TREK™ 1012274-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 08717648138447), received between Aug 5, 2016 and Feb 19, 2026 — classified as 2 deaths, 11 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Material Separation” (20 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Deflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION AND ATTEMPTED VACUUMING, THE 3.00X20MM TREK RX BALLOON DILATATION CATHETER (BDC) FAILED TO MAINTAIN NEGATIVE PRESSURE AS RESIDUAL AIR/CONTRAST REMAINED VISIBLE IN THE BALLOON/SHAFT, INDICATING INABILITY TO FULLY COLLAPSE THE BALLOON. A NEW TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR 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 24394005 ↗
• MalfunctionJan 2, 2026Break; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A TORTUOUS RIGHT CORONARY ARTERY. DURING ADVANCEMENT OF THE 3.00X20MM TREK RX BALLOON DILATATION CATHETER (BDC) THROUGH THE GUIDE CATHETER, THE SHAFT SEPARATED WHILE OUTSIDE THE GUIDE CATHETER AND WAS SIMPLY REMOVED. A NEW UNSPECIFIED BALLOON WAS USED TO COMPLETE 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 23946203 ↗
• InjuryNov 19, 2025Material Separation; Material Separation

  SUBSEQUENTLY, AFTER FILING THE REPORT IT WAS NOTED THE SIZE OF THE BALLOON IS A 3.0X20MM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598162 ↗
• MalfunctionSep 26, 2025Material Separation; Deformation Due to Compressive Stress; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 70% STENOSED. AFTER INSERTING A 3.00X20MM TREK RX BALLOON DILATATION CATHETER, THE SHAFT KINKED AND SEPARATED NEAR THE HUB AND WAS SIMPLY WITHDRAWN. 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 23156467 ↗
• InjuryAug 21, 2025Material Separation; Material Separation

  N/A.

  Patient problems: Foreign Body In Patient

  MAUDE report 22863338 ↗
• MalfunctionJan 6, 2025Illegible Information; Illegible Information

  IT WAS REPORTED THAT PRIOR TO USE OF THE 3X20MM TREK BALLOON DILATATION CATHETER (BDC), THE DEVICE INFORMATION LABELED ON THE HUB WAS NOT LEGIBLE TO READ; THEREFORE, THE DEVICE IDENTITY COULD NOT BE DISTINGUISHED, AND THE DEVICE WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080730 ↗
• MalfunctionDec 19, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING THE PROCEDURAL PREPARATION THE CHIPBOARD BOX WAS LABELED AS A 3.0X20MM NC TREK BALLOON DILATATION CATHETER (BDC) (PART 1012274-20 LOT 40417G1); HOWEVER IT WAS NOTED THAT THE DEVICE WITHIN THE PACKAGE DID NOT MATCH WHAT WAS LABELED ON THE BOX. THE DEVICE WITHIN THE PACKAGE WAS NOTED TO BE A 3.0X20MM NC TREK NEO (PART 1400300-20 / LOT 31007G1) INSTEAD OF A NC TREK. ANOTHER NC TREK BDC WAS USED AND THE PROCEDURE WAS COMPLETED. SUBSEQUENT TO FILING THE INITIAL REPORT, UPDATE TO THE EVENT DESCRIPTION CHANGING NC TREK TO TREK: IT WAS REPORTED THAT DURING THE PROCEDURAL PREPARATION THE CHIPBOARD BOX WAS LABELED AS A 3.0X20MM TREK BALLOON DILATATION CATHETER (BDC) (PART 1012274-20 LOT 40417G1); HOWEVER, IT WAS NOTED THAT THE DEVICE WITHIN THE PACKAGE DID NOT MATCH WHAT WAS LABELED ON THE BOX. THE DEVICE WITHIN THE PACKAGE WAS NOTED TO BE A 3.0X20MM NC TREK NEO (PART 1400300-20 / LOT 31007G1) INSTEAD OF A TREK. ANOTHER TREK BDC WAS USED AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20975762 ↗
• MalfunctionDec 18, 2024Break; Failure to Advance; Deformation Due to Compressive Stress; Break; Failure to Advance; Deformation Due to Compressive Stress

