TREK™ 1012280-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 08717648138782), received between May 31, 2017 and Jun 25, 2025 — classified as 8 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (15 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2025Deflation Problem; Off-Label Use; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Off-Label Use; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY TORTUOUS, RIGHT RENAL ARTERY THAT IS 90% STENOSED. ONCE AT THE LESION, A 5.00X15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE AT 10 ATMOSPHERES FOR PRE-DILATION. DURING REMOVAL OF THE PARTIALLY DEFLATED TREK RX BALLOON, RESISTANCE WAS MET WITH THE GUIDE CATHETER AND THE TREK RX BALLOON SEPARATED. WHEN PULLING THE GUIDE CATHETER OUT, THE TREK RX BDC TIP MOVED DOWNSTREAM TO THE POPLITEAL ARTERY. A 7 FRENCH SHEATH WAS INSERTED IN THE FEMORAL ARTERY TO RETRIEVE THE TREK RX BDC TIP VIA SNARE. AN UNSPECIFIED STENT WAS USED TO COMPLETE THE PROCEDURE AS INTENDED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22332354 ↗
• InjuryJan 27, 2025Off-Label Use; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Failure to Deflate; Off-Label Use; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO DILATATE THE LEFT PULMONARY ARTERY. THE 5.00X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE AT 10 ATMOSPHERES. NEGATIVE WAS HELD A FEW MINUTES AND THE BALLOON WOULD NOT DEFLATE. THE BALLOON WAS REMOVED FULLY INFLATED WITH A SNAKE [SNARE] AND A NEW UNSPECIFIED STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA; HOWEVER, CLINICALLY SIGNIFICANT DELAY WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21242931 ↗
• MalfunctionDec 13, 2024Deflation Problem; Off-Label Use; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Off-Label Use; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS RIGHT RENAL ARTERY. THE 5.0X15MM TREK BALLOON DILATATION CATHETER WAS NOTED TO SLOWLY DEFLATE AND ONLY PARTIALLY DEFLATE AFTER INFLATION. DURING REMOVAL FORCE WAS APPLIED IN ATTEMPT TO REMOVE THE BALLOON HOWEVER, COULD NOT BE REMOVED INDEPENDENTLY AND RESISTANCE WAS FELT WITH ANATOMY. THE TIP SEPARATED AND WAS SAFELY PULLED INTO THE GUIDE CATHETER. THE GUIDE CATHETER, BALLOON AND GUIDE WIRE WERE REMOVED AS ONE UNIT. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926374 ↗
• InjuryMay 31, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. THE HI-TORQUE (HT) PILOT 50 GUIDE WIRE FAILED TO CROSS DUE TO THE ANATOMY. A 90 DEGREE ANGLED MICROCATHETER WAS ADVANCED DUE TO THE ANGULATION AND WAS THEN ABLE TO ADVANCE THE SAME HT PILOT 50 GUIDE WIRE WITH DIFFICULTY INTO THE DISTAL LAD (DLAD). ASPIRATION THROMBECTOMY WAS PERFORMED. THEN A COMPLIANT 2.5MM BALLOON WAS USED TO PERFORM ANGIOPLASTY TO THE PROXIMAL AND DISTAL LAD. DISTAL OCCLUSION WAS STILL NOTED LIKELY DUE TO CLOT EMBOLIZATION SO I WENT BACK WITH PENUMBRA CATHETER TO PERFORM ADDITIONAL ASPIRATION THROMBECTOMY. THEN AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS ADVANCED TO THE MID LAD AND IVUS WAS RECORDED TO ASSESS VESSEL CHARACTERISTICS AND REFERENCE DIAMETERS FOR STENT SIZING. DISSECTION WAS NOTED IN MID LAD. A 4.0X18MM XIENCE SKYPOINT STENT WAS THEN DEPLOYED OVER THE PROX-MID LAD. THE 5.0X15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE AND USED TO POST-DILATE THE STENT PER STANDARD PROCEDURE. AFTER REMOVAL OF THE BALLOON CATHETER, THE BALLOON WAS NOTED TO BE DISLODGED AT DISTAL EDGE OF GUIDE CATHETER DUE TO RESISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19440831 ↗
• MalfunctionSep 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT MAIN CORONARY ARTERY WITH MODERATE CALCIFICATION AND 90% STENOSIS. THE 5.0X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS BEING USED FOR PRE DILATION; HOWEVER, A RUPTURE OCCURRED AT THE FIRST INFLATION AT 8 ATMOSPHERES. ANOTHER NON-ABBOT DEVICE 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 17732657 ↗
