TREK™ 1012276-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 08717648138577), received between Aug 25, 2016 and Mar 12, 2026 — classified as 9 injuries, 43 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Deflation Problem; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MID TO DISTAL RIGHT CORONARY ARTERY (RCA) LESION. THE 3.50X15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS NOT PREPPED OUTSIDE THE ANATOMY PRIOR TO USE. THE TREK WAS ADVANCED AND INFLATED WITH NO ISSUES; HOWEVER, THE BALLOON ONLY PARTIALLY DEFLATED. UPON REMOVAL OF THE PARTIALLY DEFLATED BALLOON, THE WHOLE BALLOON WAS NOTED TO BE MISSING. ANGIOGRAPHY WAS PERFORMED AND IT WAS CONFIRMED THAT THE BALLOON WAS NOT IN THE ANATOMY. IT WAS NOTED THAT THE BALLOON MAY HAVE COME OFF ON THE TABLE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581604 ↗
• MalfunctionFeb 27, 2026Leak/Splash

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE PROXIMAL TO MID RIGHT CORONARY ARTERY. THE 3.50X15MM RX TREK BALLOON DILATATION CATHETER WAS NOTED TO BE LEAKING AT THE CONNECTION TO THE INDEFLATOR. A NEW RX TREK 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 24469238 ↗
• MalfunctionFeb 18, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, MODERATE CALCIFICATION, MILD TORTUOSITY LEFT ANTERIOR DESCENDING LESION WITH 90% STENOSIS. A 3.50X15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED FOR USE WITHOUT ISSUE. THE BDC WAS ADVANCED AND SLIGHT RESISTANCE WAS FELT WHILE CROSSING THE TARGET LESION. DURING THE FIRST INFLATION AT 8 ATM, THE BALLOON RUPTURED. AN ADDITIONAL 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 24379277 ↗
• MalfunctionNov 26, 2025Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED HEAVILY TORTUOUS LEFT CIRCUMFLEX ARTERY. THE 3.5X15MM TREK BALLOON DILATATION CATHETER WAS NOT SOAKED PRIOR TO USE AND DURING THE FIRST INFLATION THE BALLOON WAS INFLATED TO NOMINAL PRESSURE; HOWEVER, WAS NOT HOLDING PRESSURE. A NEW 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 23662507 ↗
• MalfunctionOct 30, 2025Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. THE 3.5X15MM TREK BALLOON DILATATION CATHETER SHAFT BROKE WHEN ATTEMPTING TO BE ADVANCE. THE TREK WAS REMOVED WITHOUT ISSUE. 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 23430121 ↗
• MalfunctionOct 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE BALLOON OF A 3.50X15MM TREK RX BALLOON DILATATION CATHETER, RUPTURED AT 11 ATMOSPHERES DURING THE SECOND INFLATION. A NEW 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 23361348 ↗
• MalfunctionAug 15, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MILDLY TORTUOUS LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD)WITH 75% STENOSIS. A 3.50 X 15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE, WITH NO ISSUES. INITIALLY, A ZINRAI 2.5/15 MM BALLOON WAS SUCCESSFULLY DELIVERED TO THE LESION FOR PRE-DILATION. TO ACHIEVE FURTHER INDENTATION, THE BDC WAS THEN DELIVERED TO THE LESION, WITH SLIGHT RESISTANCE FELT WITH THE PATIENT ANATOMY. THE FIRST INFLATION AT 8 ATMOSPHERES (ATM) WAS UNEVENTFUL, BUT DURING THE SECOND INFLATION AT 10 ATM, THE BALLOON RUPTURED. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED WITH A HIRYU 3.5/10 MM BALLOON. 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 22819945 ↗
• MalfunctionJul 2, 2025Deflation Problem; Material Separation; Deformation Due to Compressive Stress; Material Twisted/Bent; Material Too Soft/Flexible; Deflation Problem; Material Separation; Deformation Due to Compressive Stress; Material Twisted/Bent; Material Too Soft/Flexible

  SUBSEQUENT TO THE INITIALLY FILED REPORT, IT WAS REPORTED THAT THE BALLOON WAS FULLY DEFLATED WHEN ATTEMPTING TO RE-POSITION, AND THE BALLOON HAD A SLIGHT BEND IN THE CATHETER AND SEPARATED AFTER THE SECOND INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383105 ↗
• MalfunctionJun 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 75% STENOSIS. THE 3.5X15 MM TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED TWICE TO 10 ATMOSPHERES AND RUPTURED. A NON-ABBOTT 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 22152908 ↗