  SUBSEQUENTLY, AFTER THE INITIAL WAS FILED IT WAS NOTED THAT THE SHAFT WAS ONLY KINKED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20967318 ↗
• MalfunctionApr 11, 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 THAT THE PROCEDURE WAS TO TREAT THE HIGHLY CALCIFIED OSTIUM OF THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 1.2X15 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE NOTED WITH THE ANATOMY AND A PREVIOUSLY IMPLANTED STENT. THE BALLOON WAS INFLATED 6 TIMES UP TO 14 ATMOSPHERES (ATM) IN THE PROXIMAL AND MIDDLE PORTIONS OF THE LESION BUT RUPTURED AT 8 ATM IN THE OSTIUM. NEXT, THE 2.5X20 MM TREK BDC WAS ADVANCED WITH RESISTANCE NOTED WITH THE SEVERE CALCIUM AND A PREVIOUSLY IMPLANTED STENT. THE BALLOON WAS INFLATED 3 TIMES UP TO 14 ATM IN THE PROXIMAL AND MIDDLE PORTIONS BUT RUPTURED AT 8 ATM IN THE OSTIUM. THE 2.0X20 MM MINI TREK BDC WAS ADVANCED WITH RESISTANCE NOTED WITH THE ANATOMY AND A PREVIOUSLY IMPLANTED STENT AND WAS INFLATED ONCE IN THE PROXIMAL MIDDLE OF THE LESION. WHEN ATTEMPTING TO INFLATE IN THE OSTIUM, THE BALLOON RUPTURED AT 8 ATM. THE 3.0X20 MM TREK BDC WAS ADVANCED WITH RESISTANCE NOTED WITH THE LESION AND A PREVIOUSLY IMPLANTED STENT AND WAS INFLATED TWICE IN THE MIDDLE AND PROXIMAL PORTION UP TO 20 ATM WITHOUT ISSUE. WHEN INFLATED THE THIRD TIME IN THE OSTIUM, THE BALLOON RUPTURED AT 9 ATM. FINALLY, THE 3.0X20 MM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19092840 ↗
• MalfunctionApr 11, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HIGHLY CALCIFIED OSTIUM OF THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 1.2X15 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE NOTED WITH THE ANATOMY AND A PREVIOUSLY IMPLANTED STENT. THE BALLOON WAS INFLATED 6 TIMES UP TO 14 ATMOSPHERES (ATM) IN THE PROXIMAL AND MIDDLE PORTIONS OF THE LESION BUT RUPTURED AT 8 ATM IN THE OSTIUM. NEXT, THE 2.5X20 MM TREK BDC WAS ADVANCED WITH RESISTANCE NOTED WITH THE SEVERE CALCIUM AND A PREVIOUSLY IMPLANTED STENT. THE BALLOON WAS INFLATED 3 TIMES UP TO 14 ATM IN THE PROXIMAL AND MIDDLE PORTIONS BUT RUPTURED AT 8 ATM IN THE OSTIUM. THE 2.0X20 MM MINI TREK BDC WAS ADVANCED WITH RESISTANCE NOTED WITH THE ANATOMY AND A PREVIOUSLY IMPLANTED STENT AND WAS INFLATED ONCE IN THE PROXIMAL/MIDDLE OF THE LESION. WHEN ATTEMPTING TO INFLATE IN THE OSTIUM, THE BALLOON RUPTURED AT 8 ATM. THE 3.0X20 MM TREK BDC WAS ADVANCED WITH RESISTANCE NOTED WITH THE LESION AND A PREVIOUSLY IMPLANTED STENT AND WAS INFLATED TWICE IN THE MIDDLE AND PROXIMAL PORTION UP TO 20 ATM WITHOUT ISSUE. WHEN INFLATED THE THIRD TIME IN THE OSTIUM, THE BALLOON RUPTURED AT 9 ATM. FINALLY, THE 3.0X20 MM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19092789 ↗
• MalfunctionDec 11, 2023Break; Peeled/Delaminated; Difficult to Remove; Break; Peeled/Delaminated; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT AND RIGHT RENAL ARTERIES WITH MILD CALCIFICATION AND MILD TORTUOSITY. WHEN THE 3.0X20 MM TREK BALLOON DILATATION CATHETER WAS BEING REMOVED FROM THE PATIENT, THERE WAS RESISTANCE WITH THE GUIDE WIRE AND THE BALLOON SHREDDED [PEELED] BUT DID NOT SEPARATE FROM THE BALLOON AND THE CATHETER SPLIT IN THE MIDDLE PORTION BUT WAS NOT IN TWO PIECES. NO MATERIAL WAS LEFT IN THE PATIENT. 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 18303082 ↗
• MalfunctionSep 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 3.0X20MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS SOAKED IN SALINE PRIOR TO USE BUT WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO RESISTANCE WHEN THE PROTECTIVE SHEATH WAS REMOVED. THERE WAS NO RESISTANCE DURING ADVANCEMENT AND THE BALLOON WAS INFLATED ONCE TO 10 ATMOSPHERES (ATMS) BUT THE BALLOON RUPTURED. THERE WAS NO RESISTANCE DURING REMOVAL. ANOTHER BALLOON WAS USED TO CONTINUE 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 17694911 ↗
• DeathAug 1, 2023Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Deflate; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Deflate

