MINI TREK™ 1012270-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 08717648138164), received between Feb 22, 2017 and Sep 25, 2026 — classified as 2 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (29 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. 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 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Rupture; Improper or Incorrect Procedure or Method

  It was reported the procedure was to treat a mildly tortuous and severely calcified lesion in the mid Left Circumflex artery. The 2.0x20mm RX Mini Trek balloon dilatation catheter was not soaked during the preparation for use. The device was advanced to the target lesion however during inflation, the balloon ruptured due to severe calcification of the lesion. Th procedure was completed using another device. There were no adverse patient effects. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896585 ↗
• MalfunctionFeb 10, 2026Material Separation; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT CIRCUMFLEX CORONARY ARTERY WITH MODERATE CALCIFICATION AND 90% STENOSIS. THE 2X20M MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE ADVANCED BUT THERE WAS RESISTANCE DUE TO THE ANATOMY AND THE SHAFT KINKED. UPON REMOVAL, THE SHAFT SEPARATED ONCE OUTSIDE THE ANATOMY. A NON-ABBOTT DEVICE 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 24309417 ↗
• MalfunctionJan 12, 2026Material Separation; Deformation Due to Compressive Stress

  IT WAS NOTED THAT WHEN REMOVING THE 2.00X20MM MINI TREK BALLOON DILATATION CATHETER (BDC) FROM THE DISPENSER HOOP, THE SHAFT WAS BENT AND SEPARATED. A NEW MINI TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT, AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24046666 ↗
• MalfunctionOct 29, 2025Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  SUBSEQUENT TO THE INITIALLY FILED REPORTS THE DEVICE WAS RECEIVED WITH NO SIGNS OF USE. THE ACCOUNT STATED THAT THE DEVICE WAS NOTED TO BE SEPARATED UPON OPENING AND THE DEVICE WAS NOT USED IN THE ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415553 ↗
• MalfunctionSep 22, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE 2.0X20 MM MINI TREK BALLOON DILATATION CATHETER WAS NOTED TO HAVE ALREADY HAVE A PUNCTURE BEFORE IT WAS INFLATED AT THE LESION FOR PRE-DILATATION. THERE WERE NO REPORTED 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 23108865 ↗
• InjuryJun 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A STENOSED LESION IN THE ANTERIOR INTERVENTRICULAR ARTERY. THE 2.0 X 20 MM RX MINI TREK BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION; HOWEVER, DURING THE FIRST INFLATION IT WAS NOTED THE BALLOON WAS LEAKING CONTRAST AND SMALL AIR BUBBLES WERE NOTED IN THE CIRCUMFLEX ARTERY. THE PATIENT EXPERIENCED CHEST PAIN, CHANGE IN ECG, AND DESATURATION. A GUIDE WAS ADVANCED AND CONTRAST WAS INJECTED IN THE CIRCUMFLEX TO REMOVE THE AIR BUBBLES. ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Air Embolism; Angina; Hypoxia; Non specific EKG/ECG Changes

  MAUDE report 22232320 ↗
• MalfunctionJun 12, 2025Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE OF A 2.00X20MM MINI TREK RX BALLOON DILATATION CATHETER, THE SHAFT WAS OBSERVED TO BE KINKED IN 3 PLACES. A NEW UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURN DEVICE ANALYSIS IDENTIFIED THAT THE STYLET AND PROTECTIVE SHEATH COULD NOT BE REMOVED FROM THE BDC. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196017 ↗
• MalfunctionApr 8, 2025Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AFTER PREPARATION THE 2X20MM MINI TREK BALLOON DILATATION CATHETER (BDC) BECAME HUB SEPARATED WHEN REMOVING THE BDC FROM THE DISPENSER HOOP. THEREFORE, THE BDC WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21800926 ↗
• MalfunctionFeb 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MILDLY CALCIFIED, MILDLY TORTUOUS PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY THAT IS 90% STENOSED. A 2.00X20MM MINI TREK BALLOON DILATATION CATHETER WAS USED FOR PREDILATATION AND RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. ROTA AND ANOTHER TREK BALLOON WERE 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 21358663 ↗