• MalfunctionJun 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND HEAVILY TORTUOUS LESION IN THE PROXIMAL LEFT CIRCUMFLEX. A 3.5X15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE USED FOR DILATATION; HOWEVER, THE BALLOON WAS NOTED TO RUPTURE AT 10ATMS. THEREFORE, THE BDC WAS REMOVED AND AN OPSTAR IMAGING CATHETER WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142609 ↗
• MalfunctionApr 21, 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 MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 3.5X15 MM TREK BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED WITH THE ANATOMY AND THE BALLOON WAS INFLATED ONCE TO 8 ATMOSPHERES AND RUPTURED. A NON-ABBOTT DEVICE 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 21877123 ↗
• MalfunctionFeb 13, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). AFTER THE LESION WAS CROSSED WITH A NON-ABBOTT GUIDEWIRE, A 2.25X15MM NON-ABBOTT BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE USED FOR VESSEL DILATATION, BUT A PINHOLE ON THE BALLOON WAS NOTED. THE BDC WAS REMOVED AND A 3.5X15MM TREK RX BDC WAS ADVANCED TO THE LESION THROUGH RESISTANCE; HOWEVER, DURING THE SECOND INFLATION AT 6ATM ANOTHER PINHOLE RUPTURE WAS NOTED. THE BDC WAS REPLACED WITH ANOTHER UNKNOWN DEVICE 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 21379770 ↗
• MalfunctionDec 13, 2024Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Advance; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.5X15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED INTO THE ANATOMY THROUGH RESISTANCE; HOWEVER, A KINK WAS NOTED AND THE DEVICE WAS REMOVED. THE BDC WAS ATTEMPTED TO BE REINSERTED INTO THE ANATOMY, HOWEVER, THE SHAFT WAS NOTED TO SEPARATE DURING ADVANCEMENT BEFORE ENTERING THE ANATOMY. A NEW BALLOON CATHETER WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20930268 ↗
• MalfunctionNov 6, 2024Improper or Incorrect Procedure or Method; Failure to Deflate; Improper or Incorrect Procedure or Method; Failure to Deflate

  SUBSEQUENT TO THE INITIALLY FILED REPORT, RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE SHAFT WAS SEPARATED. THE ACCOUNT WAS NOT AWARE; HOWEVER, ALL DEVICES IN PLACE WERE REMOVED AS A SINGLE UNIT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621716 ↗
• InjuryOct 25, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT ACUTE CORONARY SYNDROME (ACS) IN THE RIGHT CORONARY ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND THROMBUS IN THE AREA. PRE-DILATATION WAS PERFORMED WITH THE 3.5X15 MM TREK BALLOON DILATATION CATHETER (BDC) AND AT SOME UNKNOWN POINT THE TIP OF THE BDC SEPARATED. THERE WAS NO RESISTANCE DURING ADVANCEMENT OR REMOVAL. THE TIP WAS EMBEDDED INTO THE VESSEL WALL WITH A DRUG ELUTING STENT. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18004230 ↗
• MalfunctionJun 26, 2023Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH NONE TORTUOSITY AND NONE CALCIFICATION. THE 2.50X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE WHEN A RUPTURE OCCURRED AT 16 ATMOSPHERES. THEREFORE, ANOTHER 3.50X15MM TREK BDC WAS INFLATED; HOWEVER, A RUPTURE OCCURRED IN THE FIRST INFLATION AT 15 ATMOSPHERES. ANOTHER TWO TREK BALLOONS WERE USED TO COMPLETED 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 17201213 ↗
• MalfunctionMar 17, 2023Material 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-DILATATION, THE 3.50X15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES (ATM). THEREFORE, THE BALLOON WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A SAME SIZE NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16566783 ↗
