TREK™ 1012271-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 08717648138225), received between Nov 2, 2016 and May 19, 2026 — classified as 1 injury, 49 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (40 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE 2.25X15 MM TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE WITHOUT INCIDENT. THE BDC MET RESISTANCE WITH THE MILDLY TORTUOUS, MODERATELY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY, WHEN IT WAS ADVANCED TO THE TARGET FOR PREDILATATION. THE BDC RUPTURED AT 6 ATMOSPHERES DURING ITS FIRST INFLATION. THE BDC WAS REMOVED. A 2.0X15 MM MINI TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT ADVERSE EVENTS, AND NO CLINICALLY SIGNIFICANT PROCEDURAL DELAYS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25217734 ↗
• MalfunctionMay 12, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. FOR PRE-DILATATION, THE 2.25X15M TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCE 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, AND 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 25149918 ↗
• MalfunctionDec 9, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MILDLY CALCIFIED, MILDLY TORTUOUS RIGHT CORONARY ARTERY THAT IS 90% STENOSED. AN INTRAVASCULAR ULTRASOUND CATHETER FAILED TO CROSS SO PRE-DILATATION WAS TO BE PERFORMED. DURING ADVANCEMENT OF THE 2.25X15 TREK RX BALLOON DILATATION CATHETER (BDC), SLIGHT RESISTANCE WAS NOTED DUE TO ANATOMY. ONCE AT THE LESION FOR PRE-DILATATION, THE TREK RX BDC RUPTURED AT 9 ATMOSPHERES DURING THE SECOND INFLATION. AN UNSPECIFIED BALLOON AND UNSPECIFIED DRUG COATED BALLOON WERE 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 23761375 ↗
• MalfunctionDec 8, 2025Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 2.25X15MM RX TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED INTO THE GUIDING CATHETER HOWEVER RESISTANCE WAS MET AND THE SHAFT SEPARATED. THE SEPARATED SHAFT WAS REMOVED WITHIN THE GUIDING CATHETER. THE PROCEDURE WAS CONTINUED WITH ANOTHER SAME SIZE TREK DEVICE. 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 23746508 ↗
• MalfunctionNov 19, 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, HEAVILY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 75% STENOSED. DURING ADVANCEMENT OF THE 2.25X15MM TREK RX BALLOON DILATATION CATHETER, SLIGHT RESISTANCE WAS FELT DUE TO ANATOMY. THE TREK BALLOON WAS INFLATED AT 8 ATMOSPHERES: HOWEVER RUPTURED AT 12 ATMOSPHERES DURING THE SECOND INFLATION. A 2.0X10MM NON-ABBOT WAS USED TO SUCCESSFULLY DILATE THE LESION. 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 23599252 ↗
• MalfunctionNov 19, 2025Deflation Problem; Failure to Deflate; Deflation Problem; Failure to Deflate

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE 2.25X15MM TREK RX BALLOON DILATATION CATHETER (BDC) COMPLETELY FAILED TO DEFLATE INSIDE THE PATIENT'S ANATOMY. THE INFLATION DEVICE WAS REPLACED; HOWEVER, THE BALLOON WOULD STILL NOT DEFLATE. IT IS UNKNOWN IF THE BALLOON WAS DEFLATED WHEN REMOVED. AN UNSPECIFIED BALLOON WAS USED TO 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 23597973 ↗
• MalfunctionJul 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD). THE 2.25X15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED AND ADVANCED WITH NO NOTED ISSUES, AND ATTEMPTED TO BE USED FOR VESSEL DILATATION; HOWEVER, DURING THE FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 8ATMS. THEREFORE THE BDC WAS REMOVED AND A NC 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 22580727 ↗
• MalfunctionMar 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.25X15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED AND ADVANCED TO THE LESION WITH NO NOTED ISSUES; HOWEVER, DURING THE SECOND INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 11ATM. THE BDC WAS REMOVED AND AN ALTERNATIVE BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619329 ↗
• MalfunctionFeb 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 2.25X15MM TREK BALLOON DILATATION CATHETER (BDC) RUPTURED DURING THE SECOND INFLATION AT 8 ATMOSPHERES (ATM). 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 21364033 ↗
• MalfunctionFeb 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE DISTAL RIGHT CORONARY ARTERY. THE 2.25X15MM RX TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATATION; HOWEVER THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 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 21321233 ↗
• MalfunctionOct 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS LESION IN THE DISTAL RIGHT CORONARY ARTERY. THE 2.25X15MM RX TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED HOWEVER THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THE BDC WAS REMOVED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED USING NON-ABBOTT DEVICES. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344795 ↗
• MalfunctionJul 23, 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 THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. THE 2.25X15MM RX TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE BALLOON WAS INFLATED HOWEVER IT RUPTURED DURING THE SECOND INFLATION AT 16 ATMOSPHERS. THE BDC WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. 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 19804697 ↗
• MalfunctionApr 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (DLAD) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 2.25X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR PRE-DILATATION; HOWEVER, THE BALLOON RUPTURED AT 12 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WAS 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 19025867 ↗
• MalfunctionSep 25, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS LEFT CIRCUMFLEX ARTERY. THE 2.25X15MM TREK BALLOON DILATATION CATHETER (BDC) MET RESISTANCE DURING ADVANCEMENT WITH THE ANATOMY AND ONCE AT THE LESION DURING THE FIRST INFLATION THE BDC RUPTURED AT 8 ATMOSPHERES FOR 3 SECONDS. A NON COMPLAINT 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 17814261 ↗
