NC TREK NEO™ 1400300-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 08717648232527), received between Jan 16, 2023 and Apr 13, 2026 — classified as 2 injuries, 33 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 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.

• MalfunctionApr 13, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 3.0X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED. DURING THE FIRST INFLATION AT 6 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 24860861 ↗
• MalfunctionDec 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 3X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE; HOWEVER, THE BALLOON RUPTURED DURING THE INITIAL INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER UNSPECIFIED NON-COMPLIANT 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 23774892 ↗
• MalfunctionNov 10, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE 3.00X15MM NC TREK NEO BALLOON DILATATION CATHETER WAS INFLATED BUT SALINE SOLUTION WAS LEAKING FROM THE SIDE OF THE CATHETER AND THE BALLOON RUPTURED. 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 23512615 ↗
• MalfunctionOct 23, 2025Material 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 MODERATE CALCIFICATION AND MODERATE TORTUOSITY. FOR PRE-DILATATION, THE 3X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, DURING THE INITIAL INFLATION THE BALLOON RUPTURED AT 10 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 N THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23375630 ↗
• MalfunctionOct 6, 2025Difficult to Insert; Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; Difficult to Insert; Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 70% STENOSED. A 3.00X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS LOADED ONTO A 0.014" NON-ABBOTT GUIDEWIRE, WITH DIFFICULTY. RESISTANCE WAS NOTED WHEN ADVANCING THE NC TREK NEO BDC OVER THE GUIDEWIRE AND THE SHAFT WAS OBSERVED TO KINK OUTSIDE THE PATIENT. DIFFICULTY WAS NOTED WHEN REMOVING THE NC TREK NEO BALLOON AND BOTH BALLOON AND GUIDEWIRE WERE REMOVED AS ONE UNIT. AN UNSPECIFIED 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 23223883 ↗
• InjurySep 11, 2025Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO THE FILED REPORTS IT WAS NOTED THAT THE ONLY THREE BALLOONS WERE USED 2.0X20MM TREK, 3.0X12MM NC TREK NEO AND A 3.0X15MM NC TREK NEO BALLOON CATHETERS AND WERE NOT SOAKED PRIOR TO USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23027701 ↗
• MalfunctionJul 7, 2025Material 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 90% STENOSED. THE 3.0X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER, RESISTANCE WAS FELT WITH ANATOMY. ONCE AT THE LESION THE BDC WAS INFLATED TO 15 ATMOSPHERES AND RUPTURED DURING THE FIRST INFLATION. AN UNSPECIFIED DEVICE 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 22421547 ↗
• MalfunctionJul 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 3X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED TO 15 ATMOSPHERES (ATM) FOR 10 SECONDS; HOWEVER, THE BALLOON RUPTURED DURING THE INITIAL INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER UNSPECIFIED DEVICE 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 22368731 ↗
• MalfunctionJun 12, 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 LEFT CIRCUMFLEX (CX). THE 3.0X15 NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES AND ADVANCED TO THE LESION WITH RESISTANCE. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON; HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 8ATMS. THE BDC WAS REPLACED WITH A NEW NC TREK NEO BDC AND THE PROCEDURE WAS CONTINUED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22198349 ↗
• MalfunctionMay 27, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT CIRCUMFLEX (LCX) ARTERY WITH MODERATE CALCIFICATION AND HEAVY TORTUOSITY. THE 3X15MM NC TREK NEO 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 FIRST INFLATION AT 6 ATMOSPHERES (ATM); THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER NC TREK NEO 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 22087551 ↗
• InjuryMay 13, 2025Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  SUBSEQUENTLY TO THE INITIALLY FILED REPORT, IT WAS NOTED THAT THE UNSPECIFIED NC TREK NEO WAS A 2.0X15MM NC TREK NEO BDC. THE KISSING BALLOON TECHNIQUE WAS NOT ATTEMPTED AGAIN AND THE 2.0X15MM NC TREK BDC WAS INFLATED IN THE DIAGONAL BRANCH. THE 3.0X15MM NC TREK NEO WAS USED FOR RE-PROXIMAL OPTIMIZATION TECHNIQUE (RE-POT). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22012047 ↗
• MalfunctionMar 17, 2025Material Separation; Material Separation

  IT WAS REPORTED DURING THE PROCEDURE PREPARATION THAT THE HUB OF A 3X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC), WAS NOTED TO BE SEPARATED WHEN THE BDC WAS REMOVED FROM THE DISPENSER HOOP. THE BDC WAS REPLACED WITH ANOTHER BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619184 ↗
• MalfunctionFeb 12, 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 REPORT, IT WAS REPORTED THE STENT WAS A XIENCE SKYPOINT STENT DELIVERY SYSTEM. THE STENT WAS UNDEPLOYED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21368027 ↗
