAS REMOVED AND ANOTHER 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 24160572 ↗
• MalfunctionJan 7, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 1.5X12MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY, AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 10 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS CONTINUED WITH ANOTHER TREK BALLOON. 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 23990345 ↗
• MalfunctionDec 11, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 1.50X12MM 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 6 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 23777220 ↗
• MalfunctionSep 17, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN A UNSPECIFIED CORONARY ARTERY. A 1.5X12MM MINI TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES AND ADVANCED TO THE LESION TO BE USED FOR VESSEL DILATATION. HOWEVER, AFTER THE BDC WAS ADVANCED THROUGH STRONG RESISTANCE WITH THE ANATOMY, THE BALLOON WAS NOTED TO RUPTURE AT 8ATMS DURING THE FIRST INFLATION. THEREFORE THE BDC WAS REMOVED AND A 2.0X12MM AND 2.0X20MM NON-ABBOTT BDC'S WERE USED 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 23078516 ↗
• MalfunctionJul 7, 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 HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 99% STENOSIS. INTRAVASCULAR ULTRASOUND (IVUS) COULD NOT CROSS THE LESION AND THE 1.5X12 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 10 ATMOSPHERES BUT THE BALLOON RUPTURED. A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE. A 2.75X28 MM XIENCE SKYPOINT STENT WAS DEPLOYED. 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 22421207 ↗
• MalfunctionJun 3, 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 ARTERY (LAD). A 1.5X12MM MINI TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES AND ADVANCED TO THE LESION THROUGH RESISTANCE; HOWEVER, DURING THE FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 6ATMS. THEREFORE, THE BDC WAS REMOVED AND A NEW MINI TREK BDC WAS USED TO CONTINUE 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 22132248 ↗
• MalfunctionMar 14, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. THE 1.5X12MM RX MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE NOTED DUE TO INTERACTIONS WITH THE ANATOMY. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 14 ATMOSPHERES. 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 21606690 ↗
• MalfunctionFeb 11, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY THAT IS 96% STENOSED. THE 1.5X12MM MINI TREK BALLOON DILATATION CATHETER MET RESISTANCE WITH ANATOMY DURING ADVANCEMENT. ONCE AT THE LESION THE BALLOON WAS INFLATED TO 8 ATMOSPHERES WHEN IT RUPTURED. A NEW MINI TREK BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS 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 21358246 ↗
• MalfunctionJan 31, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA). AFTER A 1.5X12MM MINI TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER THE INFORMATION FOR USE (IFU), THE BDC WAS ADVANCED TO THE LESION, THROUGH RESISTANCE; HOWEVER, DURING THE FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 8 ATMOSPHERES. THE BDC WAS REMOVED AND A NEW TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21287048 ↗
• MalfunctionNov 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS PROXIMAL LEFT CIRCUMFLEX ARTERY. A 1.20X12MM MINI TREK BALLOON DILATATION WAS ADVANCED FOR PRE-DILATATION; HOWEVER, RUPTURED IN 5 SECONDS DURING THE FIRST INFLATION AT 6 ATMOSPHERES. THEREFORE, A 1.5X12MM MINI TREK BALLOON WAS ADVANCED; HOWEVER, RUPTURED AT 6 ATMOSPHERES IN 5 SECONDS. ROTABLATION WAS PERFORMED AND A NEW TREK BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS 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 20800481 ↗
• MalfunctionNov 20, 2024Material 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 MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A 1.5X12MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER THE INSTRUCTIONS FOR USE, AND ADVANCED WITH RESISTANCE TO THE TARGET LESION; HOWEVER DURING THE FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 8 ATMOSPHERES. THE BDC WAS REMOVED AND ANOTHER TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20733120 ↗
• MalfunctionOct 15, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY THAT IS 100% STENOSED. THE 1.5X12MM MINI TREK BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION WITH RESISTANCE FELT WITH ANATOMY; HOWEVER, DURING THE FIRST INFLATION THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM). ADDITIONAL PRE-DILATATION WAS PERFORMED WITH A 1.2X6MM MINI TREK. AFTER A 3.0X12MM TREK BALLOON DILATATION CATHETER WAS USED FOR DILATATION, BUT THE BALLOON RUPTURED DURING FIRST INFLATION AT 6 ATMS. IT WAS NOTED RESISTANCE WAS FELT WITH ANATOMY DURING ADVANCEMENT OF THE 3.0X12MM TREK. A 3.0X6MM NC TREK BALLOON WAS ATTEMPTED TO BE USED, BUT RUPTURED AT THE THIRD INFLATION AT 10 ATMS. ANOTHER UNSPECIFIED BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS 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 20454702 ↗