• MalfunctionJul 26, 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 90% STENOSED DISTAL RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 2.25X15MM 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 10 ATMOSPHERES. THEREFORE, THE BDC WAS REMOVED FROM THE ANATOMY AND RESISTANCE WAS ALSO NOTED DUE TO ANATOMY. PRIOR TO USE, THE BALLOON WAS SOAKED IN SALINE AND THE BDC WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY. A NEW TREK BDC 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 17401769 ↗
• MalfunctionJun 16, 2023Material 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. THE 2.00X15MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND RESISTANCE WAS NOTED DUE TO THE ANATOMY. DURING THE SECOND INFLATION, THE BALLOON RUPTURED AT 12 ATMOSPHERES (ATM). THE BDC WAS REMOVED AND THE 2.25X15MM TREK BDC WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE WAS NOTED DUE TO THE ANATOMY. DURING THE FIRST INFLATION, THE BALLOON ALSO RUPTURED AT 12 ATM AND WAS REMOVED FROM THE ANATOMY. A NON-ABBOTT 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 17144278 ↗
• MalfunctionMay 5, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A FISTULA IN THE POSTERIOR LATERAL ARTERY WITH 99% STENOSIS, HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 1.2X12MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR PRE-DILATATION AND HAD RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT. THE BALLOON WAS INFLATED ONCE AT ABOUT 4 ATMOSPHERES (ATMS) AND RUPTURED. THERE WAS NO RESISTANCE DURING REMOVAL. ANOTHER BALLOON WAS USED TO COMPLETE THE PRE-DILATATION. AFTER PRE-DILATATION, THE BALLOON WAS UPSIZED USING A 2.25X15MM TREK RX BALLOON AND RESISTANCE WITH THE ANATOMY WAS ALSO NOTED DURING ADVANCEMENT. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT ABOUT 5 ATMS. THERE WAS NO RESISTANCE DURING REMOVAL. PRIOR TO USE, THE CATHETERS WERE SOAKED IN SALINE AND PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY. ANOTHER NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 16881570 ↗
• MalfunctionApr 26, 2023Material 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 THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 2.25X15 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED WITH THE ANATOMY AND DURING THE FIRST INFLATION TO 10 ATMOSPHERES, THE BALLOON RUPTURED. PRIOR TO USE THE DEVICE WAS NOT SOAKED IN SALINE. A NON-ABBOTT 2.0X9 MM 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 16816397 ↗
• MalfunctionMar 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED DE NOVO LESION IN THE DISTAL LEFT CIRCUMFLEX (DLCX) ARTERY. PRIOR TO USE THE 2.25X15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS SOAKED IN SALINE AND THE BDC WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY. THERE WAS NO RESISTANCE NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE BDC WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, A RUPTURE OCCURRED DURING THE FIRST INFLATION AT 8 ATMOSPHERES (ATM). 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 CONTINUE PRE-DILATATION, FOLLOWED BY STENT IMPLANTATION AND POST DILATATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645365 ↗
• MalfunctionMar 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED, DE NOVO LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (DLAD) ARTERY. A 2.25X15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED TWICE TO 8 ATMOSPHERES (ATM), WHEN THE BALLOON RUPTURED. THE BDC WAS REMOVED WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. A NON-ABBOTT BALLOON WAS USED AND A STENT IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587437 ↗
• MalfunctionMar 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH 75% STENOSIS. THE 2.25X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS SOAKED IN SALINE AND WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO RESISTANCE WHEN THE PROTECTIVE SHEATH WAS REMOVED AND THERE WAS NO RESISTANCE DURING ADVANCEMENT. HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES (ATMS). THERE WAS NO RESISTANCE DURING REMOVAL. ANOTHER NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED 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 16486416 ↗
• MalfunctionDec 7, 2022Difficult to Remove; Material Rupture; Difficult to Advance; Difficult to Remove; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION, HEAVY TORTUOSITY AND 90% STENOSIS. THE 2.25X15 MM TREK BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION WITH RESISTANCE WITH THE ANATOMY NOTED. THE BDC WAS INFLATED TO AROUND 4 ATMOSPHERES WHEN A LEAK OF CONTRAST OCCURRED, INDICATING A RUPTURE. THE BDC WAS REMOVED WITH RESISTANCE NOTED WITH THE LESION AND A CUTTING 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 15934562 ↗
• MalfunctionOct 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED DE NOVO RIGHT POSTERIOR DESCENDING ARTERY (RPDA) THAT IS 75% STENOSED. A 2.25X15MM TREK BALLOON DILATATION CATHETER RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES. A NON-ABBOTT 2.25X15MM BALLOON WAS USED TO PRE-DILATE THE LESION AND A NON-ABBOTT 2.5X16MM WAS DEPLOYED. IN ADDITION, A 2.5X15MM NON-ABBOTT BALLOON WAS USED TO POST DILATE TO FULLY 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 15625813 ↗
• MalfunctionJul 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. AN UNSPECIFIED GUIDE WIRE CROSSED THE LESION AND INTRA VASCULAR ULTRA SOUND (IVUS) WAS ATTEMPTED TO BE PERFORMED; HOWEVER, FAILED TO CROSS. A 2.25X15MM TREK BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION AND INFLATED, BUT RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089219 ↗
• MalfunctionJun 30, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT POSTERIOR ATRIO-VENTRICULAR ARTERY (RPAV) WITH MILD CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 2.25X15 MM TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR PRE-DILATATION; HOWEVER, THE BALLOON RUPTURED ON THE FIRST INFLATION TO 10 ATMOSPHERES FOR 2 SECONDS. CALCIFICATION WAS NOT NOTED ON IVUS. A NON-ABBOTT 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 14875359 ↗