TREK™ 1012274-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 08717648138430), received between Aug 1, 2016 and Jun 3, 2026 — classified as 10 injuries, 97 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (70 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 107 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Material Separation

  IT WAS REPORTED THAT THE 3.0X15MM TREK BALLOON DILATATION CATHETER (BDC) SHAFT SEPARATED (JUST BELOW THE HUB) DURING PREPARATION, PRIOR TO BEING INSERTED IN THE ANATOMY. ANOTHER TREK 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 25377166 ↗
• InjuryMay 21, 2026Material Rupture; Material Separation

  MEDWATCH REPORT #MW5187393. TREK 3.0 X 15 ANGIOPLASTY BALLOON RUPTURED WITH PORTION OF BALLOON RETAINED, INTERVENTION REQUIRED TO MITIGATE PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 25240610 ↗
• MalfunctionMay 12, 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 3.00X15MM TREK RX BALLOON DILATATION CATHETER, RESISTANCE WAS ENCOUNTERED AT THE LESION SITE. ONCE AT THE LESION, THE BALLOON RUPTURED AT 6 ATMOSPHERES DURING THE INITIAL INFLATION. THE TREK BDC WAS WITHDRAWN, AND A NEW TREK BDC WAS USED TO COMPLETE THE PROCEDURE.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 25150685 ↗
• MalfunctionMay 8, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 3X15 MM TREK BALLOON DILATATION CATHETER RUPTURED AT NOMINAL PRESSURE. AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25126051 ↗
• MalfunctionJan 12, 2026Material Rupture; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA. RESISTANCE WAS MET INSERTING THE 3.0X15MM RX TREK BALLOON DILATATION CATHETER (BDC). THE DEVICE WAS ADVANCED TO THE TARGET LESION HOWEVER THE BALLOON RUPTURED DURING THE SECOND INFLATION. DURING REMOVAL THE SHAFT SEPARATED FROM THE BALLOON; THE SEPARATED PORTION WAS STILL ON THE GUIDE WIRE THEREFORE THE ENTIRE SYSTEM WAS WITHDRAWN WITHOUT ISSUE. 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 24039223 ↗
• MalfunctionJan 6, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND HEAVILY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 3.0X15MM RX TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. DURING THE SECOND INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURE OCCURRED. THE BDC WAS REMOVED AND ANOTHER NON-ABBOTT 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 23973375 ↗
• MalfunctionDec 30, 2025Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO THE INITIAL FILED REPORT, IT WAS REPORTED THAT THE TREK RX BDC WAS INFLATED TO 20 ATMOSPHERES FOR 10 SECONDS AND A RUPTURE OCCURRED. THE TREK RX BDC WAS REMOVED, AND THE PROCEDURE WAS CONTINUED USING A 3.0X15MM ABBOTT CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER AND NC TREK BALLOON. A 3.5X18MM XIENCE DRUG-ELUTING STENT WAS IMPLANTED. PATIENT ID: (B)(6). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926358 ↗
• MalfunctionNov 10, 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 AND HEAVY TORTUOSITY. THE 3.0X15 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES AND RUPTURED. ANOTHER 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 23512275 ↗
• MalfunctionNov 3, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MILDLY TORTUOUS MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 3.00X15MM TREK RX BALLOON DILATATION CATHETER, RESISTANCE WAS NOTED WITH THE ANATOMY. ONCE AT THE LESION FOR PRE-DILATION, THE TREK RX BALLOON RUPTURED AT 6 ATMOSPHERES DURING THE FIRST INFLATION. THE TREK RX BDC WAS REMOVED AND 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 23457802 ↗
• MalfunctionNov 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO MILDLY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION WITH 90% STENOSIS. A 3.00 X 15MM TREK BDC WAS PREPPED PRIOR TO USE WITHOUT ISSUES. THE TREK WAS ADVANCED, BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED NC BALLOON, AND A DRUG ELUTING STENT. 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 23457021 ↗