• MalfunctionDec 9, 2024Material 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 2.0X20MM 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. 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 20879239 ↗
• MalfunctionDec 6, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. THE 2X20MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, A RUPTURED OCCURRED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER TREK BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE ARE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20867231 ↗
• MalfunctionNov 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH MILD CALCIFICATION AND MILD TORTUOSITY. FOR PRE-DILATION THE 2X20MM MINI TREK BALLOON DILATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE BALLOON RUPTURED AFTER 5 SECONDS AT 8 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ROTABLATION AND ADDITIONAL BALLOONING WAS USED TO COMPLETE 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 20800677 ↗
• MalfunctionNov 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 95% STENOSED LESION IN THE DISTAL LEFT CIRCUMFLEX ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 2X20MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED ONCE TO 14 ATMOSPHERES (ATM). HOWEVER, THE BALLOON RUPTURED; THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20616248 ↗
• MalfunctionOct 30, 2024Material Rupture; Material Rupture

  SUBSEQUENT TO THE INITIALLY FILED REPORTS IT WAS NOTED THAT THE NC TREK NEO BALLOON WAS INFLATED ONCE TO 10 ATMOSPHERES AND THEN RUPTURED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569516 ↗
• MalfunctionOct 17, 2024Deflation Problem; Improper or Incorrect Procedure or Method; Deflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TOTAL OCCLUSION IN THE OSTIAL/PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 2.0X20 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE TO 10 ATMOSPHERES BUT ONLY PARTIALLY DEFLATED. NEGATIVE PRESSURE WAS HELD SEVERAL TIMES FOR AT LEAST 30 SECONDS. ASPIRATION WAS PERFORMED WITH A NEW MANOMETER AND SYRINGE BUT THE BALLOON STILL WOULD NOT DEFLATE. THE BALLOON WAS REMOVED INFLATED INTO THE GUIDE CATHETER AND REMOVED FROM THE PATIENT. THE CONTRAST WAS NOT DILUTED 1:1 WITH SALINE. 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 20472713 ↗
• MalfunctionSep 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS DISTAL RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THE 2.0X20MM MINI TREK BALLOON DILATATION RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. ROTABLATION WAS PERFORMED AND A NEW 2.0X15MM TREK WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226271 ↗
• MalfunctionAug 28, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT CIRCUMFLEX CORONARY ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 2.0×20MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS PREPPED PER INSTRUCTIONS FOR USE. THE BALLOON WAS ADVANCED FOR PRE-DILATION WITH NO RESISTANCE. THE BALLOON WAS INFLATED ONCE TO 8 ATMOSPHERES AND HELD FOR 5 SECONDS WHEN A RUPTURE OCCURRED. THEREFORE, ROTATIONAL ATHERECTOMY (ROTA) WAS PERFORMED AND A NEW 2.0X15MM NC TREK NEO BDC 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 20089729 ↗
• MalfunctionJun 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). DURING THE FIRST INFLATION OF THE 2.0X20MM RX MINI TREK FOR PRE-DILATION THE BALLOON RUPTURED IN 5 SECONDS AT 6 ATMOSPHERES. A ROTATIONAL ATHERECTOMY (ROTA) WAS PERFORMED AND A NEW TREK DEVICE 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 19582833 ↗
• MalfunctionMay 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 2.0X20MM RX MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED TO 8 ATMOSPHERES HOWEVER THE BALLOON RUPTURED. THE BDC WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE COMPLETED USING ANOTHER SAME SIZE MINI TREK. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19377005 ↗