  SUBSEQUENTLY, AFTER THE INITIAL WAS FILED IT WAS NOTED THAT THROMBOSIS WAS NOTED WHERE THE XIENCE AND THE OTHER NON-ABBOTT STENT WERE IMPLANTED. FURTHERMORE, A NON-ABBOTT WAS ALSO PREVIOUSLY IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY ALONG WITH THE XIENCE STENT. RESISTANCE DURING REMOVAL OF THE TREK BALLOON WAS NOTED AS IT REMAINED FULLY INFLATED WHEN ATTEMPTING TO REMOVE. CARDIAC BYPASS WAS PERFORMED TO REMOVE THE BALLOON; HOWEVER, IT IS UNKNOWN IF THE SEPARATED PORTION WAS REMOVED. PATIENT'S CAUSE OF DEATH WAS NOTED TO BE CARDIOGENIC SHOCK AS THE PATIENT FULLY CODED AND FOR TREATMENT INTRA-AORTIC BALLOON PUMP AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). HOWEVER, THE PATIENT DIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Cardiogenic Shock; Foreign Body In Patient

  MAUDE report 17436026 ↗
• MalfunctionJul 18, 2023Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION AND NO TORTUOSITY. THE 3.0X20 MM TREK BALLOON DILATATION CATHETER (BDC) WAS NOT SOAKED PRIOR TO USE AND WAS INFLATED ONCE TO 14 ATMOSPHERES AND ONCE TO 8 ATMOSPHERES WHEN THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND A 3.0X20 MM NC TREK BDC WAS USED TO CONTINUE THE PROCEDURE FOLLOWED BY A 3.5X20 MM NC TREK AND A NON-ABBOTT STENT. 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 17346144 ↗
• MalfunctionJul 10, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). A 3.00X20MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED, HOWEVER IT COULD NOT CROSS THE DIFFICULT ANATOMY. THE BDC WAS REMOVED WITH RESISTANCE MET WITH THE ANATOMY. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 17288659 ↗
• MalfunctionNov 15, 2022Inflation Problem; Difficult to Advance; Material Split, Cut or Torn; Inflation Problem; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.0X20MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR PRE-DILATATION WITH RESISTANCE FROM THE ANATOMY AND INFLATED ONE TIME TO 10 ATMOSPHERES (ATM), HOWEVER THE BALLOON ONLY PARTIALLY INFLATED, AND A TEAR WAS NOTED IN THE BALLOON. THE PARTIAL INFLATION AND TEAR ARE SUSPECTED TO BE CAUSED BY THE CALCIFICATION IN THE LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15802087 ↗
• InjuryNov 9, 2021Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CHEST PAIN AND RESTENOSIS. THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED VESSEL IN THE PROXIMAL CIRCUMFLEX ARTERY AND THE 3.0X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR PRE-DILATATION. RESISTANCE WAS FELT DUE TO THE HEAVILY CALCIFIED LESION AND THE BDC WAS INFLATED ONCE WITH A PRESSURE OF 20 ATMOSPHERES (ATMS). AT THIS POINT THE PHYSICIAN DID NOT KNOW THAT UPON REMOVAL, THE BALLOON HAD DETACHED FROM THE DELIVERY SYSTEM. MODERATE FORCE HAD BEEN APPLIED DUE TO THE NATURE