• MalfunctionSep 19, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 3X15MM 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 SECOND INFLATION AT 10 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT 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 23097137 ↗
• MalfunctionAug 25, 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 MID RIGHT CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF A 3.00X15MM TREK RX BALLOON DILATATION CATHETER, RESISTANCE WAS MET DUE TO ANATOMY. ONCE AT THE LESION FOR PRE-DILATATION, THE TREK BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION AND THUS, REMOVED. 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 22889289 ↗
• MalfunctionAug 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN THE 3.0X15MM RX TREK BALLOON DILATATION CATHETER WAS REMOVED FROM THE COIL DISPENSER, THE SHAFT WAS NOTED TO BE SEPARATED. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO 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 22700953 ↗
• MalfunctionMay 27, 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) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 3X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 12 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT 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 22091799 ↗
• MalfunctionApr 29, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MODERATELY TORTUOUS DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF A 3.00X15MM TREK BALLOON, RESISTANCE WAS MET WITH ANATOMY. ONCE AT THE LESION, THE TREK BALLOON WAS INFLATED AND RUPTURED ON THE 2ND INFLATION AT 10 ATMOSPHERES. A NON-ABBOTT 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 21928864 ↗
• MalfunctionApr 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). DURING AN ATTEMPT TO DILATE THE LESION USING A 3.0 X 15 MM TREK RX BALLOON DILATATION CATHETER (BDC), THE BALLOON WAS NOTED TO RUPTURE DURING THE FIRST INFLATION AT 10ATMS. THEREFORE, AN ALTERNATIVE DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858473 ↗
• MalfunctionJan 28, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). AFTER A 3X15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED, PER THE INSTRUCTIONS FOR USE (IFU), WITH NO ISSUES, IT WAS ADVANCED THROUGH RESISTANCE TO THE TARGET LESION. HOWEVER, DURING PRE-DILATATION THE BALLOON WAS NOTED TO RUPTURE DURING THE SECOND INFLATION TO 8 ATMOSPHERES. THE BDC WAS REPLACED WITH A NEW TREK BDC AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21256671 ↗
• MalfunctionJan 7, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. FOR PRE-DILATATION, THE 3X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCE TO THE TARGET LESION WITH RESISTANCE DUE 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 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 21096500 ↗
• MalfunctionDec 27, 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 RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. FOR PRE-DILATION, THE 3X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE TO THE TARGET LESION DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 8 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER 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 21028671 ↗
• MalfunctionAug 27, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE BIFURCATION OF THE LCX AND LAD. THE 3X15MM TREK BALLOON DILATATION (BDC) ADVANCED TO IN THE LAD DISTAL OF THE TARGET LESION, THEN THE 3.5X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION IN THE BIFURCATION; HOWEVER, RESISTANCE WAS FELT AND BLOOD WAS NOTED TO BE COMING TO THE INFLATION DEVICE. IT WAS THEN REALIZED THAT THE SDS WAS ADVANCE INADVERTENTLY ON THE SAME GUIDE WIRE (GW) AS THE BDC AND THE SDS WAS PUSHED INTO THE BDC CAUSING THE BALLOON OF THE BDC TO BECOME TORN. THE TREK BDC AND THE XIENCE SKYPOINT SDS WERE REMOVED INDEPENDENTLY FROM THE PATIENT WITHOUT ISSUE. ANOTHER SAME SIZE TREK BDC AND SAME SIZE XIENCE SKYPOINT SDS WERE 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 20081840 ↗