• MalfunctionApr 11, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HIGHLY CALCIFIED OSTIUM OF THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 1.2X15 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE NOTED WITH THE ANATOMY AND A PREVIOUSLY IMPLANTED STENT. THE BALLOON WAS INFLATED 6 TIMES UP TO 14 ATMOSPHERES (ATM) IN THE PROXIMAL AND MIDDLE PORTIONS OF THE LESION BUT RUPTURED AT 8 ATM IN THE OSTIUM. NEXT, THE 2.5X20 MM TREK BDC WAS ADVANCED WITH RESISTANCE NOTED WITH THE SEVERE CALCIUM AND A PREVIOUSLY IMPLANTED STENT. THE BALLOON WAS INFLATED 3 TIMES UP TO 14 ATM IN THE PROXIMAL AND MIDDLE PORTIONS BUT RUPTURED AT 8 ATM IN THE OSTIUM. THE 2.0X20 MM MINI TREK BDC WAS ADVANCED WITH RESISTANCE NOTED WITH THE ANATOMY AND A PREVIOUSLY IMPLANTED STENT AND WAS INFLATED ONCE IN THE PROXIMAL/MIDDLE OF THE LESION. WHEN ATTEMPTING TO INFLATE IN THE OSTIUM, THE BALLOON RUPTURED AT 8 ATM. THE 3.0X20 MM TREK BDC WAS ADVANCED WITH RESISTANCE NOTED WITH THE LESION AND A PREVIOUSLY IMPLANTED STENT AND WAS INFLATED TWICE IN THE MIDDLE AND PROXIMAL PORTION UP TO 20 ATM WITHOUT ISSUE. WHEN INFLATED THE THIRD TIME IN THE OSTIUM, THE BALLOON RUPTURED AT 9 ATM. FINALLY, THE 3.0X20 MM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19092878 ↗
• MalfunctionDec 27, 2023Difficult 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 LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY THAT WAS MODERATELY CALCIFIED, HEAVILY TORTUOUS AND 90% STENOSED. THE 2.00 X 20 MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED. THERE WAS RESISTANCE WAS MET WITH THE LESION DURING ADVANCEMENT. THE BALLOON WAS INFLATED, BUT A RUPTURE OCCURRED AT 8 ATMOSPHERES DURING THE 1ST INFLATION. THE BDC WAS REMOVED AND RESISTANCE WAS MET WITH THE LESION DURING REMOVAL. A NEW NC TREK NEO 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 18401397 ↗
• MalfunctionDec 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE 90% STENOSED, MILDLY CALCIFIED AND MILDLY TORTUOUS DISTAL RIGHT CORONARY ARTERY (DRCA). THE BALLOON OF A 2.0X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS INFLATED FOR 5 SECONDS. DURING THE FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. A 2.00 X 12MM MINI TREK BDC WAS ADVANCED AND THE BALLOON INFLATED FOR 4 SECONDS TO 5 ATMOSPHERES; HOWEVER, ALSO RUPTURED. LASTLY A 2.0X20MM MINI TREK BDC WAS ADVANCED AND THE BALLOON INFLATED FOR 4 SECONDS, THE BALLOON RUPTURED AT 5 ATMOSPHERES ON THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH A SAPPHIRE BDC WITHOUT REPORTED ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18269053 ↗
• MalfunctionNov 21, 2023Difficult 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 CIRCUMFLEX ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 2.0X20MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE. WHEN THE BALLOON WAS INFLATED TO 6 ATMOSPHERES A LEAK OF CONTRAST WAS NOTED, CONFIRMING A RUPTURE. THE BDC WAS REMOVED FROM THE PATIENT AND RESISTANCE WAS ALSO NOTED WITH THE LESION. A NEW TREK BALLOON WAS USED TO COMPLETE 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 18185695 ↗
• MalfunctionNov 17, 2023Break; Stretched; Difficult to Advance; Break; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT CALCIFIED LESIONS IN THE MIDDLE AND DISTAL THIRD RIGHT CORONARY ARTERY (RCA). THE HI-TORQUE 014 BMW GUIDEWIRE (GW) WAS USED IN THE PROCEDURE; HOWEVER, THE GW WOULD NOT ALLOW THE ADVANCEMENT OF A 2.0 MINI TREK BALLOON DILATATION CATHETER (BDC) AND A 3.25X20MM NC TREK BDC. WHEN ATTEMPTING TO ADVANCE EACH BDC, RESISTANCE WAS MET WITH THE GW AND THE SHAFT BECAME STRETCHED AND BROKE ON EACH BDC. THE GW WAS EXCHANGED FOR A HI-TORQUE 014 BHW GW, WHICH WAS ALSO NOTED TO HAVE DIFFICULTY WHEN ADVANCING OTHER DEVICES. TWO DRUG-ELUTING STENTS WERE IMPLANTED TO COMPLETE 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 18164098 ↗
• MalfunctionNov 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT WHEN THE 2.0X20MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS CONNECTED TO THE INDEFLATOR, A LEAK IN THE BALLOON WAS DETECTED AS THE PRESSURE DECREASED IMMEDIATELY AFTER ATTEMPTING TO INFLATE. SEVERAL ATTEMPTS WERE MADE, BUT UNSUCCESSFUL. 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 18132816 ↗