• MalfunctionJun 14, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, RETURN DEVICE ANALYSIS FOUND THAT AN UNSPECIFIED EXTRA S¿PORT GUIDE WIRE WAS RETURNED, FROZEN WITH THE REPORTED TREK BALLOON DILATATION CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131225 ↗
• MalfunctionMay 23, 2023Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE CIRCUMFLEX ARTERY (CX). THE 5.0X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS BEING ADVANCED WHEN RESISTANCE WAS MET WITH THE GUIDE CATHETER. THE DEVICE NEVER EXITED THE GUIDING CATHETER AND WAS NEVER INFLATED. THE BALLOON WAS REMOVED, AND RESISTANCE WAS MET WITH THE GUIDING CATHETER. THE TIP OF THE BALLOON WAS NOTED SEPARATED BUT REMAINED IN THE GUIDING CATHETER. AFTER REMOVAL, THE GUIDING CATHETER WAS FLUSHED AND THE TIP CAME OUT, CONFIRMING THAT NOTHING WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED. 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 16985251 ↗
• InjuryApr 7, 2023Difficult 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 DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH 70% STENOSIS, MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 5.0X15MM TREK RX BALLOON DILATATION CATHETER (BDC) HAD NO RESISTANCE DURING ADVANCEMENT AND WAS SUCCESSFULLY USED FOR POST-DILATATION. HOWEVER, THE DEFLATED BALLOON COULD NOT BE RETRIEVED THROUGH THE GUIDING CATHETER DUE TO RESISTANCE. THE BALLOON WAS INFLATED AND DEFLATED SEVERAL TIMES IN ATTEMPTS TO GET THROUGH THE GUIDING CATHETER. FORCE WAS APPLIED. THE GUIDING CATHETER AND THE BALLOON WERE REMOVED TOGETHER BUT IT WAS NOTED THAT THE DISTAL PORTION OF THE BALLOON WAS LEFT IN THE AORTA. A SNARE DEVICE WAS USED TO RETRIEVE THE SEPARATED PORTION. THERE WAS NO ADVERSE PATIENT SEQUELAE 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 16701723 ↗
• MalfunctionNov 7, 2022Difficult to Insert; Material Deformation; Material Split, Cut or Torn; Difficult to Insert; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 5.00X15MM TREK BALLOON DILATION CATHETER (BDC) WAS ATTEMPTED TO BE LOADED ONTO A NON-ABBOTT GUIDEWIRE (GW); HOWEVER, THE TIP OF THE BDC WAS NOT OPEN. THEREFORE THE GW WAS NOT ABLE TO BE INSERTED INTO THE BDC. THE BDC WAS NOT USED IN THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER TREK WAS USED TO CONTINUE THE PROCEDURE. DEVICE RETURN ANALYSIS FOUND A HOLE IN THE INNER MEMBER PROXIMAL FROM THE PROXIMAL SEAL OF THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15749484 ↗
• MalfunctionOct 24, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 5.0X15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST-DILATATION, HOWEVER, THE BALLOON WAS UNABLE TO BE REMOVED AFTER DEFLATION. THE TREK RX BDC WAS REMOVED TOGETHER WITH THE OTHER DEVICES AS A UNIT. ANOTHER 5.0X15MM TREK RX BDC WAS USED AND WAS UNABLE TO BE REMOVED AGAIN AFTER DEFLATION. THE TREK RX BDC WAS REMOVED TOGETHER WITH THE GUIDE WIRE AS A UNIT. 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 15657838 ↗
• MalfunctionOct 24, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 5.0X15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST-DILATATION, HOWEVER, THE BALLOON WAS UNABLE TO BE REMOVED AFTER DEFLATION. THE TREK RX BDC WAS REMOVED TOGETHER WITH THE OTHER DEVICES AS A UNIT. ANOTHER 5.0X15MM TREK RX BDC WAS USED AND WAS UNABLE TO BE REMOVED AGAIN AFTER DEFLATION. THE TREK RX BDC WAS REMOVED TOGETHER WITH THE GUIDE WIRE AS A UNIT. 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 15657726 ↗