• MalfunctionJan 27, 2023Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CIRCUMFLEX WITH HEAVY CALCIFICATION. THE PROCEDURE WAS COMPLEX AND IMPELLA PROTECTED. THE CONTRAST MIX WAS 50:50. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR PROTECTIVE SHEATH AND THE DEVICE WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THE 3.5X15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS USED FOR PRE-DILATATION AND AFTER A STENT WAS DEPLOYED, THE DEVICE WAS USED AGAIN FOR POST DILATATION. THE BALLOON WAS INFLATED THREE TIMES AT NOMINAL PRESSURE AND NEGATIVE WAS HELD FOR 10-15 SECONDS. HOWEVER, IT DID NOT DEFLATE AT ALL AND HAD TO BE REMOVED INFLATED. THE BALLOON CATHETER WAS PULLED HARD DUE TO THE RESISTANCE AND SEPARATED. EVERYTHING HAD TO BE REMOVED AND THE SEPARATED PORTION WAS FOUND ON THE GUIDE WIRE. NOTHING WAS LEFT IN THE PATIENT. 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 16253852 ↗
• MalfunctionNov 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL RIGHT CORONARY ARTERY THAT IS 75% STENOSED. THE 3.5X15MM TREK BALLOON DILATATION CATHETER (BDC) RUPTURE AT 8 ATMOSPHERES DURING THE FIRST INFLATION. A NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15780546 ↗
• MalfunctionOct 13, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY WITH MODERATE CALCIFICATION. THE 3.50X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS USED IN A PROCEDURE AND A BALLOON LEAK OCCURED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. IT IS UNKNOWN AT THIS TIME HOW THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15600017 ↗
• MalfunctionJul 1, 2022Material 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 99% STENOSED, HEAVILY CALCIFIED AND MODERATELY TORTUOUS VESSEL IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. THE 3.5X15MM TREK RX BALLOON DILATATION CATHETER (BDC) HAD RESISTANCE DUE TO THE HEAVILY CALCIFIED PART AT THE ENTRANCE OF THE PROXIMAL LAD BUT CROSSED THE LESION. DURING INFLATION AT 4 ATMOSPHERES (ATMS), THE BALLOON WAS NOT PRESSURIZED AND DEFLATED. THERE WAS NO RESISTANCE DURING WITHDRAWAL. THE DEVICE WAS NOT SOAKED PRIOR TO USE AND THE DEVICE WAS NOT PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR PROTECTIVE SHEATH. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887560 ↗
• MalfunctionJun 30, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS, 90% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). A 3.5X15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE FROM THE ANATOMY AND COULD NOT CROSS TO REACH THE TARGET LESION. THE BDC WAS REMOVED WITH RESISTANCE FROM THE ANATOMY AND THE PROCEDURE RESCHEDULED. A ROTABLATION PROCEDURE IS PLANNED FOR A FUTURE DATE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14881835 ↗
• MalfunctionJun 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY (MRCA) THAT IS 75% STENOSED. THE 3.5X15MM TREK BALLOON DILATATION CATHETER (BDC) RUPTURED AT 3 ATMOSPHERES. ANOTHER NON-ABBOTT BALLOON AND 4.0X18MM XIENCE SKYPOINT WERE USED TO SUCCESSFULLY 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 14681465 ↗
• MalfunctionMay 6, 2022Inflation Problem; Material Rupture; Difficult to Advance; Inflation Problem; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 3.50X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. DURING INFLATION, THE BALLOON WAS ONLY ABLE TO INFLATE TO 5 ATMOSPHERES (ATM) AND UNDER ANGIOGRAPHY A CONTRAST LEAK WAS NOTED. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. AFTER REMOVAL, A RUPTURE ON THE BALLOON WAS CONFIRMED NEAR THE DISTAL BALLOON MARKER. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. ANOTHER NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14311952 ↗
• MalfunctionMar 8, 2022Deflation 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 MILDLY TORTUOUS, 60% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN UNSPECIFIED STENT WAS IMPLANTED AND A 3.5X15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND USED FOR POST-DILATATION WITHOUT ISSUE. THE BALLOON WAS INFLATED 2 TIMES TO 10 ATMOSPHERES (ATM). DURING DEFLATION OF THE TREK BALLOON, THE PHYSICIAN BELIEVED THAT IT TOOK TOO LONG TO DEFLATE THE BALLOON, HOWEVER IT DID FULLY DEFLATE, AND IT IS UNKNOWN HOW LONG NEGATIVE WAS HELD FOR DURING DEFLATION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694616 ↗