TREK™ 1012274-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 08717648138423), received between Apr 18, 2017 and Dec 30, 2025 — classified as 1 death, 4 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (16 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE LESION WAS PRE-DILATED TWICE WITH A 3.00 X 12 MM TREK RX BALLOON DILATATION CATHETER (BDC); HOWEVER, DURING ADVANCEMENT THROUGH THE GUIDING CATHETER FOR THE THIRD TIME FOR ANOTHER DILATION, THE TREK RX BDC SHAFT SNAPPED AND SEPARATED INTO TWO PIECES WITHIN THE GUIDING CATHETER. A NON-ABBOTT 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 23929996 ↗
• MalfunctionSep 23, 2025Illegible Information; Illegible Information

  IT WAS REPORTED AS A GENERAL COMMENT THAT THE REFERENCE SIZE INDICATED ON THE HUB OF THE RX TREK BALLOON DILATATION CATHETER WAS DIFFICULT TO SEE. DURING A PROCEDURE RECENTLY, HE HAD ON HIS TABLE THREE BALLOONS WITH DIFFERENT SIZES AND REFERENCES. PER THE PHYSICIAN, HE HAD DIFFICULTY DISTINGUISHING THE REFERENCES AND HE COULD HAVE MADE A MISTAKE AND IT COULD HAVE HAD CONSEQUENCES FOR THE PATIENT IF THE CARDIOLOGIST HAD USED A 4.0MM BALLOON IN A 2.5MM ARTERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23121235 ↗
• MalfunctionSep 2, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 100% STENOSIS. A NON-ABBOTT BALLOON WAS USED FIRST BUT A RUPTURE OCCURRED. THE 3.0X12 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES AND RUPTURED. AFTER THE RUPTURE A NON-ABBOTT STENT WAS DEPLOYED AND THE PROCEDURE WAS COMPLETED AFTER IMAGING. 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 22940711 ↗
• MalfunctionJun 10, 2025Material 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 TO TREAT A LESION IN THE LEFT CIRCUMFLEX (LCX) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. AFTER PRE-DILATATION WITH A SEMI-COMPLIANT BALLOON, THE 3X12MM TREK BALLOON DILATATION CATHETER (BDC) WAS BEING ADVANCED WITH RESISTANCE WITH THE GUIDE CATHETER AND FORCE WAS APPLIED AGAINST THE RESISTANCE. THE SHAFT OF THE BDC BECAME KINKED AND THEN SEPARATED. THE BDC WAS ABE TO BE SIMPLY WITHDRAWN WITHOUT ISSUE. A NON-ABBOTT SEMI-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 22177306 ↗
• MalfunctionMay 6, 2025Break; Difficult to Remove; Material Separation; Component Missing; Difficult to Advance; Break; Difficult to Remove; Material Separation; Component Missing; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE HEPATIC ARTERY. WHEN THE 3X12MM TREK BALLOON DILATATION CATHETER (BDC) WAS OPENED, THE FLUSHING TOOL WAS NOTED TO NOT BE IN THE PACKAGING. THE BDC WAS ADVANCED WITH RESISTANCE WITH THE GUIDE WIRE (GW); THEREFORE, THE BDC WAS REMOVED AND RESISTANCE WAS ALSO NOTED. AFTER REMOVAL, THE BALLOON OF THE BDC WAS NOTED TO HAVE MOVED ON THE DELIVERY SYSTEM, AS IF THE BALLOON PARTIALLY DETACHED (BROKE). 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 21970137 ↗
• MalfunctionMar 11, 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 LEFT ANTERIOR DESCENDING (DLAD) ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 3X12MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE DUE TO THE ANATOMY TO THE TARGET LESION. THEN THE BALLOON WAS INFLATED TO 8 ATMOSPHERES (ATM); HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED TREK BALLOON. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER TREK BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574588 ↗
• InjuryJan 2, 2025Material Separation; Failure to Deflate; Material Separation; Failure to Deflate