OF THE CALCIUM IN THE ANATOMY. ANOTHER STENT WAS PLACED AND THE BALLOON MARKERS WERE NOTED ON CHECK IMAGING. THE BALLOON HAD MOVED TO THE DISTAL CIRCUMFLEX. THE DISTAL CIRCUMFLEX ARTERY HAD NO BLOOD FLOW FOR A SHORT TIME, HOWEVER, THE PATIENT REMAINED STABLE THROUGHOUT. SNARE WAS CONSIDERED BUT NOT ATTEMPTED DUE TO THE SMALL VESSEL. A MEDTRONIC STENT WAS USED TO EMBED THE BALLOON IN THE HEALTHY TISSUE OF THE DISTAL CIRCUMFLEX. THERE WAS NO REPORTED SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 12782556 ↗
• InjuryAug 9, 2021Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED VESSEL IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 3.0X20MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER AN UNSPECIFIED GUIDE WIRE TO THE TARGET LESION WITH NO ISSUES. HOWEVER, THE BALLOON RUPTURED AT 18 ATMOSPHERES DURING THE FIRST INFLATION. DURING REMOVAL, SLIGHT RESISTANCE WAS FELT WHEN REMOVING THE BALLOON OUT OF THE HEAVILY CALCIFIED LESION AND THE DISTAL SHAFT BECAME SEPARATED. THE PROXIMAL END OF THE BDC WAS REMOVED AND THE DISTAL END OF THE BDC REMAINED STUCK ON THE GUIDE WIRE IN THE PATIENT. A CROSS CATHETER WAS USED TO SUCCESSFULLY REMOVE THE SEPARATED SHAFT WITH THE GUIDE WIRE. ANOTHER UNSPECIFIED 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 12297629 ↗
• MalfunctionJul 27, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MID LEFT ANTERIOR DESCENDING ARTERY. A GUIDE WIRE WAS INSERTED AND ADVANCED TO THE LESION. WHEN ADVANCING THE 3X20MM TREK BALLOON OVER THE GUIDE WIRE, THE SHAFT BROKE IN TWO PIECES (STILL OUTSIDE OF THE ANATOMY). ANOTHER TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO RESISTANCE NOTED WHEN ADVANCING THE TREK. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED MDR REPORT, THE ACCOUNT CONFIRMED THAT THE LESION WAS MODERATELY TORTUOUS, MODERATELY CALCIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229706 ↗
• MalfunctionNov 17, 2020Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  SUBSEQUENT TO THE PREVIOUS MEDWATCH REPORT FILED, THE ADDITIONAL INFORMATION WAS REPORTED: THE BALLOON BURST AT 6 ATMOSPHERES. THERE WAS NO DEVICE ASPIRATION PERFORMED DUE TO THIS ISSUE AND NO ADVERSE PATIENT EFFECT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10856573 ↗
• MalfunctionOct 16, 2020Off-Label Use; Material Separation; Failure to Advance; Off-Label Use; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT TIBIAL TRUNK. A 3X20MM TREK BALLOON DILATATION CATHETER (BDC) FACED RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT, AND THE SHAFT SEPARATED INTO TWO PIECES. THE BDC WAS REMOVED WITHOUT ISSUE, AND NO PORTION OF THE DEVICE REMAINS IN THE ANATOMY. AN UNSPECIFIED 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 Consequences Or Impact To Patient