• MalfunctionSep 23, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 1.5X12MM MINI TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPPED PER INSTRUCTIONS FOR USE AND ADVANCED WITH RESISTANCE FELT FROM THE PATIENTS ANATOMY. THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES WHEN A RUPTURE OCCURRED. A NON-ABBOTT 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 20285500 ↗
• MalfunctionJul 11, 2024Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 1.5X12MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 18 ATMOSPHERES (ATM) DURING THE SECOND INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. 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 19723776 ↗
• MalfunctionJun 10, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN A 90% STENOSED RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 1.5X12MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY AND THE BALLOON RUPTURED AT 6 ATMOSPHERES (ATM) ONE TIME. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19504827 ↗
• MalfunctionMay 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION. THE 1.5X12MM 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 8 ATMOSPHERES (ATM). IT WAS THOUGHT THAT THE BALLOON MAY HAVE RUPTURED DUE TO THE STRUTS OF A STENT THAT HAD BEEN IMPLANTED IN A PREVIOUS PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER MNI TREK BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19394996 ↗
• MalfunctionApr 4, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS DISTAL LEFT ANTERIOR DESCENDING ARTERY THAT IS 99% STENOSED. THE 1.5X12MM MINI TREK BALLOON DILATATION CATHETER MET RESISTANCE DURING ADVANCEMENT WITH ANATOMY. ONCE AT THE LESION DURING THE FIRST INFLATION THE BALLOON RUPTURED AT 10 ATMOSPHERES. ANOTHER BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS 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 19047762 ↗
• MalfunctionJan 31, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PLAD). A 1.50X12MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS USED TO PRE-DILATE, HOWEVER, DURING THE FIRST INFLATION A RUPTURE OCCURRED AT 6 ATMOSPHERE FOR 5 SECONDS. A 2.0X15MM NEO TREK BALLOON DILATATION CATHETER (BDC) WAS USED AS A REPLACEMENT. HOWEVER, A RUPTURE OCCURRED DURING THE FIRST INFLATION AT 8 ATMOSPHERE FOR 5 SECONDS. THEREFORE, A ROTATIONAL ATHERECTOMY DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO REPORT OF CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619757 ↗
• MalfunctionJan 15, 2024Difficult to Remove; Material Rupture; Difficult to Advance; Difficult to Remove; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 1.5X12MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM); THEREFORE THE BDC WAS REMOVED AND RESISTANCE WAS ALSO NOTED DUE TO THE ANATOMY. A NC TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18515026 ↗
• MalfunctionDec 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH MILD CALCIFICATION AND 90% STENOSIS. THE 1.5X12 MM MINI TREK BALLOON DILATATION CATHETER WAS USED FOR PRE-DILATATION BUT RUPTURED DURING THE FIRST INFLATION TO 8 ATMOPSHERES. A NON ABBOTT 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 18260247 ↗
• MalfunctionNov 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA). THE 1.5X12MM MINI TREK BALLOON DILATATION CATHETER (BDC) RUPTURED DURING THE FIRST INFLATION AT 5 ATMOSPHERES (ATMS) FOR 2 SECONDS. ANOTHER 2.0X15MM MINI TREK BDC WAS INFLATED BUT ALSO RUPTURED. A THIRD 3.0X12MM NC TREK NEO BDC WAS INFLATED BUT RUPTURED AGAIN. A 3.0MM NON- ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE DEVICES WERE ALL PREPARED PER INSTRUCTIONS FOR USE AND THERE WAS NO RESISTANCE WHEN THE PROTECTIVE SHEATH WAS REMOVED. THERE WAS NO RESISTANCE DURING ADVANCEMENT AND REMOVAL. THERE WAS NO ADVERSE PATIENT EFFECT 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 18242927 ↗
• MalfunctionOct 30, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS POSTERIOR LATERAL ARTERY. THE 1.5X12MM MINI TREK BALLOON DILATATION CATHETER FAILED TO CROSS DUE TO ANATOMY. RESISTANCE WAS MET DURING REMOVAL WITH ANATOMY. A DIFFERENT BALLOON WAS USED TO SUCCESSFULLY CROSS. THERE WAS 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 18031103 ↗
• MalfunctionOct 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS AND 100% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE 1.50X12MM NC TREK BALLOON DILATATION CATHETER (BDC), WAS ADVANCED WITHOUT RESISTANCE; HOWEVER, RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS. THE BDC WAS REMOVED WITHOUT RESISTANCE AND ANOTHER NC TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 17981304 ↗