TREK™ 1012272-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 08717648138300), received between Sep 30, 2016 and Apr 7, 2026 — classified as 6 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (21 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.

• MalfunctionApr 7, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 2.50 X 20 MM RX TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. DURING THE FIRST INFLATION AT 8 ATMOSPHERES, A BALLOON RUPTURE OCCURRED. THE BDC WAS REMOVED AND ANOTHER 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 24799560 ↗
• MalfunctionJan 2, 2026Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A RIGHT POSTERIOR DESCENDING CORONARY ARTERY. UPON REINSERTION AND ADVANCEMENT OF THE 2.50X20MM TREK RX BALLOON DILATATION CATHETER THROUGH THE GUIDE CATHETER, RESISTANCE WAS NOTED DUE TO ANATOMY AND THE SHAFT SEPARATED INTO TWO PIECES WHILE STILL REMAINING IN THE GUIDE CATHETER. AN UNSPECIFIED NON-ABBOTT 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 23946010 ↗
• MalfunctionJun 2, 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 LEFT ANTERIOR DESCENDING (LAD). A 2.5X20MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES AND ADVANCED TO THE LESION THROUGH SLIGHT RESISTANCE; HOWEVER, DURING THE THIRD INFLATION THE BALLOON WAS NOTED TO RUPTURE AT NOMINAL PRESSURE [8ATMS]. THEREFORE, THE BDC WAS REPLACED WITH A 3.0X15MM NON-ABBOTT BDC AND THE LESION WAS TREATED WITH A NON-ABBOTT AND XIENCE STENT. 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 22124895 ↗
• MalfunctionFeb 20, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.5X20M TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE INFLATED; HOWEVER, ALTHOUGH THE DEVICE WAS ATTEMPTED TO BE INFLATED TWICE, NO PRESSURE WAS NOTED AND THE BALLOON FAILED TO INFLATE. THEREFORE, THE BDC WAS REMOVED FROM PATIENT. A NON-ABBOTT BALLOON FOLLOWED BY STENT IMPLANTATION WAS PERFORMED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. RETURN DEVICE ANALYSIS FOUND A LEAK IN THE OUTER MEMBER OF THE 2.5X20M TREK BALLOON DILATATION CATHETER (BDC) AT 3 ATMOSPHERES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21423781 ↗
• MalfunctionNov 21, 2024Failure to Fold; Difficult to Remove; Failure to Fold; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 2.50X20MM RX TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR DILATATION AND WAS INFLATED ONCE TO 12 ATMOSPHERES. AFTER DILATATION, THE BALLOON WAS POORLY FOLDED AND BECAME STUCK ON THE GUIDE WIRE; THEREFORE BOTH DEVICES WERE REMOVED. THE CORONARY GUIDE WIRE WAS REIMPLANTED AND A NEW BALLOON CATHETER 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 20744816 ↗
• 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 19092903 ↗
• MalfunctionMar 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE 2.50X20MM RX TREK BALLOON DILATATION CATHETER WAS REMOVED FROM THE DISPENSER HOOP WITHOUT ISSUE. WHEN HANDLING THE CATHETER FOR PREPARATION, THE HYPOTUBE SEPARATED. A NEW RX TREK WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977711 ↗
• MalfunctionMar 6, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED, MILDLY CALCIFIED, MILD TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY (MLAD) LESION. A 2.50 X20MM RX TREK BALLOON DILATATION CATHETER (BDC) MET RESISTANCE DURING ADVANCEMENT DUE TO THE ANATOMY. THE BDC RUPTURED DURING THE FIRST INFLATION TO 8 ATMOSPHERES. A NON-ABBOTT BALLOON 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 18845057 ↗
• MalfunctionFeb 2, 2024Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.50X20MM RX TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE FELT FROM THE ANATOMY. DURING THE MULTIPLE ATTEMPTS TO CROSS, THE PHYSICIAN WAS PUSHING ON THE HYPOTUBE AND IT SEPARATED. AS THE SEPARATED PORTION WAS OUTSIDE THE PATIENT ANATOMY, THE DISTAL PORTION WAS SIMPLY REMOVED WITHOUT ISSUE. NO RESISTANCE WAS NOTED DURING REMOVAL. THE PROCEDURE WAS COMPLETED USING ANOTHER BDC. 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 18631268 ↗