  MAUDE report 10690753 ↗
• DeathOct 8, 2020Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN ST ELEVATED MYOCARDIAL INFARCTION AND THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). A 3.0X20MM TREK RX BALLOON DILATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE FROM THE CALCIFIED ANATOMY. DURING THE FIRST INFLATION THE BALLOON OF THE BDC RUPTURED AT 20 ATMOSPHERES. WHEN RETRACTING THE BDC, RESISTANCE WITH THE ANATOMY WAS FELT AND THE BALLOON SEPARATED FROM THE BDC SHAFT AND WAS STUCK IN THE RCA. SEVERAL SNARE DEVICES AND UNSPECIFIED GUIDE WIRES WERE USED TO TRY TO REMOVE THE SEPARATED SEGMENT OF THE BALLOON BUT WERE UNSUCCESSFUL. THE SEPARATED SEGMENT REMAINED EMBEDDED TO THE VESSEL WALL. A CLINICALLY SIGNIFICANT DELAY WAS REPORTED IN THE PROCEDURE AND HOSPITALIZATION WAS PROLONGED. THE PATIENT EXPIRED THE NEXT DAY DUE TO HEART FAILURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death; Heart Failure; Vessel Or Plaque, Device Embedded In

  MAUDE report 10649560 ↗
• InjuryOct 7, 2020Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  SUBSEQUENT TO THE INITIAL REPORT FILED, USER FACILITY MEDWATCH REPORT (MW5097052) RECEIVED STATING: "SHAFT OF THE ABBOTT TREK BALLOON BROKE OFF IN PATIENT'S RIGHT LEG DURING ANGIOPLASTY PROCEDURE." THE FACILITY REPORTER WAS CONTACTED AND THE CORRECT DEVICE WAS CONFIRMED AS TREK CORONARY DILATATION CATHETER 1012274-20, LOT 90220G1.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10645895 ↗
• MalfunctionSep 23, 2020Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION LOCATED IN THE LEFT MAIN CORONARY ARTERY. A GUIDING CATHETER WAS ADVANCED AND CAUSED A DISSECTION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. A NON-ABBOTT STENT WAS IMPLANTED, AND A PERFORATION WAS NOTED. THE TREK RX BALLOON CATHETER WAS ADVANCED, AND POST-DILATATION WAS PERFORMED WITHOUT ISSUE, HOWEVER, AFTER BALLOON DEFLATION, AND DURING REMOVAL, RESISTANCE WAS NOTED, FORCE WAS APPLIED, AND THE DISTAL SHAFT SEPARATED. ALL DEVICES WERE REMOVED AS A SINGLE UNIT. THE TREK RX DID NOT CAUSE, CONTRIBUTE TO ANY PATIENT ADVERSE EFFECT, OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THE PATIENT WAS SENT TO SURGERY FOR REPAIR OF THE PERFORATION. SURGERY WAS NOTED TO BE SUCCESSFUL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10577779 ↗
• MalfunctionAug 18, 2020Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT ANTERIOR TIBIAL ARTERY. A 3.0X20MM TREK BALLOON WAS INSERTED THROUGH A 4FR MICRO CATHETER AND ADVANCED TO THE LESION WITHOUT ISSUE. WHEN INFLATED ONCE THE BALLOON RUPTURED AT 8 ATMOSPHERES. AS THE BALLOON WAS BEING REMOVED, THE PROXIMAL SHAFT BROKE IN TWO PIECES. WHEN THE MICRO CATHETER WAS SIMPLY PULLED OUT, THE REST OF THE DEVICE CAME OUT WITH IT. 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 10422091 ↗