  IT WAS REPORTED THE 3.0X12MM RX TREK BALLOON DILATATION CATHETER (BDC) WAS USED IN AN UNKNOWN ARTERY. THE BALLOON WAS UNABLE TO DEFLATE. THE PHYSICIAN ATTEMPTED TO CAREFULLY REMOVE THE INFLATED BALLOON HOWEVER IT SEPARATED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO SURGICALLY REMOVE THE SEPARATED PORTION OF THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21054184 ↗
• MalfunctionNov 30, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS AND 90% STENOSED MID RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH THE 3.0X12MM TREK BALLOON DILATATION CATHETER(BDC) WHICH WAS PREPPED PER INSTRUCTIONS FOR USE. THE BDC WAS ADVANCED WITH RESISTANCE FELT FROM THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 10 ATMOSPHERES WHEN A RUPTURE OCCURRED. ANOTHER 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 20813859 ↗
• MalfunctionOct 15, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY THAT IS 100% STENOSED. THE 1.5X12MM MINI TREK BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION WITH RESISTANCE FELT WITH ANATOMY; HOWEVER, DURING THE FIRST INFLATION THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM). ADDITIONAL PRE-DILATATION WAS PERFORMED WITH A 1.2X6MM MINI TREK. AFTER A 3.0X12MM TREK BALLOON DILATATION CATHETER WAS USED FOR DILATATION, BUT THE BALLOON RUPTURED DURING FIRST INFLATION AT 6 ATMS. IT WAS NOTED RESISTANCE WAS FELT WITH ANATOMY DURING ADVANCEMENT OF THE 3.0X12MM TREK. A 3.0X6MM NC TREK BALLOON WAS ATTEMPTED TO BE USED, BUT RUPTURED AT THE THIRD INFLATION AT 10 ATMS. ANOTHER UNSPECIFIED BALLOON WAS USED TO 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 20452833 ↗
• MalfunctionJul 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY WITH 75% STENOSIS. AFTER A NON-ABBOTT STENT WAS DEPLOYED, THE 3.0X12MM TREK BALLOON DILATATION CATHETER WAS USED FOR POST-DILATATION, BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 12 ATMOSPHERES(ATM). A 3.0MM NON-ABBOTT BALLOON WAS INFLATED TO 16 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 19799041 ↗
• DeathJul 11, 2024Deflation Problem; Entrapment of Device; Material Rupture; Material Separation; Deflation Problem; Entrapment of Device; Material Rupture; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.0X12MM RX TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION OF A STENT HOWEVER THE BALLOON RUPTURED AND DID NOT DEFLATE. AN ATTEMPT WAS MADE TO REMOVE THE BDC HOWEVER THE SHAFT BROKE AND THE SEPARATED PORTION REMAINED STUCK INSIDE THE LAD. THE PATIENT WAS SENT FOR EMERGENCY SURGERY HOWEVER THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19719994 ↗
• MalfunctionJun 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THE 3.0X12MM TREK BALLOON DILATATION CATHETER (BDC) RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES. ANOTHER TREK 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 19469425 ↗
• MalfunctionJan 14, 2024Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH NO TORTUOSITY. DURING POSITIONING OF THE 3.0X12 MM TREK BALLOON DILATATION CATHETER (BDC), THERE WAS RESISTANCE AND THE SHAFT SEPARATED. THE SEPARATED PORTION WAS PULLED OUT OVER THE WIRE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, IT WAS REPORTED THAT THE RESISTANCE DURING ADVANCEMENT WAS WITH THE ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509848 ↗
• InjuryNov 9, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE CIRCUMFLEX (CX) CORONARY ARTERY WITH NO CALCIFICATION AND NO TORTUOSITY. THE PROCEDURE WAS COMPLETED WITH A 3.0X12MM TREK BALLOON DILATATION CATHETER (BDC); HOWEVER, DURING REMOVAL THE BALLOON BECAME SEPARATED IN TWO PIECES INSIDE THE PATIENT'S BODY; THEREFORE, A STENT WAS USED TO TRAP THE BALLOON PORTION. IT WAS NOTED THAT THE PATIENT BECAME HYPOTENSIVE, DEVELOPED A ST ELEVATED MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK; THEREFORE, A A HEART PUMP WAS USED AND THE PATIENT WAS HOSPITALIZED FOR 7 DAYS. THERE WAS A DELAY IN THE PROCEDURE AND THE PATIENT WAS HOSPITALIZED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiogenic Shock; Low Blood Pressure/ Hypotension; Myocardial Infarction; Obstruction/Occlusion