• MalfunctionJun 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, MODERATELY CALCIFIED AND MODERATELY TORTUOUS VESSEL IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. THE 5.0X15MM TREK RX BALLOON DILATATION CATHETER (BDC) HAD NO RESISTANCE DURING REMOVAL OF THE PROTECTIVE SHEATH AND DURING ADVANCEMENT. THE BDC WAS INFLATED TWICE. FIRST INFLATION WAS AT 8 ATMOSPHERES (ATMS) FOR 10 SECONDS, HOWEVER, THE BALLOON RUPTURED ON THE SECOND INFLATION AT 12 ATMS FOR 10 SECONDS. THE BDC WAS SOAKED IN SALINE PRIOR TO USE AND WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND THE LESION WAS NOTED TO BE DILATATED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. 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 14601861 ↗
• InjuryDec 17, 2021Entrapment of Device; Material Separation; Failure to Deflate; Entrapment of Device; Material Separation; Failure to Deflate

  IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE LEFT MAIN (LM) CORONARY ARTERY LESION. LM BALLOON DILATATION WAS PERFORMED BY A TREK RX DILATATION CATHETER. FOLLOWING, THE BALLOON WAS UNABLE TO DEFLATE AND BECAME STUCK IN THE LM. THE PATIENT WENT INTO A CRITICAL CONDITION. AN EMERGENCY ACCESS SITE WAS CREATED IN THE FEMORAL ARTERY AND THE INFLATED BALLOON WAS SUCCESSFULLY REMOVED VIA SNARE. DURING REMOVAL ATTEMPTS, THE DEVICE HAD SEPARATED IN TWO PLACES. ONCE OUTSIDE THE ANATOMY, THE BALLOON WAS NOTED RIGID AND UNABLE TO DEFLATE. REPORTEDLY, THERE IS SUSPECTED FAULT WITH THE TREK DEVICES INTERNAL BRAIDING, ALTHOUGH THIS WAS NOT CONFIRMED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 13026087 ↗
• MalfunctionMay 21, 2021Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. A 5X15MM TREK BALLOON WAS INFLATED TWICE WHEN THE BALLOON BURST. 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 11866598 ↗
• MalfunctionFeb 2, 2021Failure to Fold; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Fold; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MAIN TRUNK. A 5X15MM TREK BALLOON WAS NOT PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THE DEVICE WAS ADVANCED TO THE LESION AND INFLATED ONCE AT 11 ATMOSPHERES FOR 10 SECONDS WITHOUT ISSUE. IT TOOK 2-3 SECONDS FOR THE TREK TO DEFLATE COMPLETELY BUT IT DID NOT REFOLD TIGHTLY BACK PROPERLY. DURING REMOVAL OF THE TREK IT KEPT GETTING STUCK AT THE GUIDING CATHETER ENTRANCE. THEREFORE, THE BALLOON AND GUIDE CATHETER WERE REMOVED ALTOGETHER AS A SINGLE UNIT. THERE WAS NO NEED FOR AN ADDITIONAL BALLOON AS THE TREK HAD COMPLETED WHAT THEY NEEDED FOR THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11267653 ↗
• InjuryNov 17, 2020Deflation Problem; Off-Label Use; Material Separation; Deflation Problem; Off-Label Use; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT PULMONARY ARTERY. A 5.0X15MM TREK BALLOON WAS ADVANCED AND INFLATED AT THE FIRST INFLATION AT 8 ATMOSPHERES. THE BALLOON WOULD NOT DEFLATE AFTER ATTEMPTING MULTIPLE TIMES WITH DIFFERENT SIZE SYRINGES. THEREFORE, THE BALLOON WAS INTENTIONALLY INFLATED MORE TO RUPTURE. ONCE THE BALLOON RUPTURED, DURING REMOVAL THE SHAFT SEPARATED INTO TWO PIECES AND A SNARE WAS USED TO RETRIEVED THE SEPARATED PORTION. NO OTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10853234 ↗
• MalfunctionOct 26, 2020Deflation Problem; Off-Label Use; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Off-Label Use; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PULMONARY ARTERY. THE 5.0X15MM TREK BALLOON DILATATION CATHETER WAS PRESSURIZED TWICE TO 6 ATMOSPHERES. THE FIRST INFLATION WAS COMPLETED WITHOUT ISSUE. ON THE SECOND INFLATION, THE BALLOON FAILED TO DEFLATE. NEGATIVE PRESSURE WAS HELD FOR SEVERAL MINUTES AS THE BALLOON NEVER DEFLATED WITH MULTIPLE ASPIRATION ATTEMPTS TO DEFLATE THE BALLOON. THERE WAS A DELAY OF 30 MINUTES DUE TO ADDITIONAL IMAGES REQUIRED DURING THE ATTEMPTS MADE TO REMOVE THE DEVICE. THE BALLOON WAS FINALLY REMOVED FULLY INFLATED USING FORCE AND THE GUIDING CATHETER. ALTHOUGH A CLINICALLY SIGNIFICANT DELAY WAS REPORTED, THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS DUE TO OUR DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10733574 ↗