• InjuryMay 16, 2024Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES " THE PATIENT WAS UNDERGOING PRIMARY CORONARY INTERVENTION FOR AN ACUTE ST ELEVATION MYOCARDIAL INFARCTION (STEMI). A BALLOON CATHETER WAS PASSED ACROSS THE LESION UNEVENTFULLY. WHEN THE BALLOON WAS ATTEMPTED TO BE INFLATED, THERE WAS NO INCREASE IN PRESSURE AND IT WAS DECIDED TO REMOVE THE BALLOON CATHETER. WHEN BALLOON CATHETER WAS BEING REMOVED, ONLY THE DISTAL HALF WAS REMOVED WITH THE PROXIMAL HALF ACROSS THE LESION AND INTO THE GUIDE CATHETER. A SECOND GUIDEWIRE WAS PASSED INTO THE ARTERY AND OVER IT A 3 MM ANGIOPLASTY CATHETER WAS PASSED TO THE DISTAL END OF THE GUIDE CATHETER AND INFLATED, PINNING DOWN THE HALF OF THE FIRST ANGIOPLASTY CATHETER THAT REMAINED IN THE VESSEL. THE GUIDE CATHETER WAS THEN REMOVED ALONG WITH BOTH GUIDE WIRES, THE DISTAL HALF OF THE FIRST BALLOON AND THE SECOND BALLOON CATHETER". IT WAS NOTED THAT THE TREK BALLOON WAS NOT SOAKED PRIOR TO USE AND WHEN ATTEMPTING TO INFLATE IT DID NOT HOLD PRESSURE. ANOTHER UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19335149 ↗
• InjuryMay 13, 2024Inflation Problem; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Inflation Problem; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO INITIAL MDR REPORT, THE MEDWATCH MW5153797 WAS RECEIVED WHICH STATES: THE PATIENT WAS UNDERGOING PRIMARY CORONARY INTERVENTION FOR AN ACUTE ST ELEVATION MYOCARDIAL INFARCTION (STEMI). A BALLOON CATHETER WAS PASSED ACROSS THE LESION UNEVENTFULLY. WHEN THE BALLOON WAS ATTEMPTED TO BE INFLATED, THERE WAS NO INCREASE IN PRESSURE AND IT WAS DECIDED TO REMOVE THE BALLOON CATHETER. WHEN BALLOON CATHETER WAS BEING REMOVED, ONLY THE DISTAL HALF WAS REMOVED WITH THE PROXIMAL HALF ACROSS THE LESION AND INTO THE GUIDE CATHETER. A SECOND GUIDEWIRE WAS PASSED INTO THE ARTERY AND OVER IT A 3 MM ANGIOPLASTY CATHETER WAS PASSED TO THE DISTAL END OF THE GUIDE CATHETER AND INFLATED, PINNING DOWN THE HALF OF THE FIRST ANGIOPLASTY CATHETER THAT REMAINED IN THE VESSEL. THE GUIDE CATHETER WAS THEN REMOVED ALONG WITH BOTH GUIDE WIRES, THE DISTAL HALF OF THE FIRST BALLOON AND THE SECOND BALLOON CATHETER". SUBSEQUENT TO FILING THE INITIAL REPORT, IT HAS BEEN CONFIRMED THAT THIS EVENT IS A DUPLICATE OF (B)(4) WHICH WAS PREVIOUSLY FILED UNDER MFR#2024168-2024-05976, BASED ON THE FOLLOWING INFORMATION THAT MATCHED: PHYSICIAN NAME, HOSPITAL NAME [ALTHOUGH ORIGINALLY DIFFERENT, THE ABBOTT SALES REP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19304355 ↗
• MalfunctionMar 14, 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 DISTAL RIGHT CORONARY ARTERY THAT WAS MILDLY CALCIFIED, MODERATELY TORTUOUS AND 90% STENOSED. A TREK RX 2.5MM WAS USED FOR PRE-DILATATION. THEN IT WAS UPSIZED TO A TREK RX 3.0*15MM AND INFLATED AT 8 ATMOSPHERES. A BALLOON RUPTURE OCCURRED, DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THERE WAS RESISTANCE DURING ADVANCEMENT TO THE LESION. THE DEVICE WAS REPLACED WITH A NON-ABBOTT BALLOON TO DILATE AGAIN. A XIENCE SKYPOINT 2.5*38 MM STENT WAS DEPLOYED AND IVUS CONFIRMED IT WAS WELL APPOSED, SO THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED 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 18907013 ↗
• MalfunctionFeb 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.0X15MM RX TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND INFLATED HOWEVER THE BALLOON RUPTURED AT 10 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THE BDC WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE COMPLETED USING ANOTHER BALLOON. 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 18727174 ↗
• MalfunctionJan 16, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE OBTUSE MARGINAL (OM) CORONARY ARTERY WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 3.0X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED FOR USE PER THE INSTRUCTIONS FOR USE AND ADVANCED FOR PRE-DILATATION. RESISTANCE WAS FELT WITH THE PATIENT ANATOMY DURING ADVANCEMENT. THE BDC RUPTURED AFTER THE FIRST INFLATION TO 8 ATMOSPHERES. THERE WAS NO RESISTANCE DURING REMOVAL OF THE BDC. AN NC TREK 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 18522013 ↗