TREK™ 1012272-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 158 adverse event reports that list this exact device (DI 08717648138294), received between Oct 27, 2016 and Sep 30, 2026 — classified as 2 deaths, 12 injuries, 144 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (106 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 158 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Rupture; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949012 ↗
• InjuryMay 19, 2026Improper or Incorrect Procedure or Method; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.5X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH 100% CONTRAST MIX. THEN THE BDC WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE BALLOON WOULD NOT DEFLATE. THEREFORE, THE BALLOON HAD TO BE CUT AND REMOVED FROM THE WIRE. ANOTHER SAME SIZE TREK BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221446 ↗
• MalfunctionJan 27, 2026Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED DURING PREPARATION OF A TREK 2.5X15MM, THERE WERE CREASES OBSERVED ON THE PACKAGING AND DISPENSER COIL. THEREFORE, THE DEVICE WAS NOT USED AND WAS REPLACED. STERILITY OF THE DEVICE COULD NOT BE CONFIRMED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193013 ↗
• MalfunctionDec 29, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS, AND 75% STENOSED LEFT ANTERIOR DESCENDING ARTERY. A TREK RX 2.50X15MM BALLOON DELIVERY CATHETER (BDC) WAS INSERTED AND ADVANCED BUT WAS DIFFICULT TO CROSS THE LESION. ONCE CROSSED, DILATION WAS PERFORMED. HOWEVER, THE BDC RUPTURED AT 12ATM. THEREFORE, THE BDC WAS REMOVED WITHOUT FURTHER ISSUES AND REPLACED WITH A NON-ABBOTT 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 23907016 ↗
• MalfunctionDec 11, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 2.50X15MM RX 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 (ATM). 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 23777169 ↗
• MalfunctionNov 19, 2025Improper or Incorrect Procedure or Method; Failure to Deflate; Improper or Incorrect Procedure or Method; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 100% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 2.5X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS USED TO FOR DILATATION AT 8 ATMOSPHERES (ATM); HOWEVER, AFTER COMPLETION OF DILATATION, THE BALLOON FAILED TO DEFLATE. THE INDEFLATOR WAS REMOVED AND RECONNECTED, BUT THE BALLOON STILL WOULD NOT DEFLATE. ALTHOUGH, THE BALLOON REMAINED INFLATED; THE BDC WAS ABLE TO REMOVED WITHOUT ISSUE. A NON-ABBOTT BDC 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 23601141 ↗
• MalfunctionNov 13, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, HEAVILY TORTUOUS RIGHT CORONARY ARTERY THAT IS 75% STENOSED. THE 2.5X15MM TREK BALLOON BALLOON DILATATION CATHETER MET RESISTANCE DURING ADVANCEMENT WITH ANATOMY. ONCE AT THE TARGET LESION SITE THE BALLOON WAS INFLATED AT 8 ATMOSPHERES (ATM) AND DURING THE SECOND INFLATION AT 12 ATM THE BALLOON RUPTURED. THEREFORE, ANOTHER NON-ABBOTT BALLOON WAS USED TO PRE-DILATATION. 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 23547749 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE POSTERIOR DESCENDING ARTERY WITH HEAVY CALCIFICATION. THE 2.5X15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCING ON THE GUIDE CATHETER WITHOUT RESISTANCE WHEN THE HYPOTUBE SNAPPED. THERE WAS NO EXCESSIVE FORCE APPLIED. THE SEPARATED PORTIONS WERE SIMPLY PULLED AND REMOVED FROM THE GUIDE CATHETER. THE GUIDE CATHETER REMAINED IN THE ANATOMY AND WAS USED WITH ANOTHER TREK RX THAT COMPLETED 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 23306289 ↗
• MalfunctionSep 19, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 50% STENOSED DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 2.5X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED TO 8 ATMOSPHERES (ATM); HOWEVER, THE BALLOON RUPTURED. 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 23097636 ↗
• MalfunctionAug 26, 2025Material 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 MODERATELY CALCIFIED AND TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). A 2.5X15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE USED FOR DILATATION; HOWEVER THE BALLOON WAS NOTED TO RUPTURE AT 12ATMS DURING THE SECOND INFLATION. THEREFORE THE BDC WAS REPLACED WITH ANOTHER SAME SIZED 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 22899016 ↗
• MalfunctionAug 5, 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 DISTAL RIGHT CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF A 2.50X15MM TREK RX BALLOON DILATATION CATHETER, RESISTANCE WAS NOTED DUE TO ANATOMY. ONCE AT THE LESION FOR PRE-DILATION, THE TREK RX BALLOON RUPTURED AT 12 ATMOSPHERES DURING THE FIRST INFLATION. A 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 22717644 ↗
• MalfunctionJul 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 2.5X15 MM TREK BALLOON DILATATION CATHETER (BDC) RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES. AN NC 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 22441049 ↗
• MalfunctionMay 29, 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 PROXIMAL RIGHT CORONARY ARTERY (PRCA). AFTER THE LESION WAS CROSSED WITH AN UNKNOWN GUIDEWIRE, A 1.5X12MM NON- ABBOTT BALLOON DILATATION CATHETER (BDC) WAS INFLATED; HOWEVER, RUPTURED AT 8ATMS, DUE TO THE SEVERE CALCIFICATION. AT THIS POINT, A 2.5X15MM TREK RX BDC WAS PREPARED, WITH NO NOTED ISSUES, AND ADVANCED TO THE LESION THROUGH RESISTANCE, AS A REPLACEMENT, BUT DURING THE FIRST INFLATION AT 6ATMS, A PINHOLE RUPTURE WAS NOTED. THEREFORE, THE BDC WAS REMOVED AND ANOTHER BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106755 ↗