• MalfunctionDec 6, 2023Deflation Problem; Improper or Incorrect Procedure or Method; Failure to Deflate; Deflation Problem; Improper or Incorrect Procedure or Method; Failure to Deflate

  SUBSEQUENTLY, AFTER THE INITIAL WAS FILED IT WAS NOTED THE 2.5X20 TRAVELER BALLOON SHAFT BENT AND SEPARATED INTO TWO PIECES. THE SEPARATED PORTION WAS ABLE TO SIMPLY BE WITHDRAWN. IT WAS ALSO NOTED THE 2.5X20MM TREK BALLOON WAS REMOVED FULLY DEFLATED AS IT WAS NOTED TO SLOWLY DEFLATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18276904 ↗
• MalfunctionDec 6, 2023Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  SUBSEQUENTLY, AFTER THE INITIAL WAS FILED IT WAS NOTED THE 2.5X20 TRAVELER BALLOON SHAFT BENT AND SEPARATED INTO TWO PIECES. THE SEPARATED PORTION WAS ABLE TO SIMPLY BE WITHDRAWN. IT WAS ALSO NOTED THE 2.5X20MM TREK BALLOON WAS REMOVED FULLY DEFLATED AS IT WAS NOTED TO SLOWLY DEFLATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18276892 ↗
• MalfunctionOct 12, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE NOTED WITH THE LESION AND RUPTURED ON THE FIRST INFLATION AT 8 ATMOSPHERES. A NEW TREK 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 17921381 ↗
• InjuryMay 23, 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 CIRCUMFLEX (CX) ARTERY WITH HEAVY CALCIFICATION. THE 2.50X20MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND INFLATED ONCE WHEN A BALLOON RUPTURE OCCURRED IN 21 SECONDS AT 18 ATMOSPHERES. THE BALLOON WAS TAKEN DOWN AND A PERFORATION WAS NOTED. MULTIPLE BALLOONS WERE USED AND A 2.75 XIENCE SKYPOINT WAS USED TO SEAL THE PERFORATION. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 16985400 ↗
• MalfunctionApr 3, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING DEVICE UNPACKING, WHEN THE 2.5X20MM TREK BALLOON DILATATION CATHETER (BDC) WAS REMOVED FROM THE PACKAGING THE HUB BROKE.. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16670945 ↗
• MalfunctionNov 8, 2022Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE CIRCUMFLEX ARTERY THAT WAS NON-CALCIFIED AND NON-TORTUOUS. THE TREK RX 2.50 X 20MM BALLOON COMPLETELY FAILED TO INFLATE. ANOTHER TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. DEVICE ANALYSIS NOTED THAT FLUID WAS OBSERVED COMING OUT FROM THE TEAR AT THE GUIDE WIRE EXIT NOTCH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15757131 ↗
• MalfunctionAug 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY (MLAD) ARTERY WITH HEAVY CALCIFICATION. THE 2.50X20MM TREK BALLOON DILATATION CATHETER (BDC ) WAS PREPPED PER INSTRUCTION FOR USE (IFU), THEN ADVANCED TO THE TARGET LESION AND INFLATED TO 12 ATMOSPHERES (ATM). AFTER BALLOON DEFLATION AND DURING AN ATTEMPT TO INFLATE THE BALLOON A SECOND TIME, THE BALLOON WOULD NOT INFLATE AND A RUPTURE WAS SUSPECTED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. THE PROCEDURE WAS CONTINUED WITH ANOTHER SAME SIZE TREK BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15263149 ↗
• MalfunctionAug 11, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  T WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, HEAVILY TORTUOUS, 90% STENOSED LESION IN THE LEFT CIRCUMFLEX (CX) ARTERY. A 2.5X20MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED BUT COULD NOT REACH THE TARGET LESION DUE TO RESISTANCE WITH THE ANATOMY. THE BDC WAS REMOVED, ALSO WITH RESISTANCE FROM THE ANATOMY. 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 15214891 ↗
• MalfunctionApr 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MODERATELY CALCIFIED AND TORTUOUS. THE TREK RX 2.50 X 20MM BALLOON WAS ADVANCED TO THE LESION AND RUPTURED DURING THE 1ST INFLATION. THE DEVICE WAS EASILY WITHDRAWN. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER TREK WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190692 ↗