• MalfunctionOct 12, 2020Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  ADDITIONAL INFORMATION: THE BALLOON DILATATION CATHETER WAS REMOVED WITH THE GUIDE CATHETER BECAUSE IT WAS IMPOSSIBLE TO DEFLATE AND REMOVE IT FROM THE GUIDING CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10665529 ↗
• MalfunctionJun 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED DE NOVO PROXIMAL RIGHT CORONARY ARTERY (PRCA) THAT IS 90% STENOSED. A 5.0X15MM NC TREK WAS ADVANCED AND ONCE AT THE LESION WAS INFLATED TO 6 ATMOSPHERE (ATM) WHEN IT RUPTURED AT THE SECOND INFLATION. ANOTHER NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10112563 ↗
• InjuryMar 4, 2020Deflation Problem; Off-Label Use; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Off-Label Use; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  ADDITIONAL INFORMATION RECEIVED: THE SEPARATION OCCURRED ON THE SHAFT NOT THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9786424 ↗
• MalfunctionOct 18, 2019Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY. A 5.0X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS BEING USED TO POST-DILATE AN UNSPECIFIED STENT; HOWEVER, THE BALLOON WOULD NOT DEFLATE. MULTIPLE ATTEMPT TO DEFLATE THE BALLOON WITH THE INDEFLATOR WERE MADE AND THE BDC WAS EVEN FLUSHED WITH SALINE IN AN ATTEMPT TO DILUTE THE 50/50 CONTRAST MIX BUT WERE ALL UNSUCCESSFUL. THE BDC WAS REMOVED WITH THE BALLOON PARTIALLY INFLATED. AFTER REMOVAL, IT WAS NOTED THAT THE BALLOON WAS PARTIALLY SEPARATED FROM THE SHAFT ALTHOUGH IT WAS STILL ALL IN ONE PIECE. A 5.0X15MM TREK RX BDC WAS ADVANCED AND INFLATED, BUT THE BALLOON WOULD NOT DEFLATE. MULTIPLE ATTEMPTS TO DEFLATE THE BALLOON WERE MADE WITH THE INDEFLATOR AND THE BALLOON PARTIALLY DEFLATED. DURING REMOVAL THE BDC COULD NOT GO THROUGH THE GUIDING CATHETER; THEREFORE, BOTH WERE REMOVED AS A UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADDITIONAL INTERVENTION. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9210672 ↗
• InjuryAug 26, 2019Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A VEIN BYPASS. THE 5.0X15 MM TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED TO 12 ATMOSPHERES (ATM) AND THEN IT WAS NOT POSSIBLE TO DEFLATE THE BALLOON. IT WAS ATTEMPTED TO DEFLATE WITH A MANUAL PUMP FIRST AND THEN THE BDC HAD TO BE PULLED INTO THE AORTA TO BE BURST BEFORE IT COULD BE REMOVED. THERE WERE NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8932007 ↗
• MalfunctionOct 24, 2017Detachment Of Device Component; Kinked; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS SAPHENOUS VEIN GRAFT. A 5.0 X 15 MM TREK BALLOON CATHETER WAS USED. THE DEVICE WAS BEING ADVANCED OVER AN UNSPECIFIED GUIDE WIRE THAT WAS INSIDE THE ANATOMY, AND DID NOT MEET ANY RESISTANCE DURING ADVANCEMENT. HOWEVER, IT WAS NOTED THAT THE SHAFT OF THE DEVICE MAY HAVE BEEN KINKED BEFORE LOADING ONTO THE GUIDE WIRE. THE HYPOTUBE THEN SEPARATED FROM THE DEVICE OUTSIDE THE ANATOMY; THEREFORE, THE DEVICE WAS SIMPLY PULLED OUT. AN UNSPECIFIED BALLOON CATHETER WAS THEN USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6975020 ↗
• MalfunctionMay 31, 2017Collapse; Difficult to Remove

  IT WAS REPORTED THAT WHILE UNPACKAGING A 5.0X15MM TREK RX BALLOON DILATATION CATHETER (BDC), THE PROTECTIVE SHEATH WAS DIFFICULT TO REMOVE. UPON REMOVAL THE DISTAL TIP APPEARED TO BE WRINKLED / CRUMPLED. THE DEVICE WAS NOT USED IN PATIENT ANATOMY AND THERE WAS NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. ANOTHER UNSPECIFIED DEVICE WAS USED TO TREAT THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6602898 ↗