  MAUDE report 18102979 ↗
• MalfunctionNov 7, 2023Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO THE INITIAL FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: THE GUIDING CATHETER THAT THE 3.0 X 12 MM TREK BALLOON DILATATION CATHETER MET RESISTANCE WITH WAS 6FR. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18085197 ↗
• MalfunctionJul 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE 3.0X12MM TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE INFLATED TO 8 ATMOSPHERES FOR 12 SECONDS; HOWEVER, THE BALLOON WOULD NOT INFLATE (POSSIBLE PINHOLE). ANOTHER SAME SIZE TREK 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 17345052 ↗
• MalfunctionMar 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TOURTUOUS,90% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. A 3.00X12MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITHOUT ISSUE, INFLATED ONE TIME TO 9 ATMOSPHERES (ATM) AND HELD FOR 10 SECONDS 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 XIENCE STENT IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479248 ↗
• MalfunctionJan 31, 2023Stretched; Deformation Due to Compressive Stress; Stretched; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE OSTIAL RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE LESION WAS PREPARED WITH ROTABLATION AND A 4.0X12 MM XIENCE STENT WAS SUCCESSFULLY IMPLANTED. AFTER POST-DILATION OF THE STENT WITH THE NC TREK BALLOON DILATATION CATHETER (BDC) FOR 2 INFLATIONS AT 16 ATMOSPHERES, THE STENT WAS CONFIRMED TO BE APPOSED TO THE VESSEL WALL WITH INTRAVASCULAR ULTRASOUND (IVUS). THERE WAS RESISTANCE DURING REMOVAL; HOWEVER, THE BALLOON WAS NOTED TO BE FULLY DEFLATED. THE MARKERS OF THE BALLOON DID NOT MOVE WHILE WITHDRAWING THE CATHETER SO THE DEVICE WAS STRETCHING. THE NC TREK BALLOON WAS TRAPPED WITH A 3.0X12 MM TREK BDC AND REMOVED ALONG WITH THE GUIDE CATHETER. THE STENT WAS THEN POST-DILATED WITH A NON-ABBOTT NC BALLOON. THE 3.0X12 MM TREK BALLOON BECAME KINKED DURING USE. THERE WERE NO ADVERSE PATIENT SEQUELA. RETURNED DEVICE ANALYSIS IDENTIFIED A STRETCHED INNER MEMBER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16274201 ↗
• MalfunctionAug 15, 2022Deflation Problem; Product Quality Problem; Difficult to Advance; Deflation Problem; Product Quality Problem; Difficult to Advance

  IT WAS REPORTED THAT THIS WAS A PROCEDURE PERFORMED TO TREAT A TARGET LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 3.0 X 12 MM TREK DILATATION CATHETER WAS ADVANCED. RESISTANCE WAS NOTED, AND THE DEVICE WAS UNABLE TO EXIT THE GUIDE CATHETER DUE TO AN UNSPECIFIED STENT DELIVERY SYSTEM THAT WAS IN PLACE. THE TREK WAS REMOVED WITHOUT DIFFICULTY AND WAS SET ASIDE. THE PROCEDURE THEN CONTINUED WITH TREATMENT TO THE 1ST DIAGONAL ARTERY. THE SAME 3.0 X 12 MM TREK DILATATION CATHETER WAS ADVANCED WITHOUT ISSUE AND INFLATED WITHOUT ISSUE. THE BALLOON WAS THEN DEFLATED; HOWEVER, IT SEEMED THAT THE BALLOON DID NOT FULLY DEFLATE AND APPEARED TO HAVE SOME CONTRAST REMAINING IN THE BALLOON. THE TREK WAS ABLE TO BE REMOVED FROM THE ANATOMY WITHOUT DIFFICULTY. HOWEVER, UPON REMOVAL, THE BALLOON APPEARED ABNORMAL. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15230177 ↗
• MalfunctionMar 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.0 X 12 TREK BALLOON RUPTURED DURING INFLATION AT UNKNOWN ATMOSPHERE (ATM). THE DEVICE WAS REPLACED WITH A NON-ABBOTT BALLOON TO COMPLETE THE PROCEDURE. 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 13694842 ↗
• InjuryJan 13, 2022Off-Label Use; Material Rupture; Material Separation; Off-Label Use; Material Rupture; Material Separation