• MalfunctionApr 11, 2022Deflation Problem; Improper or Incorrect Procedure or Method; Difficult to Advance; Deflation Problem; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, 80-99% STENOSED LESION IN THE MID ANTERIOR INTERVENTRICULAR ARTERY (IVA). A 2.5X20MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATATION. THE INITIAL INFLATION WAS TO 14 ATMOSPHERES (ATM) AND HELD FOR 14 SECONDS. THE BDC WAS THEN MOVED A FEW MILLIMETERS TO PRE-DILATATE A MORE PROXIMAL PART OF THE LESION WHEN RESISTANCE WAS NOTED. THE SECOND INFLATION WAS TO 20 ATM AND HELD FOR 10 SECONDS. SUBSEQUENTLY, IMAGING WAS PERFORMED, AND IT WAS NOTED THAT THE BALLOON ONLY PARTIALLY DEFLATED. THE BALLOON WAS ABLE TO BE SUCCESSFULLY REMOVED FROM THE ANATOMY WHILE IT WAS PARTIALLY INFLATED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14075355 ↗
• MalfunctionMar 17, 2022Material Separation; Difficult to Advance; Material Twisted/Bent; Material Separation; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 2.50X20 MM TREK BALLOON DILATATION CATHETER (BDC) WAS BEING LOADED ONTO A NON-ABBOTT GUIDE WIRE WHEN THE BALLOON BUCKLED AND SEPARATED FROM THE SHAFT OF THE CATHETER. THE GUIDE WIRE WOULD NOT ADVANCE ANY FURTHER. THE TREK BDC WAS PREPPED PER THE IFU BUT THE LAB TECH COULD NOT RECALL IF THE GUIDE WIRE HAD BEEN WIPED WITH WET SALINE. THE BALLOON DID NOT ENTER THE PATIENT ANATOMY. A NEW TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS TREATED SUCCESSFULLY AND EVENTUALLY STENTED WITH A 2.75MM X 28MM XIENCE SKYPOINT 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 13792296 ↗
• MalfunctionOct 1, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE ACCOUNT WAS UNPACKING A BOX FOR A 2.5X20MM TREK RX DILATATION CATHETER (1012272-20, 10303G1). ONCE UNPACKED, THE DEVICE INSIDE WAS NOT FOR A TREK RX BUT RATHER AN NC TREK 2.5X15MM (1012435-15). REPORTEDLY, THERE WAS NO TAMPERING WITH THE BOX AND PRODUCT INSIDE PRIOR TO THIS DISCOVERY. THERE WAS NO PROCEDURE AND NO PATIENT INVOLVING THIS DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12564998 ↗
• MalfunctionAug 31, 2021Material Separation; Packaging Problem; Material Separation; Packaging Problem

  IT WAS REPORTED THAT WHEN OPENING AND REMOVING THE 2.5X20MM TREK BALLOON DILATATION CATHETER (BDC) FROM IT'S PACKAGING THE PLASTIC LOOP WAS KINKED AND THE BDC HAD A PROXIMAL SHAFT SEPARATION. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12392604 ↗
• InjuryMar 4, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 2.5X20MM TREK RX BALLOON DILATATION CATHETER WAS PREPARED PER THE INSTRUCTIONS FOR USE WITHOUT ISSUES; HOWEVER, THE BALLOON RUPTURED DURING THE FOURTH INFLATION AT 6-8 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEPLOYMENT OF A 2.5X28MM UNSPECIFIED STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Low Blood Pressure/ Hypotension; No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 11418181 ↗
• MalfunctionFeb 3, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED MID RIGHT CORONARY ARTERY. A 2.5X20MM TREK BALLOON DILATATION CATHETER (BDC) SHAFT SEPARATED INTO TWO PIECES DURING ADVANCEMENT INTO AN UNSPECIFIED GUIDE CATHETER. DEVICE AND SEPARATED PORTION WERE SIMPLY REMOVED AS SEPARATED PORTION WAS IN THE UNSPECIFIED GUIDE CATHETER. A DIFFERENT BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11273476 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE PROXIMAL CIRCUMFLEX ARTERY. THE LESION WAS PRE-DILATED WITH A 2.5X20MM TREK RX BALLOON DILATATION CATHETER (BDC). A 2.5X23MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, FAILED TO CROSS DUE TO RESISTANCE WITH THE ANATOMY. A 2.25X15MM XIENCE SIERRA WAS ADVANCED AND DEPLOYED. A SMALL DISSECTION WAS NOTED, AND BALLOONING WAS PERFORMED. POST PROCEDURE, ANGIO WAS REVIEWED AND IT WAS NOTED THAT THE DISSECTION OCCURRED AFTER PRE-DILATATION WITH THE 2.5X20MM TREK RX BDC. THE 2.5X23MM XIENCE SIERRA SDS NEVER REACHED THE LESION SITE OR DISSECTION. ANGIO REVIEW CONFIRMED THAT THE DISSECTION WAS SUCCESSFULLY TREATED WITH THE DEPLOYMENT OF THE 2.25X15MM XIENCE SIERRA AND BALLOONING. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 11141366 ↗