• MalfunctionJan 22, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 99% STENOSIS. THE 3.0X15 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND RESISTANCE WITH NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED TO 8 ATMOSPHERES AND RUPTURED DURING THE SECOND INFLATION. A NEW NC TREK BDC 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 21212139 ↗
• MalfunctionJan 8, 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 LEFT ANTERIOR DESCENDING ARTERY. THE 3.0X15MM RX NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR POST DILATATION WITH RESISTANCE NOTED DUE TO THE IMPLANTED STENT. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 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 21102299 ↗
• MalfunctionJan 3, 2025Inflation Problem; Material Rupture; Difficult to Advance; Inflation Problem; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 75% STENOSIS. PRE-DILATATION WAS PERFORMED AND AND AN ATTEMPT WAS MADE TO DEPLOY AN UNSPECIFIED STENT. THE 3.0X15 MM NC TREK NEO BALLOON DILATATION CATHETER DID NOT CROSS DUE TO RESISTANCE WITH THE ANATOMY. THE SAME NC TREK BALLOON WAS ADVANCED AGAIN BUT DURING USE THE BALLOON WOULD NOT INFLATE AND IT WAS SUSPECTED TO BE RUPTURED. A NON-ABBOTT BALLOON WAS USED TO COMPLETE 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 21068553 ↗
• MalfunctionDec 27, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THE 3.0X15MM NC TREK NEO BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET SITE WITH RESISTANCE FELT WITH ANATOMY. DURING THE SECOND INFLATION THE BALLOON RUPTURED AT 8 ATMOSPHERES. ANOTHER NC TREK BALLOON WAS USED TO SUCCESSFULLY 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 21028652 ↗
• MalfunctionDec 9, 2024Material 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 3.0X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 8 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 20879187 ↗
• MalfunctionDec 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS AND 90% STENOSED PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH THE 2.75X15MM TREK BALLOON DILATATION CATHETER (BDC) WHICH WAS PREPARED PER INSTRUCTIONS FOR USE. THE BDC WAS ADVANCED AND THE BALLOON WAS INFLATED ONCE TO 8 ATMOSPHERES WHEN A RUPTURE OCCURRED AFTER 5 SECONDS. THEREFORE, BALLOON ANGIOPLASTY WAS ATTEMPTED WITH A 3.00X15MM NC TREK NEO BDC; HOWEVER, WHEN THE BALLOON WAS INFLATED ONCE TO 10 ATMOSPHERES, A RUPTURE OCCURRED AFTER 5 SECONDS. ADDITIONAL DILATATION WAS PERFORMED WITH A NON-ABBOTT ROTABLATION DEVICE AND ANOTHER NC TREK 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 20836444 ↗
• MalfunctionJul 8, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION, HEAVY TORTUOSITY AND 90% STENOSIS. THE 3.0X15 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE WITH THE ANATOMY NOTED. THE BALLOON RUPTURED AT 8 ATMOSPHERES. A NON-ABBOTT BALLOON WAS USED TO COMPLETE 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 19691473 ↗
• MalfunctionJun 10, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. FOR POST DILATATION, THE 3X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCE TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY AND THE BALLOON WAS INFLATED; HOWEVER, A RUPTURE OCCURRED AT 12 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. 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 USE TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505109 ↗
• MalfunctionJun 5, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH MODERATE CALCIFICATION AND TORTUOSITY AND 80% STENOSIS. AFTER A 3.0MM XIENCE STENT WAS DEPLOYED, THE 3.0X15 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED WITH THE ANATOMY. THE BALLOON WAS USED FOR POST-DILATATION, BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 12 ATMOSPHERES. A NON-ABBOTT BALLOON WAS INFLATED AT 14 ATM TO COMPLETE 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 19468903 ↗
• MalfunctionMar 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL RIGHT CORONARY ARTERY WITH MILD CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 3.0X15 MM NC TREK NEO BALLOON DILATATION CATHETER WAS ADVANCED WITHOUT RESISTANCE AND INFLATED TO 6 ATMOSPHERES FOR PRE-DILATATION; HOWEVER, THE BALLOON RUPTURED AFTER 5 SECONDS. THEREFORE, ROTABLATION WAS PERFORMED AND A NEW SAME 3.0X12 MM NC TREK BDC WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. 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 18975312 ↗
• MalfunctionMar 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY TO THE MID LEFT ANTERIOR DESCENDING ARTERY (MLAD) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 3X15 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR POST-DILATATION; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT LESS THAN 10 ATMOSPHERES (ATM). THEREFORE, BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECT 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 18891191 ↗
• MalfunctionFeb 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MODERATELY TORTUOUS, MID LEFT ANTERIOR DESCENDING ARTERY LESION. A 3.0X15MM NC TREK NEO BALLOON DILATATION CATHETER WAS USED FOR POST-DILATATION, HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 12 ATMOSPHERES. 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 18726987 ↗