  PATIENT ID: (B)(6). IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT PERONEAL ARTERY. PRE-DILATATION WAS PERFORMED WITH A 3.0 X 12 MM TREK BALLOON DILATATION CATHETER. THE DILATATION CATHETER BALLOON WAS INFLATED 1 TIME TO 8 ATMOSPHERES AND BLOOD WAS NOTED IN THE BALLOON HUB. DURING WITHDRAWAL OF THE DEVICE, THE NC TREK DILATATION CATHETER BALLOON SEPARATED INTO SEVERAL PIECES THAT BROKE OFF THE DISTAL TIP OF THE BALLOON. THE FRAGMENTS EMBOLIZED TO THE DISTAL PERONEAL ARTERY AND THE SUPERFICIAL FEMORAL ARTERY (SFA). THE FRAGMENTS WERE REMOVED WITH A SNARE DEVICE; HOWEVER, A LARGER BALLOON FRAGMENT WAS STUCK TO THE WALL OF THE SFA AND WAS COVERED WITH AN ABSOLUTE STENT. FLOW WAS RESTORED TO THE PERONEAL AND SFA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque; Embolism/Embolus

  MAUDE report 13254349 ↗
• MalfunctionDec 6, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED DE NOVO MID LEFT ANTERIOR DESCENDING ARTERY THAT WAS 99% STENOSED. A 3X12MM TREK BALLOON FAILED TO CROSS DUE TO ANATOMY. DURING WITHDRAWAL, RESISTANCE WAS ALSO MET WITH ANATOMY. ANOTHER NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY 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 12939321 ↗
• MalfunctionMay 19, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE CIRCUMFLEX ARTERY THAT WAS NON CALCIFIED AND NON TORTUOUS. DURING ADVANCEMENT OF THE TREK RX 3.00 X 12MM BDC BALLOON OVER THE GUIDE WIRE, MARKERS WERE NOT OBSERVED UNDER X-RAY. THEREFORE, THE BALLOON CATHETER WAS REMOVED, AND NO MARKERS WERE PHYSICALLY PRESENT. IT WAS DECIDED TO PERFORM DIRECT STENTING TO COMPLETE THE PROCEDURE. 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 11852913 ↗
• MalfunctionMay 18, 2021Inflation Problem; Difficult to Advance; Failure to Deflate; Inflation Problem; Difficult to Advance; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. FOR PRE-DILATATION, A 3X12MM TREK BALLOON WAS ADVANCED TO THE LESION WITH SOME RESISTANCE WITH ANATOMY BUT ULTIMATELY REACHED THE LESION. DURING THE FIRST INFLATION AT 12 ATMOSPHERES, THE BALLOON ONLY PARTIALLY INFLATED. WHEN ATTEMPTING TO DEFLATE, NEGATIVE PRESSURE WAS HELD AROUND 5 SECONDS TO DEFLATE THE BALLOON, BUT THE DEVICE FAILED TO COMPLETELY DEFLATE. ULTIMATELY THE DEVICE WAS SIMPLY WITHDRAWN FULLY INFLATED. ANOTHER TREK BALLOON WAS USED TO SUCCESSFULLY 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 11842270 ↗
• MalfunctionDec 3, 2020Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO MID RIGHT CORONARY ARTERY. A 3X12MM TREK BALLOON FAILED TO CROSS DUE TO ANATOMY AND WHILE BEING REMOVED RESISTANCE WITH ANATOMY WAS ALSO MET. ANOTHER DEVICE WAS USED TO SUCCESSFULLY 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 Consequences Or Impact To Patient

  MAUDE report 10942563 ↗