• MalfunctionMay 14, 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 LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.5X15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES AND ADVANCED TO THE LESION THROUGH RESISTANCE; HOWEVER, DURING THE SECOND INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 8ATM. THEREFORE, THE BDC WAS REMOVED AND A NEW TREK BDC WAS USED AND THE PROCEDURE WAS CONTINUED. 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 22021178 ↗
• MalfunctionMar 14, 2025Material 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 PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF A 2.50X15MM TREK BALLOON DILATATION CATHETER, RESISTANCE WAS FELT WITH ANATOMY. ONCE AT THE LESION THE BALLOON WAS INFLATED TWICE TO 23 ATMOSPHERES BUT RUPTURED AT 12 ATMOSPHERES ON THE SECOND INFLATION. THEREFORE, A 2.00X15MM MINI TREK BALLOON DILATATION WAS ADVANCED BUT MET RESISTANCE WITH ANATOMY. ONCE AT THE LESION THE BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. A 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 21609853 ↗
• MalfunctionFeb 7, 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 MID LEFT ANTERIOR DESCENDING ARTERY. THE 2.50X15MM RX TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED. THE BALLOON RUPTURED DURING THE SECOND 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 21332978 ↗
• MalfunctionFeb 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT AN UNKNOWN VESSEL. AFTER THE PLACEMENT OF THE 2.50X15MM TREK CORONARY DILATATION CATHETER, LEAKAGE FROM THE TREK BALLOON WAS OBSERVED. THE BALLOON WAS RETRIEVED AND A NEW 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 21307424 ↗
• MalfunctionJan 7, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND A MODERATE TORTUOSITY. FOR PRE-DILATATION, THE 2.5X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FOR 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 21095358 ↗
• MalfunctionDec 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILD CALCIFICATION, MILDLY TORTUOUS AND 90% STENOSED DISTAL RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH THE 2.0X15MM MINI 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 2.5X15MM TREK BDC YET THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES WHEN A RUPTURE OCCURRED AFTER 5 SECONDS. ADDITIONAL DILATATION WAS PERFORMED WITH A NON-ABBOTT ROTABLATION DEVICE AND A 2.0X20MM TREK BDC WAS USED TO CONTINUE 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 20837778 ↗
• MalfunctionOct 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT MODERATELY CALCIFIED, MODERATELY TORTUOUS PROXIMAL LEFT CIRCUMFLEX ARTERY WITH 90% STENOSIS. A 2.50X15MM TREK BALLOON DILATATION CATHETER WAS ADVANCED FOR PRE-DILATATION; HOWEVER, RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. ROTABLATION WAS PREFORMED AND A NEW 2.5X15MM 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 20507301 ↗
• MalfunctionOct 9, 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 MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 80% STENOSIS. THE 2.5X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR PRE-DILATATION, WITH RESISTANCE WAS NOTED DUE TO THE LESION ANATOMY. THE BALLOON WAS INFLATED TO 6 ATMOSPHERES (ATM) AND A RUPTURE OCCURRED. A NEW TREK BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO 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 20411258 ↗
• MalfunctionJul 24, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION OF THE 2.5X15MM TREK RX BALLOON DILATION CATHETER, THE HYPOTUBE WAS NOTED TO BE SEPARATED INTO TWO PIECES. ANOTHER TREK BALLOON 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 19819610 ↗
• MalfunctionJun 19, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION, HEAVY TORTUOSITY AND 90% STENOSIS. PRE-DILATION WAS PERFORMED WITH THE 2.5X15 MM TREK RX BALLOON DILATATION CATHETER (BDC), WHICH WAS PREPPED PER THE INSTRUCTIONS FOR USE. THE BDC WAS ADVANCED WITH RESISTANCE NOTED FROM THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 8 ATMOSPHERES WHEN IT 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 19568617 ↗
• MalfunctionJun 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS DISTAL RIGHT CORONARY ARTERY THAT IS 75% STENOSED. THE 2.5X15MM TREK BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION; HOWEVER, DURING THE FIRST INFLATION THE BALLOON RUPTURED AT 8 ATMOSPHERES. THEREFORE, A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE AND A 2.5X38MM XIENCE SKYPOINT WAS IMPLANTED. A 2.5X15MM NON-ABBOTT BALLOON WAS USED TO PREFORM POST DILATATION. 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 19547542 ↗
• MalfunctionJun 12, 2024Difficult to Remove; Material Separation; Deformation Due to Compressive Stress; Difficult to Advance; Difficult to Remove; Material Separation; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DIAGONAL BRANCH OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.5X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE ADVANCED FOR POST DILATATION; HOWEVER, RESISTANCE WAS MET WITH THE GUIDE LINER AND THE SHAFT OF THE BDC KINKED. DURING REMOVAL, THE PROXIMAL SHAFT SEPARATED WHILE STILL INSIDE THE GUIDELINER. THEREFORE, THE BDC AND THE GUIDELINER WAS REMOVED FROM THE PATIENT AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19523800 ↗